Journal of

Clinical Medicine

Systematic Review
Assessment of Effectiveness and Safety of Aspiration-Assisted
Nephrostomic Access Sheaths in PCNL and Intrarenal Pressures
Evaluation: A Systematic Review of the Literature
Marco Nizzardo 1 , Giancarlo Albo 1,2 , Francesco Ripa 3 , Ester Zino 1 , Elisa De Lorenzis 1 , Luca Boeri 1 ,
Fabrizio Longo 1 , Emanuele Montanari 1,2 and Stefano Paolo Zanetti 1, *

1 Department of Urology, IRCCS Foundation Ca’ Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy
2 Department of Clinical Sciences and Community Health, University of Milan, 20122 Milan, Italy
3 Department of Urology, Whittington Health NHS Trust, London N19 5NF, UK
* Correspondence: stefano.zanetti@policlinico.mi.it

Abstract: Background: Different suction-assisted nephrostomic sheaths have been developed for
percutaneous nephrolithotomy (PCNL). Objectives: (1) To examine PCNL techniques performed
with different aspiration-assisted sheaths (Clear Petra® sheath, Superperc, SuperminiPCNL, and a
miniPCNL patented sheath), with specific regard to effectiveness and safety outcomes in adult and
paediatric patients; (2) to extrapolate intrarenal pressure (IRP) data during these procedures. Methods:
A systematic literature search was performed in accordance with PRISMA guidelines. Relevant
articles up to 8 February 2024 were included. Results: Twenty-five studies were selected, thirteen
retrospective and twelve prospective. The use of four different aspirating sheaths for miniPCNL was
reported: Clear Petra® sheath, Superperc, SuperminiPCNL, and a miniPCNL patented sheath. Stone
free rates (SFRs) across techniques ranged from 71.3% to 100%, and complication rates from 1.5% to
38.9%. Infectious complication rates varied from 0 to 27.8% and bleeding complication rates from 0
to 8.9%. Most complications were low grade ones. The trend among studies comparing aspiration-
Citation: Nizzardo, M.; Albo, G.; Ripa, and non-aspiration-assisted miniPCNL was towards equivalent or better SFRs and lower overall
F.; Zino, E.; De Lorenzis, E.; Boeri, L.; infectious and bleeding complication rates in suction techniques. Operation time was consistently
Longo, F.; Montanari, E.; Zanetti, S.P.
lower in suction procedures, with a mean shortening of the procedural time of 19 min. Seven
Assessment of Effectiveness and
studies reported IRP values during suction miniPCNL. Two studies reported satisfactory SFRs and
Safety of Aspiration-Assisted
adequate safety profiles in paediatric patient cohorts. Conclusions: MiniPCNL with aspirating
Nephrostomic Access Sheaths in
sheaths appears to be safe and effective in both adult and paediatric patients. A trend towards a
PCNL and Intrarenal Pressures
Evaluation: A Systematic Review of
reduction of overall infectious and bleeding complications with respect to non-suction procedures is
the Literature. J. Clin. Med. 2024, 13, evident, with comparable or better SFRs and consistently shorter operative times. The IRP profile
2558. https://doi.org/10.3390/ seems to be safe with the aid of aspirating sheaths. However, high quality evidence on this topic is
jcm13092558 still lacking.

Academic Editor: Javier C. Angulo

Keywords: percutaneous nephrolithotomy; aspiration-assisted miniPCNL; suction PCNL; intrarenal
Received: 24 March 2024 pressure
Revised: 18 April 2024
Accepted: 24 April 2024
Published: 26 April 2024

1. Introduction
Percutaneous nephrolithotomy (PCNL) is the established method for treating large
Copyright: © 2024 by the authors.
kidney stones [1], but concerns arise due to complications such as postoperative infections
Licensee MDPI, Basel, Switzerland. and bleeding [2]. To mitigate the associated morbidity, miniaturised PCNL systems have
This article is an open access article been developed [3–6]. However, miniaturised systems are not devoid of limitations, includ-
distributed under the terms and ing challenges in stone fragment asportation, reduced visibility, prolonged operative times
conditions of the Creative Commons (OTs), and elevated intrarenal pressures (IRPs) [7,8].
Attribution (CC BY) license (https:// An excessive IRP during PCNL might result in pyelovenous backflow of irrigation
creativecommons.org/licenses/by/ fluid and bacteria colonising the stones [9], leading to infectious complications such as
4.0/). fever and sepsis [10], as well as fluid overload, electrolyte imbalance, and cardiovascular

J. Clin. Med. 2024, 13, 2558. https://doi.org/10.3390/jcm13092558 https://www.mdpi.com/journal/jcm

J. Clin. Med. 2024, 13, 2558 2 of 21

instability. Therefore, the development of implemented systems able to monitor and reduce
IRP during PCNL is of paramount importance.
To address these issues, miniPCNL systems equipped with aspirating sheaths have
been introduced. The real-time suction of irrigation fluid, stone fragments, and blood
during the procedure aims to reduce IRP, enhance visibility, and expedite the procedure.
Different aspiration-assisted nephrostomic access sheaths have been developed and are
nowadays available on the market.
Our objective is to systematically examine PCNL techniques performed by means of
the different aspiration-assisted nephrostomic access sheaths described in the literature
and currently applied in clinical practice, with specific regard to effectiveness and safety
outcomes both in adult and paediatric patients.
The secondary objective is to extrapolate IRP data during aspiration-assisted miniPCNL
from the included studies that addressed this topic.

2. Materials and Methods

2.1. The Literature Search
We conducted a systematic review to identify studies assessing the impact on stone-
free rates (SFRs) and complication rates associated with various nephrostomic access
sheaths equipped with aspiration systems used in percutaneous nephrolithotomy (PCNL).
A systematic literature search was carried out on 8 February 2024, utilizing COCHRANE,
Google Scholar, EMBASE, PubMed, and Scopus databases, in accordance with the Preferred
Reporting of Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The search
employed the following terms and Boolean operators: (“suction” OR “active suction”
OR “suction device” OR “suction sheath” OR “clearpetra” OR “vacuum assisted”) AND
(“PCNL” OR “mini-PCNL” OR “miniaturized PCNL” OR “percutaneous nephrolithotomy”
OR “supermini-PCNL” OR “SMP” OR “vacuum assisted mini PCNL”) AND (“stone free”
OR “stone clearance” OR “SFR” OR “complications” OR “bleeding” OR “infection”).

2.2. Screening Criteria and Study Selection

We included exclusively full-text English papers, encompassing studies involving
both paediatric and adult populations. Inclusion criteria were studies reporting on clinical
outcomes of aspiration systems or sheaths used during PCNLs, case series, comparative
studies, RCTs, and retrospective or prospective studies. Exclusions comprised duplicated
studies, case reports, letters to the editor, editorials, systematic reviews, meta-analyses, and
conference abstracts. In vitro studies, studies including patients treated with ECIRS, or
patients with congenital or acquired urinary system abnormalities or transplanted kidneys
were also excluded.
Two independent authors (M.N. and F.R.) screened all selected papers. Discrepancies
were resolved by a third field-expert author not involved in the primary selection process
(SPZ). The list of articles was expanded by incorporating noteworthy manuscripts that
were not initially found in this search. This augmentation was achieved through cross-
referencing the reference lists from the selected articles and previous reviews. Publications
pertinent to the subject were subsequently retrieved and subjected to appraisal.

2.3. Evidence Analysis

After selecting the relevant study and analysing the reported data, we employed the
PICO protocol as follows:
- Population: patients undergoing percutaneous nephrolithotomy (PCNL) for stone
treatment.
- Intervention: PCNL performed by means of suction devices applied to the nephros-
tomic access sheath.
- Comparison: aspiration-assisted PCNL procedures were compared in terms of effec-
tiveness and safety outcomes with PCNL procedures without aspiration as reported
in the literature.
J. Clin. Med. 2024, 13, 2558 3 of 21

- Outcomes:
Effectiveness outcomes: final stone-free rate (SFR);
Safety outcomes: complication rate (infectious and bleeding complications); operative
time (OT); intrarenal pressure (IRP).

3. Results
3.1. The Literature Screening
The literature search initially yielded 594 studies. Following the removal of 71 du-
plicates, 523 studies underwent screening based on their title and abstract. Among these,
452 papers were excluded as they were deemed irrelevant to the purpose of this review.
One additional study was excluded due to unavailability. The remaining 70 studies under-
went further assessment for eligibility. Of these, 45 were excluded from the final selection
for the following reasons: 11 were systematic reviews or meta-analyses, 8 did not focus
on the relevant topic or outcomes, 8 were abstracts only, 8 represented ongoing trials,
7 described systems utilising aspiration through the working channel of the nephroscope
instead of an aspirating sheath, 1 study did not specify the aspiration system used, 1 was a
letter to the editor, and 1 study was not in English. After this selection process, 25 studies
were included in the systematic review.
A summarised diagram illustrating the literature search process is presented in Figure 1.

Figure 1. Diagram illustrating the literature search.

J. Clin. Med. 2024, 13, 2558 4 of 21

3.2. Evidence Summary

Among the 25 studies included in this review, 13 were retrospective [11–23] and
12 were prospective [24–35]; 6 of the latter were randomised trials [25,26,29,31,32,35].
A total of 11 papers analysed the use of the Clear Petra® (Well Lead Medical Co., Ltd.,
Guangzhou, China) nephrostomic access sheath [12–18,22,26,29,31]; 3 articles focused on
the Superperc technique performed by means of the Shah sheath [25,28,30]; 1 article de-
scribed a single series of procedures performed with both the above-mentioned devices [33];
5 articles explored the use of SuperminiPCNL (SMP) [19,20,23,24,34]; 5 articles reported
outcomes of a Chinese-patented miniPCNL suctioning sheath [11,21,27,32,35]. Table 1
reports the above mentioned studies and their main characteristics.

3.3. Exploration of Aspiration-Assisted Nephrostomic Access Sheaths for PCNL

In our review, a diverse array of aspiration-assisted systems for PCNL has been
identified, ranging from the most employed to less common systems. As previously
mentioned, only the systems integrating suction in the nephrostomic sheath have been
included in the current review. Systems in which aspiration is vehiculated through other
ways, such as the operative channel of the nephroscope or the lithotripsy probe, will not be
discussed in this dissertation.
Therefore, we will furnish a comprehensive overview of the available aspiration-
assisted nephrostomic access sheaths employed for PCNL. Despite their shared characteristic
of integrating aspiration with the aim of reducing intrarenal pressure and enhancing visibility,
these devices exhibit unique features in terms of functionality and structural design.
There is no clear indication on the size and characteristics of the stones to be treated
with aspiration-assisted PCNL. The total size of the stones treated in the different studies is
reported in Table 1. Due to the heterogeneity in reporting stone size among the different
studies (either maximum diameter, surface area, or volume), this parameter, albeit of
paramount clinical importance, is not comparable and therefore will not be included in the
results section.

3.3.1. Clear Petra System

Of the 25 articles included, 11 focus on the Clear Petra system [12–18,22,26,29,31]. The
Clear Petra set is composed of a nephrostomic access sheath with its stylet, a connection
tube, and a stone collection bottle. The nephrostomic sheath is externally plugged by a
cap with a central hole to prevent the medium from flowing out when the nephroscope
is inserted. The sheath is equipped with a lateral oblique arm that is connected via the
connection tube to the stone collection bottle. The bottle is in turn connected to the
aspiration system. Stone powder and irrigation fluid are continuously aspirated during
lithotripsy in the space between the scope and the sheath, while larger fragments are
retrieved by withdrawing the nephroscope inside the sheath as far as the opening of
the lateral arm, which is wide enough to allow the passage of fragments as large as
7–8 mm in maximum diameter. Aspirated stone fragments are collected in the plastic bottle
interposed between the sheath and the aspiration system. The lateral arm of the sheath, the
connection tube, and the bottle are made of transparent material, allowing the endourologist
to monitor the egress of stone fragments and to examine the colour of the irrigation fluid,
thus promptly detecting obstructions and bleeding. The aspiration pressure is not fixed but
can be regulated by means of a valve positioned on the stone collection bottle. Moreover, an
on-demand aspiration enhancement can be obtained by the surgeon by finger plugging a
small opening on the lateral arm of the sheath. According to the different studies, irrigation
is provided either by gravity [12,14,22] or via a mechanical pump [13,26,29,31]. Lithotripsy
might be performed via a Holmium:YAG laser [12–14,22,26,29] or via both pneumatic and
laser lithotripsy [31]. The Clear Petra sheath size can range from 12 Fr to 28 Fr and it
is available in different lengths ranging from 13 to 21 cm. In the studies analysed, the
employed sheath size was from 14 to 20 Fr.
J. Clin. Med. 2024, 13, 2558 5 of 21

Table 1. Studies included in the review with their main characteristics.

Access Type of Operative Compli- Infectious Infectious Final

Authors Nature of the Aim of the Total Stone Suction IRP Complication Compli- Bleeding Bleeding SFR
Population Sheath (mmHg) Time cation Complica- SFR Method
(Year) Study Study Size * Size Sheath/ (min) Rate (%) Notes cation tion Notes Rate (%) Notes (%)
Device Rate (%)
Grade I
Grade I Grade I (2.1%),
Validation and (7.7%), (1.7%), grade II
investigation of 2200 grade II
Pozzi E. et al. 107 grade II (3.5%),
Retrospective predictors of Adult (1000–4600) 16 ClearPetra 28.3 (15.7%), 15.6 7.6 76.3 CT scan
(2022) [12] (80–140) (13.6%), grade IIIa
trifecta in mm3 grade grade IIIa (1%),
vmPCNL IIIa–IIIb (0.3%) grade IIIb
(4.9%)
(1%)
Comparison of
SFR and Grade I
complications (5.3%), CT
Szczesniewski grade II Fever (7%),
Retrospective of miniPCNL 385 ± 250 16 95 ± 41 14.1 10.5 sepsis 0 71.9 scan/US/
JJ. et al. Adult mm2 ClearPetra KUB
(2023) [13] with standard (5.3%),
grade III (3.5%) X-ray
access sheath
versus suction (3.5%)
devices
Comparison of
outcomes of Grade I-II
Lievore E. minimally 1700 (17.3%),
et al. (2021) Retrospective (1300–3600) 16 90 24 grade 7.7 Not 4.8 89.4 US/CT
invasive PCNL Adult ClearPetra (75–125) specified Not specified
scan
[14] (MIP) vs. mm3 IIIa–IIIb
aspiration- (6.7%)
assisted PCNL
Investigation of
safety and
efficacy of 1 case of
Prospective miniPCNL with bleeding
Lai D. et al. 23.4 ± 7.3 20 56.3 ± 15.8 13.2 Fever 2.6 requiring 94.4 CT scan
vacuum- Adult mm ClearPetra 19.83 Grade II (>38.5 → C)
(2020) [26] randomized
assisted sheath blood
in obstructive transfusion
calculous
pyonephrosis
Safety and
feasibility of
semi-closed-
Gallioli A. circuit Grade I-II 6 US and
Retrospective vacuum- 32 (22–46) 14–16 128 38.9 27.8 Fever 0 81.3
et al. (2020) Paediatric ClearPetra (99–167) cases, grade KUB
[18] assisted mm IIIa 1 case X-ray
miniPCNL
(vmPCNL) in
paediatric
patients.
J. Clin. Med. 2024, 13, 2558 6 of 21

Table 1. Cont.

Access Type of Operative Compli- Infectious Infectious Final

Authors Nature of the Aim of the Total Stone Suction IRP Complication Compli- Bleeding Bleeding SFR
Population Sheath (mmHg) Time cation Complica- SFR Method
(Year) Study Study Size * Size Sheath/ (min) Rate (%) Notes cation tion Notes Rate (%) Notes (%)
Device Rate (%)
15 cases of
Assessment of fever, 2 cases
of UTI, 2
safety and cases of 2 cases of
27.8 ± 6.3 bleeding
Lai D. et al. Prospective efficacy of a mm, blood Fever (8%), Not
vacuum- Adult 18 ClearPetra 10.3 ± 4.3 32.4 ± 9.6 16 transfusion, 10.7 2.7 requiring 97.3
(2020) [29] Case Control 676.1 ± 22.2 UTI (2.7%) specified
assisted access mm2 and 1 case of blood
sheath in collecting transfusion
miniPCNL system
perforation
1 case of
bleeding
requiring
To describe Grade I bladder
vacuum- (11.4%), irrigation;
assisted grade II 2 cases of
Zanetti S.P. miniPCNL and 1920
evaluate its (1000–3100) 9.7 ± 4.4 90 (8.2%), bleeding US/CT
et al. (2020) Retrospective Adult 16 ClearPetra mmHg (71–120) 25.4 grade IIIa 7.4 Fever 2.4 requiring 71.3
outcomes and scan
[22] mm3 (3.3%), angioemboli-
intrarenal
pressures grade IIIb sation, of
during surgery (2.5%) which
1 requiring
blood
transfusion
Comparison of
safety and 2 cases of
effectiveness of Grade I Fever not bleeding
Xu G. et al. Prospective conventional vs. 64.3 ±
Adult 42 ± 10 mm 20 ClearPetra 8.6 ± 2.0 13.2 (6.6%), grade 6.6 requiring 6.6 requiring 86.7 CT scan
(2020) [31] randomized suction sheath 29.1
II (6.6%) antibiotics blood
in miniPCNL transfusion
for staghorn
stones
Description of
Double- 50.2 KUB
Wu Z.H. et al. Retrospective double-sheath Adult 36.3 (26–71) 20 sheath 1.5 1 case of low 0 0 90.8 X-ray and
(2022) [15] vacuum suction mm (39–83) fever US
ClearPetra
miniPCNL
Comparison of
double suction
sheath 32.60 ± 8.91 Double- 35.78 ± 1 case of KUB
Wu Z.H. et al. Retrospective 20 1.6 2.9 0 93.8 X-ray and
(2021) [17] miniPCNL vs. Adult mm sheath 7.77 fever (>38
ClearPetra → C) US
vacuum-
assisted
miniPCNL
J. Clin. Med. 2024, 13, 2558 7 of 21

Table 1. Cont.

Access Type of Operative Compli- Infectious Infectious Final

Authors Nature of the Aim of the Total Stone Suction IRP Complication Compli- Bleeding Bleeding SFR
Population Sheath (mmHg) Time cation Complica- SFR Method
(Year) Study Study Size * Size Sheath/ (min) Rate (%) Notes cation tion Notes Rate (%) Notes (%)
Device Rate (%)
Comparison of
double suction
Tuoheti K.B. sheath Double- KUB
Retrospective miniPCNL vs. 32.49 ± 8.71 20 41.97 ± 2.9 2.9 0 92.6 X-ray and
et al. (2023) Adult mm sheath 8.24 Fever only
[16] conventional ClearPetra US
miniPCNL for
large kidney
stones
Report of safety
and efficacy of UTI
Shah D. et al. Prospective miniPCNL with 18.32 ± 6.37 Shah 39.85 ± treated
suction Adult mm 18 sheath or 20.52 5.5 Grade II 5.5 with 0 100 CT/X-ray
(2020) [33] single arm ClearPetra
combined with antibiotics
thulium fibre
laser (TFL).
Description of
Superperc
Shah K. et al. Prospective Adult and 19.1 ± 7.1 Shah 40.98 ± Not
technique and mm na 12.09 5.7 Fever only 5.7 0 96.1 specified
(2017) [28] observational paediatric sheath
assessment of
feasibility
Comparison of
miniPCNL with UTI
Patil A. et al. Prospective, not trilogy 22.04 ± 9.69 Shah 28.63 ± UTI requiring
Adult 18 6.7 6.7 requiring 0 100 CT scan
(2022) [30] randomized lithotripsy vs. mm sheath 18.56 antibiotics
antibiotics
Superperc with
TFL
Comparison of 1 case of in-
infectious Bleeding traoperative
complications (2.5%), bleeding
Pathak N. Prospective and other 16.7 26.5 fever (2.5%), requiring
(11.95–20) 18 Shah 10 5 Fever and 2.5 97.5 CT scan
et al. (2023) outcomes Adult sheath (17–34.8) stenting for UTI surgery dis-
[25] randomized mm
between urinary leak continuation,
Superperc and no
miniPCNL (5%) transfusion
without suction needed
Multicentre Presentation of Fever Haematuria
Zeng G. et al. 45.6 ± Fever (11.3%), not requiring
prospective Super- Adult and 22 ± 6 (7–51) 10–14 SMP 21.5 12.8 haematuria 11.3 requiring 1.4 85.8 CT scan
(2016) [24] non- miniPCNL paediatric mm (25–115) (1.4%) blood
randomised (SMP) antibiotics transfusion
Introduction of
SMP and
description of grade I
Zhao Z. et al. Retrospective its application 23 ± 9 mm 10– SMP 54.3 ± 5.1 (3.8%), 5.1 Fever 0 94.4 not
(2017) ** [19] in practice in Adult 12–14 27.7 grade II (>38.5 → C) specified
adult and (1.3%)
paediatric
patients
J. Clin. Med. 2024, 13, 2558 8 of 21

Table 1. Cont.

Access Type of Operative Compli- Infectious Infectious Final

Authors Nature of the Aim of the Total Stone Suction IRP Complication Compli- Bleeding Bleeding SFR
Population Sheath (mmHg) Time cation Complica- SFR Method
(Year) Study Study Size * Size Sheath/ (min) Rate (%) Notes cation tion Notes Rate (%) Notes (%)
Device Rate (%)
Introduction of
SMP and
description of grade I 4 cases of
haematuria
Zhao Z. et al. Retrospective its application 14 ± 6 mm 10– SMP 39.4 ± 15.3 (9%), 6.3 Fever 8.1 not requiring 95.5 not
(2017) ** [19] in practice in Paediatric 12–14 26.2 grade II (>38.5 → C) specified
blood
adult and (6.3%) transfusion
paediatric
patients
Evaluation of
safety and grade I Fever
Cai C. et al. Retrospective efficacy of new Adult and 31.57 ± 9.8 12–14 SMP 16 (6.4%), 10.6 (>38.5 → C— 0 91.5 CT scan
(2018) [20] paediatric mm 35 (6–127) grade II 9.6%),
generation SMP
in ↑20 mm (9.6%) sepsis (1%)
renal stones

Zeng g. et al. Presentation of 32.9 ±

Retrospective the new Adult 24 ± 8 mm 14 SMP 20.8 ±9.2 23.0 5.1 Fever 5.1 0 91.5 CT scan
(2017) [23] generation SMP
Determination
of renal pelvic
pressure in SMP 2 cases of
Alsmadi J. Prospective 19.51 ± Fever (5.4%), haematuria
and evaluation 306.5 ± 14 SMP 5.83 39.28 ± 8.1 5.4 Fever 2.7 not requiring 90.5 CT scan
et al. (2018) of incidence of Adult 210.65 mm2 24.4 haematuria
[34] observational mmHg (2.7%)
postoperative blood
transfusion
infectious
complications
To present a
suction-
miniPCNL 2 cases of
system with bleeding
monitoring and Patented IRP kept requiring
Yang Z. et al. 50 mm (range Fever (5%),
Retrospective control of 16–18 suctioning between 120 8.3 bleeding 5 Fever 3.3 transfusions, 83.9 CT scan
intrarenal Adult (80–200)
(2016) [11] 40–65) MPCNL –12 to 2 1 of which
pressure and to sheath mm Hg (3.3%) requiring
evaluate its angioemboli-
clinical efficacy sation
and
characteristics
Comparison of
standard
miniPCNL vs.
miniPCNL Fever (11%)
using patented Patented or renal
Huang J. et al. Prospective 16.7 ± 5.8 suctioning 54.5 ± pelvic
suctioning Adult 16 12 11 Fever 0 96.7 CT scan
(2016) [35] randomized mm MPCNL 14.5
sheath in sheath perforation
patients with (1%)
stones
complicated by
pyonephrosis
J. Clin. Med. 2024, 13, 2558 9 of 21

Table 1. Cont.

Access Type of Operative Compli- Infectious Infectious Final

Authors Nature of the Aim of the Total Stone Suction IRP Complication Compli- Bleeding Bleeding SFR
Population Sheath (mmHg) Time cation Complica- SFR Method
(Year) Study Study Size * Size Sheath/ (min) Rate (%) Notes cation tion Notes Rate (%) Notes (%)
Device Rate (%)
Comparison of
suction Patented All cases of
Prospective miniPCNL vs. KUB
Du C. et al. 1360 ± 520 suctioning 1.8 ± 0.9 Fever, bleeding
multicentre standard PCNL Adult 16–18 56 ± 32 11.6 8 Fever 3.5 81 X-ray and
(2018) [27] mm2 MPCNL mmHg transfusion requiring
CT
randomized vs. traditional
miniPCNL for sheath transfusions
staghorn calculi
KUB
Comparison of X-ray; CT
suctioning Patented in case of
Song L. et al. Prospective miniPCNL 857 ± 225 suctioning Fever (1%, Not uric acid
Adult 16 4.1 ± 1.8 39 ± 10 10 10 Fever 90
(2011) [32] randomized sheath and a mm2 MPCNL 3 cases) reported stones
standard 24 Fr sheath 3–5 days
PCNL after
surgery
Comparison of 10 cases of 3 cases (6.7%)
FURS with Patented fever, 3 of of blood
Chen H. et al. suction vs. suctioning 56.23 ± blood Fever (3 transfusion, KUB
Retrospective Adult 20–30 mm 16 28.35 28.8 transfusion, 6.7 8.9 1 case (2.2%) 95.5 X-ray
(2019) [21] suction MPCNL cases)
miniPCNL for sheath 1 of angioem- of angioem-
2–3 cm stones bolisation bolisation
Abbreviations: CT—computed tomography; Fr—French; FURS—flexible ureteroscopy; IRP—intrarenal pressure; KUB X-ray—kidney, ureter, bladder X-ray; MIP—minimally invasive
percutaneous nephrolithotomy; MPCNL—mini-percutaneous nephrolithotomy; SFR—stone-free rate; SMP—super-mini-percutaneous nephrolithotomy; TFL—thulium fibre laser;
US—ultrasonography; UTI—urinary tract infection; vmPCNL—vacuum-assisted mini-percutaneous nephrolithotomy. * Stone size is expressed as diameter in mm, surface area in mm2 ,
and volume in mm3 , as reported in the relative articles. ** Study reported in 2 different lines, after splitting adult and paediatric series, presented separately in the article.
J. Clin. Med. 2024, 13, 2558 10 of 21

To overcome the possible drawbacks deriving from the occurrence of inflow and
outflow through the same cavity and to further improve the effectiveness of the procedure,
in three articles [15–17], the Clear Petra access sheath is not employed in the conventional
way as previously described. The authors create a double-sheath vacuum-suction system,
wherein a 16 Fr large, 21 cm long inner Clear Petra sheath is inserted into a 20 Fr large,
13 cm long outer one. The oblique arm of the outer sheath is connected to the irrigation
inflow, while the oblique arm of the inner sheath is connected to the aspiration. The
room between the two sheaths serves as the perfusion channel, while the lumen of the
inner sheath represents the outflow channel. An 8/9.8 Fr ureteroscope is used as a mini-
nephroscope and, in contrast with the usual practice, it is not connected to the irrigation
fluid. Small fragments and powder are suctioned between the mini-nephroscope and
the inner sheath throughout the procedure, while larger stones are aspirated when the
nephroscope is withdrawn beyond the oblique arm of the inner sheath. Lithotripsy is
obtained with an Ho:YAG laser and irrigation is provided by a peristaltic pump.
The reported stone-free rate (SFR) for vacuum-assisted Clear Petra miniPCNL proce-
dures ranged from 71.3% to 97.3%, while the complication rates varied from 13.2% to 38.9%.
Infectious complication rate ranged from 5.5% to 27.8%, most of them being cases of fever
managed with antibiotic therapy; very few cases of sepsis were reported. Postoperative
bleeding complication rates ranged from 0 to 7.6%. When specified, most of the cases were
managed by blood transfusions; two cases of angioembolisation were reported in a single
study [22]. Operative time varied in the different studies from a mean of 32.4 ± 9.6 min to
a median of 128 min (IQR 99–167).
Five studies compared miniPCNL procedures performed with the Clear Petra sheath
with non-suctioning miniPCNL procedures [13,14,26,29,31]. Regarding SFR, no studies
found statistically significant differences between the two techniques, except Lievore et al.’s
article [14] reporting an SFR of 89.4% for Clear Petra vs. 78.8% in the non-suctioning
minimally invasive PCNL (MIP) group (p = 0.04); however, tendencies towards higher
success rates for suction techniques were noticeable in other studies [26,31]. Regarding com-
plications, Lievore et al. [14] described a lower infectious complications rate for ClearPetra
procedures than for MIP procedures (7.7% vs. 25% respectively, p < 0.01), and Lai et al. [29]
and Xu et al. [31] reported a lower overall complication rate after Clear Petra miniPCNL
was compared with non-suctioning miniPCNL. All comparative studies [13,14,26,29,31]
reported a significantly lower operative time in the Clear Petra group. This was also
confirmed in the comparative study by Tuoheti et al. regarding the double-sheath Clear
Petra technique [16]. Lievore et al. [14] reported lower fluoroscopy time in the Clear Petra
group [14]. The same study [14] and a study by Xu et al. [31] demonstrated a decreased
need for ancillary devices for fragment recovery in the Clear Petra group.

3.3.2. SuperminiPCNL (SMP)

Five studies report the employ of the SuperminiPCNL (SMP system) [19,20,23,24,34].
The SMP set was developed in 2016 by Guohua Zeng [24]. It consisted of a 7 Fr metallic
dismountable inner sheath with enhanced irrigation capability, hosting a 3 Fr fibre optic
bundle, and a modified clear plastic nephrostomic access sheath (whose calibre ranged
from 10 to 14 Fr), with a lateral oblique branch connected to continuous negative pressure
aspiration. This system was designed to improve visibility and stone fragment retrieval
and to prevent excessive IRPs. In the initial report, this technique was proposed for renal
stones < 2.5 cm and in particular for lower pole stones and stones not amenable to RIRS. In
2017, in order to further enhance endoscopic visualisation and improve fragment extraction,
the same group presented the new generation SMP [23], characterized by a 12 or 14 Ch
irrigation–suction sheath. The irrigation–suction sheath is a two-layered metal structure
that allows irrigation and suction at the same time (the inflow through the space between
the two layers of the sheath, the outflow through the central lumen of the sheath). The
key feature of this sheath is that it allows inflow and outflow from different channels. In
the first-generation SMP or traditional miniPCNL systems, the inflow, coming from the
J. Clin. Med. 2024, 13, 2558 11 of 21

scope, can partially offset the effect of outflow and push the stone fragments back into
the collecting system. The concept of the new generation SMP is the same, subsequently
applied by Zhong-Hua Wu at al. [17] with the Clear Petra double-sheath vacuum-suction
system, as above mentioned. This new-generation technique was described as safe, feasible,
and effective for managing renal calculi < 3 cm [23]. One of the five studies reporting the
SMP series, published by Zhao et al. [19], describes both an adult and a paediatric group of
patients. These two groups are separately reported in Table 1.
Stone free rates in SMP studies ranged from 85.8% to 95.5%, while complication
rates varied from 5.1% to 16%. However, all reported complications were low grade
ones, consisting in fever and light haematuria without need of transfusions. In particular,
haematuria rates ranged from 0 to 8.1% and postoperative fever ranged from 5.4% to 11.3%.
Only two cases of sepsis (1%) were reported in a single study [20]. The mean reported
operative time varied from 32.9 ± 23.0 min to 54.3 ± 27.7 min in the different studies.
For SMP, no comparative studies with non-suction miniPCNL are available.

3.3.3. Superperc (Shah Sheath)

Three articles reported outcomes of the Superperc technique [25,28,30]. This technique
was first described in 2017 by K. Shah and colleagues [28] and it is performed by means
of the so-called Shah sheath, from the name of its inventor. The instrument is composed
of three metallic components: the cannula, the suction master, and the obturator. The
cannula has an inner/outer diameter of 10–12 Fr and a length ranging from 8 to 20 cm. The
suction master, connected to the cannula, is equipped with a large lateral outlet to which
the suction tube is linked. The external part of the suction master is plugged with a silicon
valve mechanism to ensure water and air tightness. This mechanism enables the scope
(a paediatric 4.5/6 Fr ureteroscope) to enter without altering the negative pressure within
the suction master. In the first report, lithotripsy was performed by Holmium laser [28].
They obtained a stone free rate of 96.1% and a complication rate of 5.7%. All reported
complications were cases of fever, and no bleeding complications were observed. The mean
operative time was 40.98 ± 12.09 min.
A subsequent study by Patil A. et al. [30] compared a series of Superperc suction
procedures performed with thulium fibre laser (TFL) with miniPCNL procedures per-
formed with EMS TrilogyTM (combining ballistic and ultrasonic lithotripsy). They found
that SFRs and complication rates were comparable for the two systems. Notably, in the
Superperc group, a 100% stone free rate and a complication rate of 6.7% were obtained;
all complications were urinary tract infections, with no cases of bleeding. Operation time
in the Superperc group was 28.63 ± 18.56 min and it was not significantly different with
respect to the control group.
One more recent study by Pathak N. et al. [25] compared suction miniPCNL per-
formed with the Shah sheath and miniPCNL without suction for 10–30 mm kidney stones.
Lithotripsy was performed with TFL in both groups. In the Superperc group, a significantly
higher SFR than in the control group was described (97.5% vs. 87.5%, p = 0.04). Postopera-
tive complication rates were 10% in the suction group vs. 25% in non-suction procedures.
In the Superperc group, complications were represented by infections (fever or UTI) in 5%
of the cases and by urinary leakage in another 5%, and no cases of postoperative bleeding
were reported. In this group, one procedure was discontinued due to intraoperative bleed-
ing. In the control group, the infectious complication rate was 15%. The operative time was
significantly lower in the suction group (26.5 min vs. 34.8 min; p = 0.021).
Overall, the reported SFR for Superperc procedures ranged from 96.1% to 100%; the
complication rate varied from 5.7% to 10% and the infectious complication rate from 5%
to 5.7%. No relevant bleeding complications were reported in any study. Operative time
varied, in the different studies, from a median of 26.5 min (IQR 17–34.8) to a mean of
40.98 ± 12.09 min.
J. Clin. Med. 2024, 13, 2558 12 of 21

3.3.4. The Suction MiniPCNL Patented Sheath

Five studies reported on the use of a 16 Fr patented nephrostomic sheath with a
perpendicular lateral arm connected to a vacuum aspiration machine for stone gravel
retrieval during lithotripsy [11,21,27,32,35]. The first description of this technique dates
back to 2011 in a paper by Song et al. [32] that compared this new suctioning technique with
standard PCNL. An evolution of this system was reported by the same group in 2015 [11].
In the study they integrated in the system an intelligent control of intrarenal pressure (IRP)
linked to an automatic adjustment of the suctioning to keep IRP in a pre-set safety range.
Three further studies subsequently described the employ of the patented suctioning
sheath in cases of stones complicated by pyonephrosis, in cases of 2–3 cm stone, and
in cases of staghorn stones, comparing this technique with non-suctioning miniPCNL,
with suctioning flexible ureteroscopy, and with standard and non-suctioning miniPCNL,
respectively [21,27,35]. In all the cited reports, the energy source used for lithotripsy in
combination with the suction sheath was Holmium laser.
Overall, the reported stone free rates for suctioning miniPCNL with the patented
sheath ranged from 81% to 96.7%, and complication rates varied from 8.3% to 28.8%. The
most frequent complications were infections, with rates from 5% to 22.2%, while bleeding
complications were less common, ranging from 0 to 6.6%.
Studies comparing the results of suction miniPCNL procedures by means of the
patented sheath with non-suction PCNL techniques [27,32,35] uniformly showed lower
bleeding volume and higher SFR for the former ones. In particular, Song et al. [32] observed
an SFR of 90% for suction miniPCNL and 73.3% for standard 24 Fr PCNL; Huang et al. [35]
reported an SFR of 96.7% in the suction patented sheath group vs. 73.6% in the classic
miniPCNL group; and Du and colleagues [27] had SFRs of 81%, 73%, and 74% in the
suctioning miniPCNL, standard PCNL, and traditional non-suctioning miniPCNL groups,
respectively.
Concerning infectious complications, Du et al. [27] and Huang et al. [35] found a
higher incidence of postoperative fever in the traditional miniPCNL group compared with
the suctioning miniPCNL group (14.8% vs. 8% and 27.4% vs. 11%, respectively).
Huang et al. [35] reported a lower operative time for suction miniPCNL with respect to
standard miniPCNL, while Du and colleagues [27] found lower operative times in suction
miniPCNL than in standard miniPCNL, but they did not observe significant differences in
operative time between suction miniPCNL and standard PCNL. Song et al. [32] did not
report differences in operative time between suctioning miniPCNL and standard PCNL.
Chen and colleagues [21] registered a significantly lower overall complication rate
in flexible ureteroscopy with respect to suction miniPCNL (11.3% vs. 28.8% respectively,
p = 0.039). In this study, no differences in SFR and operative time were recorded between
the techniques.

3.4. Outcome Analysis

The main outcomes of percutaneous surgery for kidney stones are represented by
effectiveness in terms of stone free rate and safety, in particular with regards to infectious
and bleeding complications and operation time. Due to the diverse design of the studies
included in this review to the variable size of the treated stones and to the non-uniform way
of reporting stone size (i.e., diameter, surface area, volume), it is not possible to adequately
compare the different suction-assisted techniques and identify one being better than the
others. However, this is not the primary objective of this review, which rather aims to
identify the general advantages of performing PCNL with the assistance of suction sheaths.
In the following paragraphs, the single outcomes will be analysed in detail.

3.4.1. Stone Free Rate (SFR)

Upon scrutinizing the literature, it is apparent that there is a lack of a standardised
system for evaluating the outcomes of endourological procedures for stones, despite SFR
being one of the primary objectives. The choice of methodology to assess SFR varies
J. Clin. Med. 2024, 13, 2558 13 of 21

widely, with authors employing kidney, ureter, and bladder X-ray (KUB) ultrasounds (US)
and computerized tomography scans (CT scans), either individually or in combination.
Furthermore, one study failed to specify how SFR was determined [19]. Additionally, the
follow-up time for SFR evaluation is often unspecified, or when mentioned, it is left to the
discretion of the authors. Considering these factors, it is evident that the results could be
influenced by the divergent methodologies chosen for SFR evaluation. This is noteworthy,
because these diagnostic tests have varying sensitivities and specificities, and the time lapse
between the procedure and the follow-up may lead to the expulsion of fragments or the
formation of new calculi.
Despite these challenges, our review revealed a broad range of SFRs, spanning from
71.3% to 100%. Specifically, within the Clear Petra group, SFR ranged from 71.3% to 97.3%;
in the SMP group, it ranged from 85.8% to 95.5%; in the Superperc group, it was between
96.1% and 100%; and in the patented suction miniPCNL sheath group, it varied between
81% and 96.7%.
The diversity of outcomes among different studies can be attributed to the hetero-
geneity of characteristics of the treated stones. Some articles focused on staghorn calculi,
others on infected stones, and some on simple cases of urolithiasis, merely demonstrating
the feasibility of the technique. This clinical diversity impedes a direct comparison among
various technologies but underscores the versatility of these systems in effectively treating
a wide range of clinical conditions.
Among the studies included in this review that compared suction miniPCNL tech-
niques with non-suctioning ones, Lievore et al. [14] reported better SFR for Clear Petra
miniPCNL compared with MIP procedures (89.4% vs. 78.8%, p = 0.04); Pathak et al. [25]
showed higher SFR for Superperc than for miniPCNL without suction (97.5% vs. 87.5%);
and Song et al. [32], Huang et al. [35], and Du et al. [27] reported better SFR with the
suctioning patented sheath compared with standard 24 Fr PCNL (90% vs. 73.3%), clas-
sic miniPCNL (96.7% vs. 73.6%), and standard PCNL and traditional non-suctioning
miniPCNL (81% vs. 73% vs. 74%), respectively.
No study showed significantly better SFR with non-suctioning techniques.

3.4.2. Complications
The most frequently observed complications after PCNL included postoperative fever,
infections, and bleeding requiring blood transfusions [2,36,37].
Our review indicates that the overall complication rates for aspiration-assisted PCNL
procedures varied from 1.5% to 38.9%. Specifically, within different groups, the overall
complication rates in the Clear Petra group ranged from 13.2% to 38.9%; in the double-
sheath Clear Petra group, it varied between 1.5% and 2.9%; in the SMP group, it ranged
from 5.1% to 16.0%; in the Superperc group, it went from 5.7% to 10%, and in the patented
suction miniPCNL sheath group, it varied between 8.3% and 28.8%.
There is no uniformity on how adverse events are reported in the different studies. Many
studies used the PCNL adjusted Clavien–Dindo classification [13,14,18–20,22,26,31,33,38],
while other papers just reported detailed complications without categorisation.
Regarding the Clear Petra group, it is noteworthy to mention that the study report-
ing the highest complications rate exclusively involved a complex and fragile paediatric
population, in which PCNL may be considered at higher risk [18]. Analysing the above pre-
sented data, there is a tendency towards a reduction of overall and infectious and bleeding
complications in aspiration-assisted PCNL series compared with non-aspiration groups
but, due to the different designs and characteristics of the studies and the non-uniformity
in reporting adverse events, it is not possible to draw firm conclusions and give a clear
indication whether one technology is significantly superior to others in preventing the most
common complications associated with mPCNL.
J. Clin. Med. 2024, 13, 2558 14 of 21

Infectious Complications
Infections represent a significant risk associated with endourological procedures.
This is primarily due to the frequent colonisation of stones by bacteria, which thrive in
the conducive environment provided by the stone matrix [39]. Additionally, prolonged
endoscopic renal surgery may provoke elevated intrarenal pressures (IRP), which can
facilitate the migration of bacteria from stones and urine into the bloodstream. One of the
objectives of the suction sheaths is to maintain a low IRP during surgery to mitigate such
complications.
In our review, we found that the overall rate of infectious complications varied from 0%
to 27.8%. As previously mentioned, the study reporting most infectious complications was
conducted exclusively on paediatric patients. Excluding this study, the overall infectious
complication rates in the Clear Petra group ranged from 6.6% to 15.6%, and in the double
Clear Petra sheath group from 0 to 2.9%; in the SMP group, they ranged from 5.1% to
11.3%; in the Superperc group, from 5% and 5.7%; and in the patented sheath group, they
were between 5% and 10.9%. In the latter group, the study by Huang et al. [35] reported
the highest rate of infectious complications (11%), specifically analysing a series of stone
complicated by pyonephrosis.
The most frequently reported infectious complication is the development of postop-
erative fever due to urinary tract infection. Only two studies reported cases of sepsis, in
3.5% of cases in Szczesniewski et al.’s study [13] on Clear Petra miniPCNL, and in 1% in
Cai et al.’s study [20] regarding SMP.
In the comparison between suction- and non-suction-assisted mPCNL, Lai et al. [29]
and Xu et al. [31] reported a lower fever rate after Clear Petra miniPCNL than after non-
suctioning miniPCNL (8% vs. 20% and 6.6% vs. 20%, respectively); Lievore et al. [14]
observed a lower rate of infectious complications for Clear Petra miniPCNL procedures
compared with MIP (7.7% vs. 25%, p < 0.01); Pathak N. et al. [25] found less infectious
complications in Superperc than in miniPCNL without suction (5% vs. 15%, respectively);
and Du et al. [27] and Huang et al. [35] reported a lower incidence of postoperative fever
in the suctioning miniPCNL group compared with the non-suctioning miniPCNL one
(8% vs. 14.8%, and 11% vs. 27.4%, respectively).

Bleeding Complications
One of the primary reasons driving urologists to miniaturise PCNL instruments is to
reduce the risk of bleeding.
Among the studies included in this review, we found that the overall rate of bleeding
complications ranged from 0% to 8.9%. Specifically, within the Clear Petra group, the
reported incidence of bleeding complications varied between 2.4% and 7.6%, while no
cases of bleeding were reported in the double Clear Petra sheath studies. In the SMP
group, the bleeding rate varied from 0 to 8.1% without need of transfusions in any case.
In the Superperc group, no cases of postoperative bleeding were observed, but in one
study an intraoperative bleeding required surgery discontinuation [25]. In the patented
sheath group, bleeding complications ranged from 0% to 8.9%. Specific complications,
transfusion rates in the different studies, and ancillary procedures are reported in Table 1.
Analysis of the data reveals that bleeding issues can often be managed conservatively.
When observation alone is insufficient due to a decrease in haemoglobin levels, a blood
transfusion may be the only necessary intervention to address these complications. In cases
in which transfusion alone is inadequate due to the development of pseudoaneurysms of
arterio-venous fistulae, angioembolisation plays a crucial role in achieving a final resolution
of bleeding. The way of reporting bleeding complications is not consistent among different
studies, some of them utilise the PCNL-adapted Clavien–Dindo categorisation [38], others
report the postoperative haemoglobin drop or the measured amount of bleeding, and
others do not specify at all. However, most of the studies report the transfusion rates and
need for angioembolisations.
J. Clin. Med. 2024, 13, 2558 15 of 21

Among the studies comparing suction- and non-suction-assisted PCNL procedures,

a clear tendency towards a reduction in bleeding complications, transfusions, and an-
gioembolisations with aspiration techniques is observed, independently of the suction
sheath used. However, due to the small numbers of bleeding complications in all stud-
ies, most of them did not report a statistical comparison between different groups. Only
Huang et al. [35] reported a reduction in transfusion rate from 16.5% to 0 (p < 0.001) using
the patented suction miniPCNL sheath compared with the traditional miniPCNL sheath
without aspiration.
No study showed lower rates of bleeding complications with non-suctioning techniques.

3.4.3. Operative Time

It is known from the literature that, for safety reasons, the overall operative time form
PCNL should not exceed 2 h [40]. The continuous aspiration through the access sheath in
PCNL, by real time suctioning stone powder and fragments, may significantly reduce the
time and the manoeuvres associated with stone lapaxy after fragmentation and thus limit
the overall operative time.
The way of reporting the operative time is not consistent among different studies,
some of them reporting the overall time from the ureteral catheter placement to the end of
the procedure, others only referring to the percutaneous procedure or to the stone treatment
time. Subsequently, the range of operative times among different studies is particularly
wide, varying from a median of 26 min (IQR 17–34.8 min) to a median of 107 min (IQR
70–125 min).
However, of particular interest is the comparison of operative times between aspiration-
and non-aspiration-assisted PCNL techniques. In this setting, all studies but two [30,32]
described a statistically significant reduction of operative time with a mean shortening of
the procedural time of 19 min. The two studies not reporting a reduction of the operative
time compared the suction-assisted miniPCNL procedures with standard PCNL proce-
dures using the EMS lithotripsy probe [32] and with miniPCNL procedures performed with
the EMS TrilogyTM probe [30] with possible employ of aspiration through the lithotripsy
devices. The overall evidence suggests that the reduction of the operative time appears to
be a clear advantage of the aspirating sheaths.

3.5. Intrarenal Pressure (IRP)

3.5.1. Background
In kidneys without obstruction, IRP at low urine flow rates varies from zero to a few
cmH2O [41]. During diuresis, IRP may surpass 27.2 cmH2 O. In cases of chronic kidney
obstruction, it ranges between 68 and 95.2 cmH2 O, resulting in a subsequent decline as the
kidney undergoes atrophy [9]. For hydronephrosis, a mean basal IRP of 12.1 cmH2 O has
been documented. Notably, alterations in intravesical pressure correspond to changes in
IRP [42]. Consequently, it is imperative to maintain continuous drainage of the urinary
bladder during endourological procedures to avert additional IRP increments.
Pyelorenal backflow may occur as the contents of the renal pelvis and calyceal system
permeate the peripelvic sinus tissue (pyelosinous backflow), renal vein (pyelovenous
backflow), collecting ducts, tubules, or renal interstitium (intrarenal backflow). Hinman
and Redewill [9] demonstrated that pyelovenous backflow in dogs can occur at IRP from
40.8 cmH2 O (30 mmHg) to 47.6 cmH2 O. A significant complication of pyelovenous backflow
is the excessive absorption of irrigation fluid, which can be either extra- or intravascular,
leading to fluid overload, electrolyte imbalance, and cardiovascular instability [43]. Fluid
absorption during PCNL ranges from 50 to 2200 mL [40,44,45]. Fluid may be absorbed
either directly into the opened veins or from a perinephric accumulation of irrigating
fluid [46].
In PCNL, the volume of absorbed fluid rises with increased IRPs and operation
times [42]. The peak fluid absorption occurs after a total irrigation time of 30 min, with
absorbed volumes of 153.8 mL and 1361.9 mL recorded after 30 and 90 min, respectively [45].
J. Clin. Med. 2024, 13, 2558 16 of 21

Consequently, the existing evidence suggests that the overall procedure time should be
limited to 2 h [40].

3.5.2. Infectious Complications and IRPs

After endourological procedures, infectious complications, including sepsis, may
be due to elevated IRPs and subsequent backflow of irrigation fluid and bacteria, often
colonising the stones and the irrigation fluid during lithotripsy [47]. Independent of other
factors, irrigation volume appears to be a significant risk factor for infections [48]. Fever
complicates PCNL, with an overall incidence of 10.8% [2]. Although septic shock after
PCNL has a low reported incidence (0.3–1%), it carries a high mortality rate (66–80%) [49].
Increased IRP is a significant risk factor for postoperative fever and sepsis [10]. Zhong and
colleagues identified a mean renal pelvic pressure higher than 20 mmHg (27.19 cm H2 O)
and an accumulative time with IRP higher than 30 mmHg (40.78 cmH2 O) longer than 50 s
as potential contributing factors to postoperative fever [50]. High irrigation pressure
(272 cmH2 O) in PCNL has been associated with a higher risk of systemic inflammatory
response syndrome (SIRS) (46%) compared with low irrigation pressure (108.8 cm H2 O,
11%) [51].

3.5.3. IRPs and Aspiration-Assisted PCNL Procedures: Review of the Literature

Among the studies included in this review, only a few addressed the topic of IRPs
and reported the related intraoperative measurements. In particular, IRP values were
reported by three studies regarding Clear Petra procedures [22,29,31], two studies regarding
SMP [23,34], and two papers regarding the patented miniPCNL suctioning sheath [27,32].
During miniPCNL with suction with the patented sheath, the mean IRP was
1.8 ± 0.9 mmHg in the study published by Du et al. [27] and 4.1 ± 1.8 mmHg in the
paper by Song and colleagues [32]. In the first one, the mean pressure was significantly
lower than the means of the control groups (traditional miniPCNL without suction with
laser lithotripsy and standard PCNL with ultrasonic lithotripsy); in the second one, the
difference with the control group (standard PCNL with ballistic or ultrasonic lithotripsy)
was not significant. However, in both studies, the mean IRP was lower than the threshold
of 20 mmHg [52].
Regarding Clear Petra aspiration-assisted miniPCNL, Xu et al. [31] measured a mean
IRP of 8.6 ± 2 mmHg with a mean peak of 28.6 mmHg and a mean accumulative time with
IRP > 30 mmHg of 5.2 ± 31.1 s. All the mentioned parameters were significantly lower with
respect to the control group (conventional miniPCNL with pneumatic and laser lithotripsy).
Lai et al. [29] reported a mean IRP of 10.3 ± 4.3 mmHg in the Clear Petra group, lower
than the IRP of 17.8 ± 5.1 mmHg measured in the comparative non-suctioning miniPCNL
group (p < 0.001). In the study by Zanetti et al. on Clear Petra miniPCNL [22], the overall
mean IRP was 13.19 ± 5.99 cmH2 O (9.7 ± 4.4 mmHg) and in no procedure did the mean
IRP overpass the threshold of 27.19 cmH2 O (20 mmHg). The threshold of 30 mmHg was
exceeded in 86% of the procedures during IRP peaks but only in a minority of cases for
prolonged accumulative times (31.8%, 22.7%, and 13.6% for more than 50 s, 60 s, and
70 s, respectively). In this study the highest IRP peaks were registered during pyelograms,
during nephroscopy with closed aspiration and during the puncture.
IRP studies during SMP were conducted by Alsmadi et al. and by Zeng et al. [23,34].
In Alsmadi’s study [34], an overall mean IRP of 19.51 ± 5.83 mmHg was registered and a
mean IRP higher than 20 mmHg was observed in 29.7% of the procedures. The threshold
of 30 mmHg was exceeded for at least one peak in 79.7% of the cases, and it was surpassed
for accumulative times longer than 50 s, 60 s, and 70 s in 36%, 32.4%, and 27% of the cases,
respectively. Zeng and colleagues’ study [23] reported a mean IRP of 20.8 ± 9.2 mmHg,
with 80.5% of patients having at least one episode of IRP > 30 mmHg. Mean accumulative
time of IRP > 30 mmHg was 87.9 s.
J. Clin. Med. 2024, 13, 2558 17 of 21

The employ of a peristaltic pump for irrigation in SMP studies may explain the slightly
higher IRPs reported in these studies with respect to Zanetti et al.’s [22] report on Clear
Petra, in which irrigation was guaranteed by gravity.
Specific studies associating the onset of infectious complications with mean IRPs and
IRP peaks during aspiration-assisted miniPCNL are lacking.

3.6. Paediatric Population

We included in our review studies conducted entirely or partially in paediatric pa-
tients. Specifically, Gallioli et al. focused solely on Clear Petra miniPCNL procedures in
children [18], while Zhao et al. differentiated results of SMP procedures based on age [19].
Three other studies included children without distinguishing between adult and paediatric
data; two of them regarded SMP procedures [20,24] and one of them focused on Superperc
procedures [28]. The size of the sheaths varied depending on the systems; for the Clear
Petra system, 14–16 Ch sheaths were employed; for SMP, 10–14 Ch sheaths were used. The
only study on paediatric patients using the Shah sheath did not provide selective data from
the paediatric population and thus cannot be considered in this section.
The Clear Petra [18] was a multicentric retrospective study including a total of
18 aspiration-assisted miniPCNL procedures in 13 patients. The mean stone size was
32 mm. The authors reported an SFR of 81.3%, which enhanced to 93.8% after ancillary pro-
cedures. The overall complication rate was 38.9%, with six out of seven total complications
being minor ones (Clavien ↓ 2). The infectious complication rate was 27.8%, all being cases
of fever, with one needing the placement of a double J stent postoperatively. No cases of
bleeding requiring transfusions were reported.
In the SMP study [19], a retrospective series of 111 children treated in a single centre
was reported. The mean stone size was 14 mm. An SFR of 95.5% and a total complication
rate of 15.3% were reported. Infectious complications, in the form of fever, were registered
in 6.3% of the cases, while bleeding complications had an incidence of 8.1%, all being cases
of transient haematuria, none requiring blood transfusion or further procedures.
Children with stones are often affected by anatomical and/or metabolic disorders, as
it was for 9 out of the 16 paediatric patients included in the mentioned study on Clear Petra
procedures by Gallioli et al. [18]. This, combined with the large size of the stones treated in
this study, may explain the higher complication rate reported with respect to other adult
and paediatric papers.
Based on the available data, miniPCNL performed with suction sheaths appears to
be suitable for paediatric patients and ensures satisfactory SFRs and an adequate safety
profile. However, in fragile paediatric patients even more than in adults, percutaneous renal
surgery should be performed cautiously and only in very experienced and high-volume
centres, especially in view of the safety and efficacy of less invasive treatment modalities
such as SWL in this cohort [53].

3.7. Limitations of This Study

This systematic review of the existing literature provides a comprehensive and de-
tailed analysis of the currently existing aspiration devices applied to nephrostomic access
sheaths during percutaneous nephrolithotomy (PCNL). The interest of the urological com-
munity on suction devices has dramatically increased in the setting of both PCNL and
RIRS [54]. However, technical insights and potential limitations of each device should be
fully acknowledged in order to select the most appropriate instrument for each clinical
scenario.
We applied strict selection criteria to analyse the unique features of the currently avail-
able suction-assisted nephrostomic access sheaths, namely the Clear Petra® nephrostomic
access sheath, the Superperc (Shah sheath), the superminiPCNL (SMP), and the Chinese-
patented suctioning sheath. Additionally, we included in our analysis only those studies
reporting outcomes of safety (overall complication rate, infectious and bleeding complica-
J. Clin. Med. 2024, 13, 2558 18 of 21

tion rates, operative time) and effectiveness (SFR) of these devices, either in descriptive or
comparative studies.
However, despite the rigorous selection criteria, a significant heterogeneity of the
included studies is inevitable and does not allow to gather strong evidence-based impli-
cations. First, as already mentioned, total stone size and its measurement were widely
heterogeneous among the selected studies, inevitably impacting the operative times and
clinical postoperative course. Recent evidence has demonstrated that stone volume might
better represent the real stone burden and predict stone-free status [55]. A stricter selec-
tion of patient cohorts based on stone volume is therefore advised to rigorously compare
different endourological techniques.
In addition, non-uniformity was noted in the way complications were reported among
studies, with some utilising the modified Clavien classification, while others specifically
reported single adverse events.
Moreover, significant heterogeneity was found with regards to irrigation modalities,
which may influence intraoperative renal pressures and therefore clinical outcomes. Finally,
timing and modality of assessment of stone-free status after surgery and definitions of
stone-free status were highly variable. A standardised approach to stone surgery follow-up
according to the recently published algorithm from the EAU Urolithiasis Panel should be
implemented in the clinical practice and reporting outcomes of stone surgery [56].

3.8. Patient Safety and Quality of Life Outcomes

As physicians, we should acknowledge the impact of stones and stone-related surgery
on patients’ experiences and postoperative quality of life (QoL). Evidence shows that
patients appreciate being involved in the clinical decision-making process; thus, preop-
erative counselling of patients on the proposed procedure and the acknowledgment of
their expectations and understanding of surgery-related risks is of paramount importance
in our clinical practice [57]. Different validated questionnaires have been used to assess
QoL after PCNL; notably, factors such as stone site, tract size, postoperative drainage
modality, and type of anaesthesia have been correlated with patients’ physical and mental
domains. Interestingly, patients treated with miniPCNL showed better social and vital-
ity scores compared with those treated with RIRS, possibly due to the negative effect of
the ureteric stent. A PCNL exit strategy seems to play a distinctive role in this regard,
since postoperative scores were significantly worse in the stented patients compared with
those with a nephrostomy tube or ureteric catheter, as they experienced more emotional
and social dysfunction [58]. Therefore, the trend of suction-assisted miniPCNL nephros-
tomic devices towards a reduction of overall infectious and bleeding complications might
support physicians and patients in clinical decisions in order to achieve a “personalised
stone approach”.

4. Conclusions
Suction-assisted nephrostomic sheaths in miniPCNL can guarantee satisfactory stone
free rates maintaining a good safety profile both in adult and paediatric patients. When
compared with non-suction assisted PCNL, despite the wide heterogeneity of techniques
and patient cohorts, a clear trend is evident towards a reduction of overall infectious and
bleeding complications in aspiration-assisted procedures, alongside equivalent or better
SFRs. Moreover, the shortening of the operative time with respect to PCNL procedures
performed without aspirating sheaths is a consistent result. SuperminiPCNL and Clear
Petra miniPCNL seem to be safe and feasible also in paediatric patients.
Limited evidence on IRP measurement in suction-assisted PCNL seems to confirm
safety pressure ranges during these procedures.
Only a more established and widespread use of these techniques will provide the
robust and high quality evidence that is currently lacking.
J. Clin. Med. 2024, 13, 2558 19 of 21

Author Contributions: Conceptualisation, M.N. and S.P.Z.; methodology, M.N., S.P.Z. and F.R.;
formal analysis M.N. and S.P.Z.; resources, M.N., F.R. and S.P.Z.; data curation S.P.Z., E.D.L., E.Z.,
F.L. and L.B.; writing—original draft preparation M.N.; writing—review and editing S.P.Z. and M.N.;
visualization E.D.L., E.Z., F.L. and L.B; supervision, S.P.Z., G.A. and E.M.; project administration,
S.P.Z. All authors have read and agreed to the published version of the manuscript.
Funding: This study was (partially) funded by the Italian Ministry of Health—Current Research IRCCS.
Institutional Review Board Statement: Not applicable.
Informed Consent Statement: Not applicable.
Data Availability Statement: All data are available in the studies included in the review and are
discussed in the present manuscript.
Conflicts of Interest: The authors declare no conflicts of interest.

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