Manes2019 PDF

Guideline
Endoscopic management of common bile duct stones:

European Society of Gastrointestinal Endoscopy (ESGE) guideline
Authors
Gianpiero Manes1, Gregorios Paspatis2, Lars Aabakken3, Andrea Anderloni4, Marianna Arvanitakis5, Philippe
Ah-Soune 6, Marc Barthet 7, Dirk Domagk 8, Jean-Marc Dumonceau9, Jean-Francois Gigot 10, Istvan Hritz 11, George
This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.
Karamanolis12, Andrea Laghi 13, Alberto Mariani 14, Konstantina Paraskeva15, Jürgen Pohl 16, Thierry Ponchon17, Fredrik
Swahn18, Rinze W. F. ter Steege19, Andrea Tringali 20, Antonios Vezakis 21, Earl J. Williams22, Jeanin E. van Hooft 23
Institutions 18 Center for Digestive Diseases, Karolinska University

1 Department of Gastroenterology, ASST Rhodense, Hospital and Division of Surgery, CLINTEC, Karolinska
Rho and Garbagnate M.se Hospitals, Milan, Italy Institute, Stockholm, Sweden
2 Gastroenterology Department, Benizelion General 19 Department of Gastroenterology and Hepatology,
Hospital, Heraklion, Crete, Greece University of Groningen, University Medical Center
3 GI Endoscopy, Rikshospitalet University Hospital, Groningen, Groningen, The Netherlands
Hospital and Faculty of Medicine, University of Oslo, 20 Digestive Endoscopy Unit, Catholic University, Rome,
Oslo, Norway Italy
4 Digestive Endoscopy Unit, Division of Gastroenterology, 21 Gastroenterology Unit, 2 Department of Surgery,
Humanitas Research Hospital, Rozzano, Milan, Italy School of Medicine, National and Kapodistrian
5 Department of Gastroenterology, Hepatology and University of Athens, Athens, Greece
Digestive Oncology, Erasme University Hospital 22 Department of Gastroenterology, Royal Bournemouth
Université Libre de Bruxelles, Brussels, Belgium Hospital, Bournemouth, UK
6 Service d'Hépato-Gastroentérologie, Hôpital Saint- 23 Department of Gastroenterology and Hepatology,
Musse, Toulon, France Amsterdam University Medical Center, University of
7 Service d'Hépato-gastroentérologie, Hôpital Nord, Amsterdam, Amsterdam, The Netherlands
Marseille, France
8 Department of Medicine B, University of Münster, Bibliography
Münster, Germany DOI https://doi.org/10.1055/a-0862-0346
9 Gedyt Endoscopy Center, Buenos Aires, Argentina Published online: 2019 | Endoscopy
10 Department of Abdominal Surgery and © Georg Thieme Verlag KG Stuttgart · New York
Transplantation, Cliniques Universitaires Saint-Luc, ISSN 0013-726X
Université Catholique de Louvain, Brussels, Belgium
11 Semmelweis University, 1st Department of Surgery, Corresponding author
Endoscopy Unit, Budapest, Hungary Gianpiero Manes, MD, Department of Gastroenterology,
12 Academic Department of Gastroenterology, Laiko ASST Rhodense, Rho and Garbagnate M.se Hospitals, Viale
General Hospital, Medical School, National and Forlanini 95, 20024 Garbagnate M.se, Milano, Italy
Kapodistrian University of Athens, Athens, Greece gimanes@tin.it
13 Pathological Sciences, Sapienza University, Rome, Italy
14 Pancreato-Biliary Endoscopy and Endosonography
Appendix 1s, Tables 1s – 14s
Division, Pancreas Translational & Clinical Research
Online content viewable at:
Center, Vita-Salute San Raffaele University, IRCCS
https://doi.org/10.1055/a-0862-0346
San Raffaele Scientific Institute, Milan, Italy
15 Gastroenterology Unit, Konstantopoulio General
Hospital, Athens, Greece
16 Department of Gastroenterology and Interventional
Endoscopy, Klinikum Friedrichshain, Berlin, Germany
17 Department of Digestive Diseases, Hôpital Edouard
Herriot, Lyon, France
Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

MAIN RECO MMENDAT IONS – moderate, within 48 – 72 hours
ESGE recommends offering stone extraction to all patients – mild, elective.
with common bile duct stones, symptomatic or not, who Strong recommendation, low quality evidence.
are fit enough to tolerate the intervention. ESGE recommends endoscopic placement of a temporary
Strong recommendation, low quality evidence. biliary plastic stent in patients with irretrievable biliary
ESGE recommends liver function tests and abdominal ultra- stones that warrant biliary drainage.
sonography as the initial diagnostic steps for suspected Strong recommendation, moderate quality of evidence.
common bile duct stones. Combining these tests defines ESGE recommends limited sphincterotomy combined with
the probability of having common bile duct stones. endoscopic papillary large-balloon dilation as the first-line
Strong recommendation, moderate quality evidence. approach to remove difficult common bile duct stones.
ESGE recommends endoscopic ultrasonography or magnet- Strong recommendation, high quality evidence.
ic resonance cholangiopancreatography to diagnose com- ESGE recommends the use of cholangioscopy-assisted in-
mon bile duct stones in patients with persistent clinical sus- traluminal lithotripsy (electrohydraulic or laser) as an effec-
picion but insufficient evidence of stones on abdominal ul- tive and safe treatment of difficult bile duct stones.
trasonography. Strong recommendation, moderate quality evidence.
Strong recommendation, moderate quality evidence. ESGE recommends performing a laparoscopic cholecystect-
ESGE recommends the following timing for biliary drainage, omy within 2 weeks from ERCP for patients treated for cho-
preferably endoscopic, in patients with acute cholangitis, ledocholithiasis to reduce the conversion rate and the risk
classified according to the 2018 revision of the Tokyo of recurrent biliary events.
Guidelines: Strong recommendation, moderate quality evidence.
– severe, as soon as possible and within 12 hours for
patients with septic shock
PUBLI C AT I ON IN FOR MAT I ON

2 Methods
This Guideline is an official statement of the European The ESGE commissioned this Guideline (chair J.v.H.) and ap-
Society of Gastrointestinal Endoscopy (ESGE). It provides pointed a guideline leader (G.M.), who invited the listed au-
practical advice on how to manage common bile duct thors to participate in the project development. The key ques-
stones. The Grading of Recommendations Assessment, tions were prepared by the coordinating team (G.M. and G.P.)
Development, and Evaluation (GRADE) system was adop- and then approved by the other members. The coordinating
ted to define the strength of recommendations and the team formed task-force subgroups, each with its own leader,
quality of evidence. and divided the key topics among these task forces (Appen-
dix 1 s; see online-only Supplementary Material).
Each task force performed a systematic literature search to
prepare evidence-based and well-balanced statements on their
1 Introduction assigned key questions. The coordinating team independently
Gallstones are a very common problem in developed countries performed systematic literature searches, with PubMed/Med-
[1 – 3]. Most patients with gallstones remain asymptomatic line, EMBASE, the Cochrane Library, and the internet being fi-
throughout their lifetime [4, 5], but 10 % – 25 % of them may de- nally searched for papers published until April 2018. The search
velop biliary pain or complications [6 – 9], with an annual risk of focused on fully published randomized controlled trials (RCTs),
about 2 % – 3 % for symptomatic disease [10] and 1 % – 2 % for meta-analyses, and prospective series. Retrospective analyses,
major complications [11]. The development of symptomatic case series, and abstracts were also included if they addressed
disease and complications is mostly related to the migration of topics not covered in the prospective studies. The literature
stones into the common bile duct (CBD). Common bile duct search was restricted to papers published in English after 1990.
stones (CBDSs) may be treated by endoscopic retrograde After further exploration of their content, articles that con-
cholangiopancreatography (ERCP) or surgically during chole- tained relevant data were then included and summarized in the
cystectomy. The aim of this evidence- and consensus-based literature tables for the key topics (Tables 1s – 14 s). All select-
Guideline, commissioned by the European Society of Gastro- ed articles were graded by the level of evidence and strength of
intestinal Endoscopy (ESGE), is to provide practical advice on recommendation according to the GRADE system [12]. Each
how to manage patients with CBDSs. It considers diagnostic task force developed a draft and proposed statements on their
strategies in patients with suspected CBDSs, as well as the dif- assigned key questions, which were discussed and voted on
ferent therapeutic options available for CBDSs. during plenary meetings held in February 2017 in Düsseldorf,
Germany, and in October 2017 in Barcelona, Spain. In April

Guideline
3 General principles
A BB R E VI AT I ONS
ABP acute biliary pancreatitis 3.1 Epidemiology
ASGE American Society for Gastrointestinal
Endoscopy Gallstones are common with a prevalence as high as 10 % – 15 %
CBD common bile duct in developed countries [1 – 3] and an overall cumulative inci-
CBDS common bile duct stones dence of gallstone formation of 0.60 % per year [13].
CI confidence interval According to a large Swedish registry [14], the prevalence of
CT computed tomography CBDSs detected during intraoperative cholangiography (IOC) is
DPOC direct peroral cholangioscopy 11.6 % in patients with symptomatic gallbladder stones; other
EHL electrohydraulic lithotripsy prospective studies have described a prevalence of CBDSs
EPLBD endoscopic papillary large-balloon dilation detected during IOC ranging from 4.6 % to 12 % in Europe
ERCP endoscopic retrograde cholangiopancreato- [15, 16], and up to 20.9 % in South America [17]. A prevalence
graphy of 8 % – 18 % for CBDSs in patients with symptomatic gallblad-
ESGE European Society of Gastrointestinal Endos- der stones has been proposed [18].
copy No studies have focused on the prevalence of CBDSs in pa-
ESWL extracorporeal shock wave lithotripsy tients with asymptomatic gallbladder stones, as most studies
EUS endoscopic ultrasonography are based on IOC during cholecystectomy for symptomatic dis-
IOC intraoperative cholangiography ease.
IRR incidence rate ratio
LFT liver function test 3.2 The natural history of CBDSs and recommended
MBC mother – baby cholangioscopy handling
MRCP magnetic resonance cholangiopancreato-
graphy RECOMMENDATION
NR-ERCP non-radiation ERCP ESGE recommends offering stone extraction to all
NSAID nonsteroidal anti-inflammatory drug patients with common bile duct stones, symptomatic or
OR odds ratio not, who are fit enough to tolerate the intervention.
OTS out of the scope Strong recommendation, low quality evidence.
PTBD percutaneous transhepatic biliary drainage
RCT randomized controlled trial
RR relative risk The natural history of CBDSs is not well described, but data
SD standard deviation from the GallRiks study [14] suggest that, if CBDSs are detect-
SEMS self-expanding metal stent ed, they should be removed to reduce the risk of complications
SOC single-operator cholangioscopy over time: of the 3969 patients with CBDSs on IOC, 594 had
TTS through the scope their CBDSs left in place. During follow-up, ranging from 0 to 4
UDCA ursodeoxycholic acid years, 25.3 % of patients with CBDSs in situ developed compli-
cations (pancreatitis, cholangitis, or obstruction of the bile
duct) vs. 12.7 % of patients who had undergone CBDS removal
(odds ratio [OR] 0.44, 95 %CI 0.35 – 0.55). The likelihood of an
2018, a draft prepared by the coordinating team was sent to all unfavorable outcome increased with the size of the CBDS, but
group members. the incidence of complications even for CBDSs less than 4 mm
After agreement of all group members, the manuscript was was 5.9 % vs. 8.9 % for larger CBDSs (OR 0.52, 95 %CI 0.34 –
reviewed by two members of the ESGE Governing Board, and by 0.79).
two external reviewers and was then sent for further comments These data support a strategy of extracting CBDSs regard-
to the ESGE National Societies and Individual Members. The less of size, although some previous studies have suggested
manuscript was then submitted to Endoscopy for publication. that small unsuspected stones can pass spontaneously without
All authors agreed on the final revised manuscript. This Guide- the need for intervention [16, 19 – 22] (Table 1 s). The sponta-
line was issued in 2019 and will be considered for review in neous passage of small CBDSs without serious complications
2023, or sooner if new and relevant evidence becomes avail- has been documented by Collins [15] in 24 of 46 patients with
able. Any updates to the Guideline in the interim will be noted a filling defect observed on IOC in whom a cystic duct catheter
on the ESGE website: http://www.esge.com/esgeguidelines. was left in place after laparoscopic cholecystectomy. The
html. asymptomatic migration of small (less than 8 mm) stones has
also been noted in the interval between diagnosis at endo-
scopic ultrasonography (EUS) and ERCP [23].
In spite of the absence of controlled studies, some factors
favor a policy of stone extraction in asymptomatic CBDSs: the
occurrence of unfavorable outcomes is not different in patients

classified as asymptomatic or symptomatic [14]; the lifetime The risk of having CBDSs in spite of normal LFTs and ultraso-
risk of untreated CBDSs is unknown and may be higher than nography has been adequately evaluated in two studies
that reported; severe complications such as cholangitis, pan- [35, 36]. In a large study including 765 patients with ERCP-
creatitis, or obstructive jaundice can occur without preceding proven CBDSs, 541 had previously documented LFTs and 29
warning symptoms [24]. A conservative approach can only be (5.4 %) had normal LFTs. Age more than 55 years and the pres-
considered in patients where the risks of surgical or endoscopic ence of pain were independently associated with normal LFTs in
CBDS extraction are higher than the risks of leaving stones in patients with CBDSs [35]. A more recent retrospective study in-
situ. When offering stone extraction to asymptomatic patients cluding 413 patients with gallstones who underwent ultrasono-
with CBDSs, patients should be made aware of the limited evi- graphy and magnetic resonance cholangiopancreatography
dence regarding this recommendation and of the risk of ERCP, (MRCP) for suspected CBDSs showed that 109 /413 (26.3 %)
which may be elevated in asymptomatic patients [25]. had CBDSs revealed on the MRCP, but in 7 /109 (6.4 %) ultraso-
nography and LFTs (one or more of total bilirubin, ALP, AST,
4 Defining the risk of having CBDSs ALT, or GGT) were normal [36] (Table 2 s).
4.1 Initial evaluation 4.2 Role of EUS and MRCP
RECO MMENDATION RECOMMENDATION

ESGE recommends liver function tests and abdominal ul- ESGE recommends endoscopic ultrasonography or mag-
trasonography as the initial diagnostic steps for suspect- netic resonance cholangiopancreatography to diagnose
ed common bile duct stones. Combining these tests de- common bile duct stones in patients with persistent clin-
fines the probability of having common bile duct stones. ical suspicion but insufficient evidence of stones on ab-
Strong recommendation, moderate quality evidence. dominal ultrasonography.
Strong recommendation, moderate quality evidence.
Patients at risk of having CBDSs, such as patients with gall-

stones who present with symptoms, undergo non-invasive The diagnostic accuracy of EUS and MRCP for the detection
tests such as liver function tests (LFTs) and abdominal ultra- of CBDSs has been widely investigated. Meeralam and co-work-
sound as triage to determine the need for further evaluations ers in a recent meta-analysis of five head-to-head studies [37]
to confirm the presence of CBDSs. demonstrated that diagnostic accuracy was high for both
A recent systematic review including five studies assessed methods (sensitivity 97 % vs. 90 % and specificity 87 % vs. 92 %
the diagnostic accuracy of LFTs (1 study) and ultrasonography for EUS and MRCP, respectively), but the overall diagnostic OR
(5 studies) for CBDSs [26]. All studies were of poor methodolo- of EUS was significantly higher (P = 0.008). They showed that
gical quality. The sensitivities of bilirubin (cutoff > 22.23 μmol/L this was mainly because of the significantly higher sensitivity
or > 1.3 mg/dL) and alkaline phosphatase (cutoff > 125 U/L) for of EUS, as compared with that of MRCP, especially in the detec-
CBDSs were 84 % (95 % confidence interval [CI] 64 % – 95 %) and tion of small stones, while the specificity was not significantly
91 % (95 %CI 74 % – 99 %), respectively; the specificities were 91 % different. High accuracy for both methods was demonstrated
(95 %CI 86 % – 94 %) and 79 % (95 %CI 74 % – 84 %), respectively. by another meta-analysis including 18 studies (2 comparative,
Regarding ultrasonography, sensitivity was 73 % (95 %CI 44 % – 5 evaluating MRCP alone and 11 EUS alone) [38]. Sensitivity
95 %) and specificity was 91 % (95 %CI 84 % – 95 %). Ultrasono- and specificity were respectively 95 % (95 %CI 91 % – 97 %) and
graphy findings were considered positive if there was visualiza- 97 % (95 %CI 94 % – 99 %) for EUS, and 93 % (95 %CI 87 % – 96 %)
tion of CBDSs and/or CBD dilatation. and 96 % (95 %CI 90 % – 98 %) for MRCP.
Multidetector multiphase computed tomography (CT), Various considerations may help to select the most ade-
when used to investigate patients with CBDSs, had a sensitivity quate procedure if both are available and the patient does not
of 78 % and a specificity of 96 % in a retrospective study [27]. present any factors that would impede MRCP, such as claustro-
The size and composition of the stones significantly affects CT phobia, obesity, cardiac pacemaker, or metal clips. Sonnem-
accuracy, which is significantly lower when stones are less than berg and colleagues [39], performing a threshold analysis on
5 mm (56.5 % vs. 81.2 %) or have a similar density to bile [28]. costs, concluded that, for a pretest probability of CBDSs
Coronal reconstruction does not increase the diagnostic effi- < 40 %, MRCP would represent the procedure of choice. For a
ciency of CT scanning [29]. pretest probability in the range 40 % – 91 %, EUS should be the
The pretest probability of CBDSs in suspected patients is es- preferred imaging modality, because it allows an ERCP to be
sential to select which patients will benefit most from a more performed in the same session if the EUS results are positive
accurate assessment. Several predictive models have been de- for CBDSs. However, the applicability of their results is limited
veloped combining clinical, biochemical, and ultrasonography because they are strictly influenced by the costs of each proce-
findings in order to identify high risk patients [30 – 34] (Ta- dure and local rules of reimbursement. Furthermore, logistic is-
ble 2s). sues regarding the scheduling of an EUS and an ERCP during the
same examination slot should be taken into consideration. The
minimally invasive nature of MRCP, its suitability if there is al-

Guideline
Symptomatic gallstone disease
LFTs and US
Low likelihood of CBDS Intermediate likelihood of CBDS High likelihood of CBDS

normal LFTs and US abnormal LFTs and/or CBD dilation features of cholangitis or
(no CBD dilation at US) on US CBDSs identified at US
Perform EUS / MRCP
Proceed to preoperative ERCP or
Proceed to Negative Positive
direct to cholecystectomy with
cholecystectomy for CBDSs for CBDSs
CBD exploration
▶ Fig. 1 Diagnostic algorithm for suspected common bile duct stones (CBDSs). LFTs, liver function tests; US, ultrasound; CBD, common
bile duct; EUS, endoscopic ultrasonography; MRCP, magnetic resonance cholangiopancreatography; ERCP, endoscopic retrograde cholangio-
pancreatography.
tered gastroduodenal anatomy, and its ability to visualize the subgroup of patients at higher risk, such as those with biliary
whole biliary tree should also be considered when deciding be- obstruction and incomplete biliary drainage [41].
tween the two methods. The role of antibiotic prophylaxis in reducing the rate of cho-
langitis has been evaluated by several RCTs, which differed sig-
4.3 An algorithm for investigating suspected CBDSs nificantly in terms of type of antibiotic, duration of administra-
▶ Fig. 1 depicts an algorithm for investigating suspected tion, and indications for ERCP [42 – 47] and three meta-analyses
CBDSs. ERCP can be performed in patients without cholangitis (Table 3 s) [48 – 50].
only when CBDSs are visible on imaging modalities that have a The most recent meta-analysis of nine RCTs [50] (1573 pa-
high specificity. Normal LFTs and ultrasonography indicate a tients) indicated that antibiotic prophylaxis could reduce bac-
low risk of CBDSs and no further evaluations are recommended, teremia and may prevent cholangitis and septicemia in patients
unless the patient continues to have symptoms that suggest undergoing elective ERCP. However, in random-effects meta-
CBDSs. All other pictures depict an intermediate risk of CBDSs, analyses, only the effect on bacteremia remained significant; if
which should prompt further investigation by EUS or MRCP. In ERCP resolved the biliary obstruction at the first procedure,
the absence of a morphological diagnosis of CBDSs, ERCP there was no significant benefit in using antibiotic prophylaxis
should be performed immediately only in patients with a clini- to prevent cholangitis (relative risk [RR] 0.98, 95 %CI 0.35 –
cal picture of cholangitis (see section 8.1). 2.69, only three trials) [50].
Cotton et al. [51] reported in a retrospective series of 11 484
5 Performing ERCP ERCPs performed over 11 years that, in spite of a progressive re-
duction in the use of antibiotic prophylaxis over the years (from
5.1 Antibiotic prophylaxis 95 % to 25 % of ERCP patients), the incidence of infections de-
creased from 0.48 % to 0.25 %. In the multivariate model, endo-
RECO MMENDATION scopic treatment of CBDSs was not associated with an in-
ESGE suggests against the use of routine antibiotic pro- creased risk of developing cholangitis after ERCP. All these
phylaxis before ERCP for bile duct stones. data suggest that not all patients benefit from antibiotic pro-
Weak recommendation, moderate quality evidence. phylaxis and that patients with CBDSs should not routinely re-
ceive antibiotic prophylaxis before ERCP (Table 3 s).
Patients with ongoing acute cholangitis should already be
The ERCP procedure is often associated with the occurrence receiving antibiotics at the time of intervention and additional
of bacteremia [40], which is mostly transient. The occurrence antibiotics are not recommended.
of cholangitis is an infrequent event, which occurs mainly in a

Antibiotic prophylaxis should be considered for patients Two multicenter RCTs have compared the efficacy of balloon
with refractory CBDSs undergoing extracorporeal shock wave vs. basket catheters for the extraction of CBDSs sized ≤ 10 mm
lithotripsy (ESWL) for CBD clearance [52, 53]. No data are avail- or < 11 mm after endoscopic sphincterotomy [62, 63]. In one
able for patients undergoing cholangioscopy-assisted lithotrip- RCT (158 patients), the balloon catheter achieved a higher
sy; nevertheless, antibiotic prophylaxis is likely to be advisable clearance rate than the basket catheter (92.3 % vs. 80.0 %)
as two recent prospective studies have demonstrated that [62]. The other RCT (184 patients) reported similar efficacies
cholangioscopy per se may carry a risk of bacteremia that for basket and balloon catheters for stone extraction, but a
ranges from 8.8 % to 13.9 % and that up to 9.7 % of patients stone diameter of < 6 mm was independently associated with
may develop infective complications despite the use of post- failed stone removal within 10 minutes using a basket catheter,
procedure antibiotics [54]. Biopsy sampling, older age, pre- because of the inability to grasp the stone with the basket [63].
vious stent placement, and laser lithotripsy or electrohydraulic No differences in safety were reported in the two studies.
lithotripsy (EHL) were likely to increase the risk of developing ei- Stone extraction baskets and balloons are commercially
ther infection or persistent bacteremia. available in various configurations. As yet, no comparative
Antibiotic prophylaxis in some special conditions, such as in studies between various models of basket catheters exist [64].
liver transplant patients, was considered to be out of the scope In general, choosing which device to use depends mainly on the
of this guideline. anatomy of the bile duct, the stone characteristics, financial
considerations, and personal preferences.
5.2 Gaining access to the biliary tree
5.4 Biliary stenting for incomplete removal of CBDSs
RECO MMENDATION
ESGE recommends that an adequate exit for the stones RECOMMENDATION
that are to be removed should be provided according to ESGE recommends endoscopic placement of a temporary
the papilla and common bile duct anatomy and the stone biliary plastic stent in patients with irretrievable biliary
size. stones that warrant biliary drainage.
Strong recommendation, low quality evidence. Strong recommendation, moderate quality of evidence.
The various technical aspects, either of deep biliary cannula- Endoscopic sphincterotomy with stone extraction has suc-
tion or endoscopic sphincterotomy, have been reviewed in cess rates of 80 % – 90 % in the treatment of CBDSs [65]. When
other guidelines [55, 56]. A critical step to obtain successful CBDSs cannot be completely removed, a plastic stent is often
stone extraction is to provide an adequate exit for the stones placed to relieve the obstruction, before a second attempt at
that are to be removed by endoscopic sphincterotomy alone, stone extraction is made or a subsequent surgical intervention
endoscopic papillary balloon dilation alone, or a combination is undertaken. An indwelling endoprosthesis may reduce the
of both [55, 57]. Papillary balloon dilation alone however re- volume and number of stones, as reported by nine studies
mains unpopular and is not advocated for routine use as it is (three prospective [66 – 68] and six retrospective [69 – 74]) in-
associated with a lower technical success for stone clearance, volving a total of 364 patients (Table 4 s). The success rate for
the need for mechanical lithotripsy more frequently than with stone removal after previous ERCP with biliary stenting has
endoscopic sphincterotomy, and a presumed increased risk of been reported to range from 44 % to 96 % (Table 5 s) [66 – 73,
pancreatitis [55, 58, 59]. At present, the use of primary papil- 75, 76].
lary balloon dilation without endoscopic sphincterotomy is The mechanism by which stones change in number and size
considered mainly in patients with coagulopathy or with al- is unclear. It is likely that continuous friction between the plas-
tered anatomy who have stones smaller than 8 mm [55]. The tic stent and the stones produces stress forces that facilitate
appropriate length of endoscopic sphincterotomy should be the disintegration of stones and reduce their size [71].
adjusted according to the papillary anatomy and stone size. There are no studies comparing the different types of bili-
Data on the effect of endoscopic sphincterotomy length on ary plastic stents or plastic vs. metal stents. Similarly, there
the rate of stone recurrence are presently contradictory [60, are no specific prospective comparative data with regard to
61]. whether one or more than one biliary stent is preferable in pa-
tients with incomplete stone removal. In the only retrospec-
5.3 Stone extraction tive published study, 64 elderly patients (≥ 65 years) with
large (≥ 20 mm) or multiple (≥ 3) CBDSs underwent placement
RECO MMENDATION of single or double plastic stents at the time of initial ERCP.
ESGE recommends that balloon and basket catheters are Approximately 3 months later, stone removal was attempted
equally effective and safe for common bile duct stone at a second ERCP using standard techniques. Double plastic
removal. biliary stenting (7 or 8.5 Fr) was superior to single stenting
Strong recommendation, moderate quality evidence. (8.5 Fr) in maintaining higher 3-month stent patency rates (P
= 0.008), but was similar in terms of reducing the size and

Guideline
number of stones [77]. No differences in complications were 14.4, respectively), and that patients aged > 80 years had a
found. two-fold risk of procedure-related death (IRR 2.4; 95 %CI 1.3 –
In recent years, some studies with small patient series have 4.5) [82]. However, definitive stenting for CBDSs should be ap-
evaluated the management of incomplete stone removal using proached with caution. Six series, including 230 patients [83 –
fully covered self-expanding metal stents (SEMSs) (Table 6 s) 88], have reported a complication rate for definitive biliary
[78 – 80]. In the largest retrospective case series [80], 44 pa- stenting, mainly cholangitis, of 34 % – 63 %, with a 2.3 % – 23.5 %
tients received covered SEMSs (diameter 10 mm, length 60 mortality rate during 16 – 39 months of follow-up (Table 7 s).
mm). After a median in-stent duration of 8 weeks, 36/42 stents
(82 %) were removed with successful duct clearance. The me- 5.6 Role of dissolution therapy
dian post-procedure follow-up was 15 months. Four patients
(9 %) developed post-ERCP pancreatitis (mild in 3, moderate RECOMMENDATION
in 1), two patients (4 %) developed post-procedure cholangi- EGSE suggests against the use of ursodeoxycholic acid or
tis, and one (2 %) hematemesis. During follow-up, 10 patients other choleretic agents, either for the treatment of
(22.7 %) had incidental stent migration (distally in 6, proximal- CBDSs or to prevent the recurrence of CBDSs after endo-
ly in 4), but in none of them was it clinically significant, with scopic clearance.
all being discovered at the time of subsequent ERCP. Weak recommendation, moderate quality of evidence.
At present, covered SEMSs can be considered as an alterna-
tive to plastic stents to drain the bile ducts after unsuccessful
stone removal, but there are uncertainties over how long the Ursodeoxycholic acid (UDCA) with or without terpene prep-
stents should be left in place and the cost – benefit ratio of the aration (Rowachol) has been suggested as a complementary
treatment. treatment to induce stone reduction when used together with
biliary endoprostheses, but in two RCTs the addition of UDCA
5.5 Timing of stent removal/exchange therapy to endoprosthetic treatment showed no effect on
stone size reduction or successful duct clearance [66, 68].
RECO MMENDATION UDCA has been administered with the aim of reducing the
ESGE recommends that a plastic stent placed because of rate of stone recurrence after successful removal of CBDSs in
incomplete common bile duct stone clearance should be patients with risk factors such as CBD dilatation, delayed biliary
removed or exchanged within 3 – 6 months to avoid infec- emptying (biliary stricture, papillary stenosis), or the presence
tious complications. of gallstones, a periampullary diverticulum, or systemic dis-
Strong recommendation, moderate quality of evidence. eases that cause stone formation [89 – 91]. Two RCTs have in-
vestigated this issue and both revealed no significant difference
regarding stone recurrence [92, 93].
RECO MMENDATION
6 Difficult stones
ESGE recommends against the use of definitive biliary
stenting in patients with incomplete common bile duct “Difficult” biliary stones are defined according to their diameter
stone clearance because of the high complication and (> 1.5 cm), number, unusual shape (barrel-shaped), or location
mortality rates on medium-term follow-up. (intrahepatic, cystic duct), or because of anatomical factors
Strong recommendation, moderate quality of evidence. (narrowing of the bile duct, distal to the stone, sigmoid-shaped
CBD, stone impaction, shorter length of the distal CBD, or
acute distal CBD angulation < 135°) [94, 95]. Clearance of a dif-
Intervals of 3 – 6 months for routine ERCP and stent change ficult stone cannot usually be obtained using standard tech-
are commonly recommended to reduce the rate of complica- niques, so multiple procedures and additional interventional
tions, mainly cholangitis [70, 76]. One randomized prospective techniques (large-balloon dilation, mechanical lithotripsy, chol-
study including 78 patients with primary failure for biliary stone angioscopy-assisted electrohydraulic/laser lithotripsy, or ESWL)
removal who had undergone insertion of a 10-Fr plastic stent may be required [96].
compared two different managements: either systematic stent
exchange every 3 months or stent exchange on demand if
symptoms occurred. Cholangitis was significantly more fre-
quent in the group with on-demand stent exchange (35.9 % vs.
7.7 %; P < 0.03) [81].
Definitive stenting has been suggested for difficult CBDSs in
the elderly with co-morbidities and a limited life expectancy,
given that ERCP in patients aged > 90 years may carry risks of
bleeding, cardiopulmonary events, and mortality that are in-
creased two to three fold (incidence rate ratio [IRR] 2.4, 95 %CI
1.1 – 5.2; IRR 3.7, 95 %CI 1.0 – 13.9; and IRR 3.8, 95 %CI 1.0 –

Common bile duct stones
Not “difficult” “Difficult”
Extraction by sphincterotomy + Predicted failed extraction by sphincterotomy + balloon and/or basket

balloon and/or basket (stone size > 1.5 cm, multiple stones, narrow distal common bile duct,
angled common bile duct)
Limited sphincterotomy* + EPLBD EPLBD of a previous

(same session) sphincterotomy
Failed extraction
Consider mechanical lithotripsy or cholangioscopy-assisted lithotripsy or ESWL
Failed extraction or above Insert temporary plastic stent and refer to

procedures not readily available tertiary care center or consider surgery
▶ Fig. 2 Therapeutic algorithm for management of common bile duct stones when ERCP is selected as the primary treatment. ERCP,
endoscopic retrograde cholangiopancreatography; EPLBD, endoscopic papillary large-balloon dilation (12 – 20 mm); ESWL, extracorporeal
shock wave lithotripsy.
* EPLBD without sphincterotomy suggested in those with coagulopathy.
6.1 Gaining access to the biliary tree and basic dis et al. [98]. In a systematic review (30 studies considered),
treatment for the management of difficult stones the rate of overall adverse events (pancreatitis, bleeding, per-
foration) was lower for endoscopic sphincterotomy with EPLBD
RECO MMENDATION than for endoscopic sphincterotomy alone (8.3 % vs. 12.7 %, OR
ESGE recommends limited sphincterotomy combined 1.60; P < 0.001) [110].
with endoscopic papillary large-balloon dilation as the Based on these data, if large bile duct stones are seen on
first-line approach to remove difficult common bile duct ERCP or cross-sectional imaging, endoscopic sphincterotomy
stones. combined with EPLBD can be used as a first-line approach to fa-
Strong recommendation, high quality evidence. cilitate difficult biliary stone removal [111]. Another possible
indication for performing EPLBD is the treatment of recurrent
CBDSs in individuals with a previous endoscopic sphincterot-
Since the original description in 2003 by Ersoz et al., the use omy because extension of an endoscopic sphincterotomy may
of endoscopic papillary large-balloon dilation (EPLBD) after be associated with a high risk of bleeding and perforation
endoscopic sphincterotomy has become widespread for the [112 – 115] (▶ Fig. 2).
management of difficult CDBSs [97]. Overall, seven RCTs [98 – EPLBD can be performed after either a large [97, 98, 114,
104] and five meta-analyses [105 – 109] have compared the ef- 116 – 121] or limited endoscopic sphincterotomy [99, 120,
ficacy and safety of EPLBD with endoscopic sphincterotomy vs. 122 – 127]. A multicenter retrospective analysis from Asia in-
endoscopic sphincterotomy alone (Table 8 s). cluding 946 patients [120] found large endoscopic sphinctero-
In summary, endoscopic sphincterotomy + EPLBD reduces tomy before EPLBD to be independently associated with an in-
the need for mechanical lithotripsy by about 30 % – 50 % in com- crease in overall adverse events (OR 3.4, 95 %CI 1.8 – 6.6; P <
parison with endoscopic sphincterotomy alone [100, 102, 103], 0.001). The risk of bleeding was higher in the large vs. limited
while the overall rate of successful stone removal remains iden- endoscopic sphincterotomy group (OR 6.2, 95 %CI 2.4 – 16.3;
tical [105 – 108]. The rate of major adverse events, mainly pan- P < 0.001). Perforation was found in only nine patients but it
creatitis, bleeding, and perforation, between the two groups was fatal in three of them. Although only distal CBD stricture
was similar in 6 of 7 RCTs [99 – 104], whereas it was significantly and not size of endoscopic sphincterotomy was an indepen-
lower for EPLBD plus endoscopic sphincterotomy compared dent predictor of perforation, two of the three fatal cases
with endoscopic sphincterotomy alone in the study by Stefani- were associated with a large endoscopic sphincterotomy. A

Guideline
recent literature review suggested performing a small or mid- ure of mechanical lithotripsy. In another more recent retrospec-
sized endoscopic sphincterotomy (1/3 to 1/2 of the distance tive study [132], stone impaction, stone size > 30 mm, and
to the papillary roof) rather than a large one before EPLBD stone to CBD diameter ratio > 1 were significant predictors of
[128]. Nevertheless, in real life most endoscopists decide to mechanical lithotripsy failure.
perform EPLBD when their attempts to remove the stones The most common and feared complications of mechanical
have failed after having already performed a complete endo- lithotripsy are entrapment of the basket, a broken basket, a
scopic sphincterotomy. traction wire fracture, or a broken handle. In a multicenter
EPLBD is performed with a dilation balloon diameter that study by Thomas et al. [135], including 643 patients and using
ranges from 12 to 20 mm. Criteria for deciding the balloon size the TTS technique, the incidence of mechanical lithotripsy-
for EPLBD have not been specifically evaluated in prospective related technical complications was 3.5 %. These complications
studies. In most published studies, the diameter of the distal are usually treated by other types of lithotripsy (OTS, ESWL, or
part of the CBD has been used as the criterion to select the cholangioscopy-assisted lithotripsy), sphincterotomy exten-
size of the balloon [98 – 100, 120, 121]. The risk of perforation sion, or stenting.
increases when the diameter of the balloon is larger than the di-
ameter of the distal part of the CBD and in the presence of a 6.3 Cholangioscopy-assisted lithotripsy
stricture [111].
The vast majority of studies have reported a dilation dura- RECOMMENDATION
tion of 10 – 180 seconds from the disappearance of the waist, ESGE recommends the use of cholangioscopy-assisted
with only three studies reporting a duration in excess of 60 sec- intraluminal lithotripsy (electrohydraulic or laser) as an
onds [110]. One RCT has demonstrated that the rate of compli- effective and safe treatment of difficult bile duct stones.
cations is similar whether EPLBD duration is either 30 or 60 sec- Strong recommendation, moderate quality evidence.
onds [121]. Moreover, a meta-analysis has demonstrated that a
short duration (< 1 minute) vs. a long duration (≥ 1 minute) for
EPLBD does not significantly affect the rate of CBD clearance
[105]. According to these data, the duration of balloon dilation RECOMMENDATION
should be between 30 and 60 seconds from the disappearance ESGE suggests that the type of cholangioscopy and litho-
of the waist [111]. tripsy should depend on local availability and experience.
Weak recommendation, low quality evidence.
6.2 Mechanical lithotripsy
RECO MMENDATION Intraductal shock wave lithotripsy represents an alternative

ESGE recommends mechanical lithotripsy for difficult method to fragment bile stones and allow their removal. There
stones when sphincterotomy plus endoscopic papillary are two methods of generating shock waves in a fluid, using
large-balloon dilation has failed or is inappropriate. either a bipolar probe capable of generating a spark in the case
Strong recommendation, moderate quality evidence. of EHL or a pulsed dye laser system in the case of laser lithotrip-
sy. Both EHL and laser lithotripsy are preferably performed un-
der direct visualization with cholangioscopic guidance.
Mechanical lithotripsy is the simplest available method of There are three major techniques for cholangioscopy: (i) a
fragmenting CBDSs. It consists of entrapping the stone within dual-operator dedicated mother – baby cholangioscopic (MBC)
a reinforced basket and then crushing it by closing the basket system; (ii) a single-operator catheter-based cholangioscopic
against a metal spiral sheath. Two techniques of mechanical li- system (SOC); and (iii) direct use of an ultraslim endoscope or
thotripsy are used: out of the scope (OTS) and through the slim gastroscope (direct peroral cholangioscopy [DPOC]). The
scope (TTS). The OTS technique represents a “salvage” proce- procedures vary with respect to the number of operators, man-
dure to be performed when a standard basket engages a large euverability, image quality, and method of access, resulting in
stone and becomes impacted in the papilla, while the TTS tech- variable success rates. A detailed ESGE technology review on
nique is preferred in elective cases. cholangioscopy techniques was published recently [136]. All
Mechanical lithotripsy has been reported to be an effective three techniques allow laser lithotripsy and EHL.
and safe technique, but multiple sessions may be required. Korrapati et al. have reviewed the efficacy of peroral cholan-
The reported success rates range between 76 % and 91 % and gioscopy for difficult bile duct stones [137]. They estimated an
overall complications from 3 % to 34 % with minimal mortality overall rate of stone clearance of 88 % (95 %CI 85 % – 91 %), with
[129 – 134] (Table 9 s). Three studies have evaluated the pre- SOC showing a high technical success rate. No attempt was
dictors of mechanical lithotripsy failure using multivariate anal- made to compare EHL and laser lithotripsy.
ysis. In a retrospective study [130], stone size was the only vari- Both EHL and laser lithotripsy are effective methods for the
able that affected the success rate. A subsequent prospective removal of difficult bile duct stones, with a 69 % – 81 % clearance
study [129] reported that stone size should be considered to- rate in one session and a 97 % – 100 % clearance rate after multi-
gether with the diameter of the bile duct, suggesting that only ple sessions [138 – 141]. However, no direct comparisons be-
the presence of stone impaction significantly predicted the fail- tween the different methods have been published. In one

recent RCT, patients with bile duct stones > 1 cm were treated endoscopy and surgery. Basically, ERCP can be performed prior
with either laser lithotripsy or conventional therapy (included to (preoperative ERCP), during ongoing (intraoperative ERCP),
EPLBD and mechanical lithotripsy) and achieved one-session or after (post-operative ERCP) cholecystectomy. Preoperative
endoscopic clearance rates of 93 % and 67 %, respectively [142]. ERCP is most commonly practiced, as it is highly effective and
When looking at the rough data of Korrapati et al. [137], the both the endoscopist and the surgeon treat the patient in an
complication rate ranged between 0 % and 25 % (mean 7 %, 95 % environment that is tailored to their own needs and routines.
CI 6 % – 9 %). Cholangitis is the most frequently reported com-
plication [139 – 141]. Pancreatitis is a rare complication, prob- 7.1 The sequential strategy
ably owing to the high percentage of pre-existent sphinctero-
tomies [139]. RECOMMENDATION
Overall, the available data suggest that intraluminal litho- ESGE recommends performing a laparoscopic cholecyst-
tripsy is an effective and safe method to treat difficult biliary ectomy within 2 weeks from ERCP in patients treated for
stones (Table 10 s; ▶ Fig. 2), but there are no data supporting choledocholithiasis to reduce the conversion rate and the
the superiority of one method over another. risk of recurrent biliary events.
Strong recommendation, moderate quality evidence.
6.4 Extracorporeal shock wave lithotripsy
RECO MMENDATION Laparoscopic cholecystectomy represents the standard

ESGE suggests considering extracorporeal shock wave treatment for patients with CBDSs and gallbladder stones fol-
lithotripsy when conventional techniques have failed to lowing endoscopic CDBS clearance. A Cochrane review in 2007
achieve bile duct clearance and the intraluminal lithotrip- [154], which considered five RCTs involving 662 patients treat-
sy techniques are not available. ed for choledocholithiasis with cholecystolithiasis, revealed an
Weak recommendation, low quality evidence. advantage of cholecystectomy. Over a follow-up time varying
from 17 months to more than 5 years, mortality was higher in
the wait-and-see group compared with the cholecystectomy
ESWL uses electrohydraulic or electromagnetic energy to group (14.1 % vs. 7.9 %; RR 1.78, 95 %CI 1.15 – 2.75) and the dif-
generate shock waves that then travel through the soft tissues ference persisted when only patients at high surgical risk were
of the body to fragment CBDSs [143]. considered.
ESWL is a complex and technically demanding procedure. A Similarly, endoscopic sphincterotomy followed by “wait and
nasobiliary drain is inserted to allow fluoroscopic identification see” also resulted in a higher risk of biliary events, such as cho-
and targeting of CBDSs and to perform continuous irrigation of langitis, pancreatitis, jaundice, and biliary colic, as well as a
the bile duct with saline during ESWL. In addition, multiple higher risk for repeated biliary intervention (i. e. ERCP or percu-
ESWL sessions and subsequent ERCP procedures to extract taneous procedure): 35 % of the patients managed with endo-
stone fragments are required. scopic sphincterotomy followed by “wait and see” eventually
Ductal clearance rates of 70 % – 90 % have been reported underwent rescue cholecystectomy. The outcome of rescue
with ESWL [52, 144 – 150]. cholecystectomy in patients with an ASA > 3 was not signifi-
Several controlled trials have compared ESWL with EHL or la- cantly different compared to elective cholecystectomy; how-
ser lithotripsy for stone disruption. These studies suggest that ever, patients unfit for surgery (i. e. ASA 4 and 5) were excluded
the efficacy of final duct clearance with laser lithotripsy is su- in three of the five selected RCTs [155 – 157]. In the study by
perior to that of ESWL (83 % – 97 % vs. 53 % – 73 %) [146, 151], Suc et al. [158], 20 % of the included patients were classified as
while it is similar for EHL and ESWL (74 % vs. 78.5 %) [145]. ASA 3 – 4, and mortality was not significantly different between
ESWL-related adverse events range from 9 % to 35.7 %, in- the two groups in the intention-to-treat analysis (3.1 vs. 0.9 %).
cluding mostly cholangitis and pancreatitis [143, 145, 146, Also, in the RCT by Targarona et al. [159], mortality was not sig-
152, 153]. Minor side effects such as pain, local hematoma for- nificantly different between the groups but, in the multivariate
mation, and microhematuria are common. analysis, age, and not surgical risk, was an independent predic-
tor of mortality.
Laparoscopic cholecystectomy after ERCP with endoscopic
7 Endoscopic CBDS management sphincterotomy is more difficult and when compared to stand-
ard laparoscopic cholecystectomy is mostly associated with a
and surgery higher conversion rate and a higher rate of recurrent biliary
ERCP with stone clearance represents the primary and defini- events [157, 160, 161]. In this way, the timing of cholecystect-
tive treatment in patients with CBDSs and previous cholecys- omy performance after ERCP is a critical issue [155, 157, 162 –
tectomy. In patients with CBDSs and in situ gallbladder, both 167] (Table 11 s). The timing of cholecystectomy may be de-
the management of CBDSs and gallbladder removal should be fined as early, delayed, or on demand, but definitions of “early”
considered. or “delayed” differ among the studies. In general, with the ex-
When ERCP is the selected technique to treat CBDSs, differ- ception of the study by Donkervoort et al. [168], where the tim-
ent options are available with regards to the sequencing of ing of cholecystectomy did not affect the outcomes, conversion

Guideline
rate results are lower in the “early group” in all studies (4 % – 23 % Conventional ERCP can be performed intraoperatively, but it
vs. 8 % – 55 %); recurrent biliary events are lower when the la- exposes the patient to similar risks to a conventional ERCP per-
paroscopic cholecystectomy is performed “early” vs. “delayed formed preoperatively, albeit it is performed during the same
or on demand” (2 % – 10 % vs. 24 % – 47 %) [155, 157, 162 – 167]. anesthesia [176, 177]. Conversely, intraoperative ERCP with
Overall, data are in favor of “early” laparoscopic cholecystect- rendezvous cannulation offers the advantages of being a sin-
omy, but the exact timing remains controversial; despite this, gle-stage procedure and decreasing the risk of post-ERCP pan-
waiting no longer than 2 weeks to perform laparoscopic chole- creatitis. Although each individual clinical trial is underpowered
cystectomy after ERCP seems to be advisable. to validate this, there are six RCTs [176, 178 – 182] and approxi-
In patients with acute biliary pancreatitis (ABP) and in situ mately 15 observational studies pointing in the same direction
gallbladder, cholecystectomy is recommended to avoid a recur- [177, 183 – 197] (Tables 12 s and 13 s). These results have been
rence of pancreatitis. Some of these patients may have pre- confirmed by six recent meta-analyses [198 – 202]. The most
viously undergone ERCP and endoscopic sphincterotomy. The recent of these, comparing intraoperative rendezvous ERCP
timing of cholecystectomy in mild ABP has been examined in with sequential management, mainly laparoscopic chole-
two RCTs that randomized patients either to cholecystectomy cystectomy and preoperative ERCP, reported equal efficacy in
within 48 hours of admission vs. after resolution of abdominal terms of stone clearance rate (93 % vs. 95 %), but a significantly
pain and normalizing trend of laboratory enzymes (n = 50) lower rate of morbidity (6 % vs. 11 %; OR 0.54, 95 %CI 0.31 –
[169], or to cholecystectomy during the same admission vs. 4 0.96; P = 0.03), including post-ERCP pancreatitis (0.6 % vs.
weeks later (n = 266) [170]. Both studies concluded in favor of 4.4 %; OR 0.19, 95 %CI 0.06 – 0.67; P = 0.01) and length of hospi-
early cholecystectomy because it prevents recurrent gallstone- tal stay in the intraoperative ERCP group [202]. In addition, the
related complications (one study), shortens hospitalization Swedish GallRiks registry, comprising 12 718 ERCP procedures,
(one study), and is equally safe (both studies). Similar conclu- demonstrated a substantial 50 % risk reduction in post-ERCP
sions were reached in a meta-analysis (eight cohort studies pancreatitis (3.6 % vs. 2.2 %; OR 0.5, 95 %CI 0.2 – 0.9; P = 0.002)
and one RCT, 998 patients) [171]. For severe ABP, data are lim- when rendezvous cannulation was practiced [203].
ited and, based on observational studies [172, 173], it is recom- Intraoperative rendezvous ERCP does however carry logisti-
mended that cholecystectomy is performed once peripancrea- cal problems related to the prolonged surgical time and the
tic collections and local complications have resolved, generally need to perform ERCP in an environment that is not adapted
beyond 6 weeks, to minimize the risk of infection in the peri- for endoscopy [180, 182,189,191,204]. Failure to pass the
pancreatic collection. guidewire along a narrow cystic duct or papilla is reported in
In patients who do not undergo cholecystectomy following about 8 % of cases (Table 12 s); if this happens, the endoscopist
ABP, endoscopic biliary sphincterotomy reduces biliary events, must rely on conventional cannulation techniques and their
in particular pancreatitis, during follow-up [171, 174, 175]. The associated risks.
most recent retrospective study (1119 patients) found that re-
current pancreatitis developed in 8.2 % vs. 17.1 % of patients 7.3 Surgical treatment of CBDSs
with their gallbladder left in situ after ABP who had ERCP vs.
no ERCP, respectively [174]. However, the gallbladder should RECOMMENDATION
be left in situ only in patients who are unfit for surgery as a ESGE suggests that, in patients undergoing laparoscopic
meta-analysis (five RCTs, 662 patients) has shown that endo- cholecystectomy, transcystic or transductal exploration
scopic CBD clearance alone is inferior to prophylactic cholecys- of the common bile duct is a safe and effective technique
tectomy associated with CBD clearance in terms of mortality for common bile duct stone clearance. The recommenda-
and recurrent biliary events [154]. tion takes into account that management is dependent
on local expertise and resources.
7.2 Intraoperative ERCP Weak recommendation, moderate quality evidence.
RECO MMENDATION
ESGE suggests considering intraoperative rendezvous The surgical treatment of CBDSs can be performed during
ERCP in patients with common bile duct stones under- both laparoscopic and open cholecystectomy. It offers the valu-
going cholecystectomy. able opportunity to definitively treat patients with combined
Weak recommendation, moderate quality evidence. cholecystolithiasis and choledocholithiasis in a one-stage pro-
cedure.
Several studies have compared laparoscopic bile duct ex-
Intraoperative ERCP can be performed during laparoscopic ploration during laparoscopic cholecystectomy with pre- or
cholecystectomy when an IOC demonstrates the presence of postoperative ERCP and have demonstrated no significant dif-
CBDSs; alternatively, it can be planned either as a one-stage ap- ferences in clinical outcomes [205 – 207]. However, one-stage
proach in the treatment of combined cholecysto-choledocholi- procedures, such as laparoscopic CBD exploration or combined
thiasis or after the failure of a preoperative endoscopic attempt endo-laparoscopic approaches, usually result in a shorter hos-
at CBDS clearance. pital stay [208 – 217]. Moreover, a recent meta-analysis has
demonstrated that the one-stage laparoscopic procedure has

a higher success rate than the sequential endo-laparoscopic ap- 8.2 Timing of ERCP in acute cholangitis
proach [218].
It is of note that the results of surgical treatment of CBDSs,
RECOMMENDATION
which are generally excellent in published reports, usually origi-
ESGE recommends the following timing for biliary drain-
nate from laparoscopic centers of excellence, and there are
age, preferably endoscopic, in patients with acute cho-
hardly any data on outcomes by less experienced surgeons.
langitis, classified according to the 2018 Tokyo Guide-
Moreover, there is a trend over the last decades that the use of
lines:
endoscopic management is increasing and surgical trainees are
▪ severe, as soon as possible and within 12 hours for pa-
not gaining adequate experience in CBD exploration [219].
tients with septic shock
▪ moderate, within 48 – 72 hours
8 Special situations ▪ mild, elective.
Strong recommendation, low quality evidence.
Acute cholangitis and ABP may complicate CBDSs, resulting in a
more difficult therapeutic approach. Moreover, CBDSs may oc-
cur in special clinical settings, such as in pregnant women. The Twelve studies (18 206 patients), all retrospective, have an-
endoscopic management of ABP was the object of the ESGE alyzed the relationship between the timing of biliary drainage
Guideline on endoscopic treatment of necrotizing pancreatitis and different outcomes (Table 14 s). An international study
[220]. from 28 intensive care units published in 2016 included 260 pa-
tients with septic shock (defined as hypotension requiring vaso-
8.1 Acute cholangitis pressors plus several other criteria); it found that waiting longer
The majority of patients with gallstone cholangitis have mild- than 12 hours from the onset of shock to successful biliary
to-moderate disease that usually responds to antibiotic ther- drainage was associated with higher in-hospital mortality (OR
apy. However, 15 % – 30 % of patients have severe disease that 3.4, 95 %CI 1.12 – 10.31) [223]. Overall, in-hospital mortality
needs to be handled with urgent biliary decompression [221]. was 37 % and median time to biliary drainage was 12 hours,
Identification and stratification of cholangitis severity is fun- with 10 % of patients having drainage after 48 hours [223].
damental to selecting the appropriate treatment. The other 11 studies were not restricted to patients with dis-
ease that was so severe [224 – 234]; they revealed, among the
studies that analyzed the specific matter, that: mortality was
RECO MMENDATION
associated with delayed ERCP in two of four studies
ESGE recommends using the 2018 revision of the Tokyo
[223, 233]; organ failure (alone or as part of a composite index)
Guidelines to classify the severity of acute cholangitis.
was associated with delayed ERCP in three of five studies
Strong recommendation, low quality evidence.
[226, 227,230]; length of hospital stay was associated with the
timing of ERCP in seven of eight studies [225, 227, 229, 230,
The 2013 revision of the Tokyo Guidelines [221], recently 232 – 234]; hospitalization costs were higher when ERCP was
confirmed by the 2018 revision [222], classifies acute cholangi- delayed in both studies that analyzed that association [230,
tis as: 233].
▪ severe, dysfunction of at least one of the following systems:
cardiovascular, neurological, respiratory, renal, hepatic, or RECOMMENDATION
hematological system (specific criteria are stated for each ESGE recommends other biliary drainage modalities (per-
item) cutaneous, surgical) in patients with acute cholangitis
▪ moderate, any of the following: white blood cell count due to common bile duct stones when ERCP is not feasi-
> 12 000 or < 4000 /mm3, fever ≥ 39 °C, age ≥ 75 years, total ble/successful within the recommended timeframes.
bilirubin ≥ 5 mg/dL, or hypoalbuminemia Strong recommendation, low quality evidence.
▪ mild, no criteria of moderate/severe cholangitis.
Failure of biliary drainage is a strong determinant of mortal-
Companion mobile applications of the 2018 Tokyo Guidelines ity, particularly in patients with severe cholangitis. For example,
allow easy assessment of the severity of acute cholangitis in the abovementioned study of patients with septic shock
(http://www.jshbps.jp/modules/en/index.php?content_id=47 [223], 40 of 42 patients with failed biliary drainage (95.3 %)
Accessed 30 January 2019). died as compared with 55 of 213 patients with successful biliary
drainage (25.8 %). In that study, biliary drainage was achieved
by ERCP, percutaneous transhepatic biliary drainage (PTBD),
and surgery in 91, 90, and 34 patients, respectively. Similarly,
in a study not restricted to patients with severe disease [225],
three of six patients with failed biliary drainage (50 %) died as
compared with two of 321 patients with successful biliary
drainage (0.6 %).

Guideline
8.3 Management of CBDSs in pregnant woman Competing interests
RECO MMENDATION A. Anderloni has provided consultancy to Boston Scientific (2016 –

ESGE recommends that therapeutic ERCP is a safe and ef- 2018) and Olympus (2018). M. Barthet’s department received a re-
fective procedure in pregnant women, provided that it is search grant (2016 – 2018). D. Domagk’s department has received
workshop, consultancy, and speaker’s fees from Hitachi (2016 to
performed by experienced endoscopists and the radia-
present), and speaker’s fees and symposia support from Dr. Falk
tion exposure to the fetus is kept as low as possible. Foundation and Olympus (both 2015 to present). I. Hritz has provid-
Strong recommendation, moderate quality of evidence. ed consultancy and training for Olympus (2017 to present) and con-
sultancy to Pentax Medical (2018 to present). G. Paspatis has receiv-
ed sponsorship for invited speeches from Boston Scientific (2014 –
According to six retrospective studies (144 patients), ERCP 2018). T. Ponchon has been on the advisory board of Olympus
(2018) and his department has received clinical research funding
in pregnant women seems to be a relatively safe examination
from Fujifilm (2018). J. E. van Hooft received lecture fees from Med-
throughout the whole gestation [235 – 240]. ERCP should only tronics (2014 – 2015) and provided consultancy to Boston Scientific
be performed for therapeutic purposes as EUS and MRCP are
(2014 – 2016), her department has received research grants from
highly accurate for the diagnosis of biliary obstruction. Further- Cook Medical (2014 – 2018) and Abbott (2014 – 2017). E. J. Williams
more, it should be performed by experienced endoscopists as was chair of the British Society of Gastroenterology writing group for
guidelines on common bile duct stones (2014 – 2017). L. Aabakken,
radiation dose, as well as the overall complication rate, decrea-
P. Ah-Soune, M. Arvanitakis, J.-M. Dumonceau, J.-F. Gigot, G. Kar-
ses with the experience of the endoscopist [241 – 244]. amanolis, A. Laghi, G. Manes, A. Mariani, K. Paraskeva, J. Pohl,
With respect to the potential harm related to X-rays, ERCP is F. Swahn, R. ter Steege, A. Tringali, and A. Vezakis have no compet-
best carried out during the second trimester of pregnancy; during interests.
ing the first trimester, the phase of organogenesis, the fetus is
especially sensitive to radiation and, during the third trimester,
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Guideline

Endoscopic management of common bile duct stones:

Institutions 18 Center for Digestive Diseases, Karolinska University

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

PUBLI C AT I ON IN FOR MAT I ON

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

RECO MMENDATION RECOMMENDATION

Patients at risk of having CBDSs, such as patients with gall-

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Symptomatic gallstone disease

Low likelihood of CBDS Intermediate likelihood of CBDS High likelihood of CBDS

Perform EUS / MRCP

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Not “difficult” “Difficult”

Extraction by sphincterotomy + Predicted failed extraction by sphincterotomy + balloon and/or basket

Limited sphincterotomy* + EPLBD EPLBD of a previous

Consider mechanical lithotripsy or cholangioscopy-assisted lithotripsy or ESWL

Failed extraction or above Insert temporary plastic stent and refer to

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

RECO MMENDATION Intraductal shock wave lithotripsy represents an alternative

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

RECO MMENDATION Laparoscopic cholecystectomy represents the standard

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

8.3 Management of CBDSs in pregnant woman Competing interests

RECO MMENDATION A. Anderloni has provided consultancy to Boston Scientific (2016 –

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

Manes Gianpiero et al. Endoscopic management of CBD stones … Endoscopy

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