IMPORTANCE Nonsteroidal anti-inflammatory drugs (NSAIDs) have many physiologic effects and are be... more IMPORTANCE Nonsteroidal anti-inflammatory drugs (NSAIDs) have many physiologic effects and are being used more commonly to treat postoperative pain, but recent small studies have suggested that NSAIDs may impair anastomotic healing in the gastrointestinal tract. OBJECTIVE To evaluate the relationship between postoperative NSAID administration and anastomotic complications. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study of 13,082 patients undergoing bariatric or colorectal surgery at 47 hospitals in Washington State from January 1, 2006, through December 31, 2010, using data from the Surgical Care and Outcomes Assessment Program linked to the Washington State Comprehensive Abstract Reporting System. EXPOSURE NSAID administration beginning within 24 hours after surgery. MAIN OUTCOMES AND MEASURES We used multivariate logistic regression modeling to assess the risk for anastomotic complications (reoperation, rescue stoma, revision of an anastomosis, and percutaneous drain...
RESULTS Of the 13 082 patients (mean [SD] age, 58.1 [15.8] years; 60.7% women), 3158 (24.1%) rece... more RESULTS Of the 13 082 patients (mean [SD] age, 58.1 [15.8] years; 60.7% women), 3158 (24.1%) received NSAIDs. The overall 90-day rate of anastomotic leaks was 4.3% for all patients (151 patients [4.8%] in the NSAID group and 417 patients [4.2%] in the non-NSAID group; P = .16). After risk adjustment, NSAIDs were associated with a 24% increased risk for anastomotic leak (odds ratio, 1.24 [95% CI, 1.01-1.56]; P = .04). This association was isolated to nonelective colorectal surgery, for which the leak rate was 12.3% in the NSAID group and 8.3% in the non-NSAID group (odds ratio, 1.70 [95% CI, 1.11-2.68]; P = .01).
4043 Background: The optimal surgical (S) approach to BRPC is unknown. We evaluated an approach t... more 4043 Background: The optimal surgical (S) approach to BRPC is unknown. We evaluated an approach to BPRC using extended course chemotherapy (CT) without routine neoadjuvant chemoradiation (CRT). Clinical outcomes were evaluated on an "intent to treat" basis. Methods: Patients (pts) were identified from a prospectively-maintained database started in 2008. Pts required 1) Dx BRPC with non-tail primary per radiographic staging using AHPBA/NCCN guidelines 2) No prior therapy (Rx) 3) Negative staging/exploratory laparoscopy prior to S 4) All cancer Rx at VMMC prior to S. Pts received gemcitabine/docetaxel (G/D) as initial CT. Pts with systemic progression/comorbid complication prior to 24 wks were not offered local Rx; pts with localized cancer at 24 wks judged likely to achieve R0 resection were offered S; all other pts were offered fluoropyrimidine-based CRT. Results: Of 76 identified pts (median age 66), 12 (16%) are on initial CT and not fully evaluable. G/D as sole CT achie...
771 Background: As neoadjuvant Rx for resected PDAC often includes chemoradiation, the PV of PR i... more 771 Background: As neoadjuvant Rx for resected PDAC often includes chemoradiation, the PV of PR includes its impact. We began analysis of the impact of NC alone in this setting. Methods: Patients (pts) were identified from the Virginia Mason Pancreaticobiliary Cancer Database. Inclusion criteria: 1) Dx 1/2010 - 3/2019; 2) Path dx PDAC stage I-III; 3) NC ( any type) as sole neoadjuvant Rx; 4) complete surg path data; 5) longitudinal OS known. Exclusion criteria: 1) neoadjuvant chemoradiation; 2) unknown NC (outside providers only). Histologic response was scored as follows: ( 0=complete response, 1 ≥95% response, 2=50-95% response, 3<50% response). Results: Results for 134 pts are in Table. Median (med) f/u was 33 months (mo). In univariate analysis, all path features examined were statistically significant re med/5-yr OS. In multivariate analysis, risk increased with tumor size (HR 1.9, 95% CI 1.1-3.2) and tumor differentiation (HR 1.8, 95% CI 1.1-3.1 ) independent of other varia...
e15693Background: Adjuvant rx using single-agent gem in resected PC typically has produced median... more e15693Background: Adjuvant rx using single-agent gem in resected PC typically has produced median / 5-year (yr) survivals of 18-22 months (mo)/ 10%, respectively. As taxanes added to gem improved O...
The accurate diagnosis of a liver mass can usually be established with a thorough history, examin... more The accurate diagnosis of a liver mass can usually be established with a thorough history, examination, laboratory inquiry, and imaging. The necessity of a liver biopsy to determine the nature of a liver mass is rarely necessary. Contrast-enhanced computed tomography and magnetic resonance are the standard of care for diagnosing liver lesions and high-quality imaging should be performed before performing a biopsy. This article discusses current consensus guidelines for imaging of liver masses, as well as masses found on surveillance imaging. The ability to accurately characterize lesions requires proper use and understanding of the technology and expert interpretation.
Unlike pancreatic head tumors, little is known about the biological significance of radiographic ... more Unlike pancreatic head tumors, little is known about the biological significance of radiographic vessel involvement with pancreatic body/tail adenocarcinoma. We hypothesized radiographic splenic vessel involvement may be an adverse prognostic factor.
Although race and socioeconomic status have been shown to affect outcomes in pancreatic ductal ad... more Although race and socioeconomic status have been shown to affect outcomes in pancreatic ductal adenocarcinoma (PDAC), the impact of rural residence on the delivery of adjuvant therapy (AT) has not been studied. Patients with resected PDAC were identified using the National Cancer Database (NCDB). Individuals were classified as living in a metro area, urban/rural adjacent to a metro area (URA), and urban/rural remote (URR) area. Multivariate logistic regression was used to assess geographic inhabitance as a predictor of receiving AT. A total of 32 521 individuals who underwent pancreatectomy for PDAC were identified. Univariate analysis demonstrated individuals in URR areas were less likely to receive adjuvant chemotherapy (ACT) than those living in URA or metro areas (55.3% vs 55.6% vs 58.8%, P = 0.011). However on multivariate analysis URR inhabitance was no longer a predictor of ACT (OR = 0.911 P = 0.125) or ART (OR = 0.953 P = 0.462). Cox proportional hazard modeling demonstrated...
365 Background: Pancreatic ductal adenocarcinoma (PDAC) is characterized by dense stroma and conn... more 365 Background: Pancreatic ductal adenocarcinoma (PDAC) is characterized by dense stroma and connective tissue growth factor (CTGF) overexpression. Although prolonged overall survival (OS) can be achieved through resection, only approximately 15% to 20% of patients are treated with surgery. Previously, pamrevlumab (P), a fully human monoclonal antibody blocking CTGF, was combined with gemcitabine/erlotinib (G/E) in a study of advanced PDAC. P plasma levels of > 150 μg/mL and low baseline CTGF levels resulted in prolonged OS. We hypothesize that neoadjuvant (NA) treatment of LAPC with P + G/nab-paclitaxel (NP) may alter LAPC’s stroma, increase R0 resectability, and improve OS similar to that of patients resectable at presentation. Methods: LAPC subjects, confirmed by NCCN criteria and staging laparoscopy, were randomized 2:1 to G/NP ± P for 6-cycle/24-week treatment. Safety and efficacy (resection rate, OS, progression-free survival, tumor response) were assessed. Resection was pe...
236 Background: The optimum approach to maximize R0 resection rate in BRPC is unknown. We evaluat... more 236 Background: The optimum approach to maximize R0 resection rate in BRPC is unknown. We evaluated an approach in BRPC using extended duration neoadjuvant CT, typically without neoadjuvant CRT to assess R0 resection rate on an "intent to treat"basis. Methods: Patients (pts) were identified from a prospectively-maintained database from 2008-2012. Pts required (1) BRPC per radiographic staging using NCCN/AHPBA criteria, (2) no prior PC therapy (rx) PC, (3) negative staging laparoscopy prior to rx, and (4) all cancer rx at VMMC prior to decision on "downstaging" surgery (S). Pts were initially treated with gemcitabine/docetaxel CT until (a) disease progression, or (b) 24 weeks (wks), before assessment for local rx. Pts with systemic progression and/or inability to complete 24 wks of CT were excluded from local rx; pts with localized cancer at 24 wks judged unlikely to achieve R0 resection were offered 5FU-based CRT then reassessed; all other pts were offered S. Res...
321 Background: As neoadjuvant therapy of locally advanced, borderline resectable pancreatic canc... more 321 Background: As neoadjuvant therapy of locally advanced, borderline resectable pancreatic cancer (BRPC) is becoming more widely utilized; better indicators of progression are needed to help guide therapeutic decisions. The aim of this study is to determine if CA19-9 response during treatment predicts disease progression. Methods: A retrospective review was performed on all patients with BRPC (by AHPBA/SSO consensus criteria) between 2008-2015 who received 24 weeks of neoadjuvant gemcitabine and docetaxel. Patients with medical comorbidities limiting treatment completion were excluded. Serum CA19-9 levels were checked at baseline and every 3 weeks while on therapy. A normal CA19-9 level was defined as < 37.5 units/mL and levels with concomitant biliary obstruction were censored. CA19-9 response was analyzed as a predictor of disease progression, recurrence, and survival. Results: Eighty patients were included with a mean of 11 CA19-9 levels checked per patient during treatment....
TPS500 Background: Only 15% of patients with pancreatic ductal adenocarcinoma (PDAC) are eligible... more TPS500 Background: Only 15% of patients with pancreatic ductal adenocarcinoma (PDAC) are eligible for resection. Patients with locally advanced PDAC may become candidates for surgery following donwstaging with neoadjuvant therapy. PDAC often exhibits a high degree of desmoplasia, characterized by extensive connective tissue stroma. FG-3019 is a recombinant human monoclonal antibody that binds to connective tissue growth factor and significantly reduces tumor growth, neovascularization, and metastases in mouse models of PDAC. Therefore, FG-3019 may change the fibrotic character of PDAC to one more amenable to resection. In a phase I trial of stage III/IV patients, FG-3019 did not add toxicity when combined with gemcitabine and erlotinib. Methods: Phase 1/2, randomized, open-label trial to evaluate safety and tolerability of gemcitabine plus Nab-paclitaxel with FG-3019 or gemcitabine plus Nab-paclitaxel in subjects with locally advanced, unresectable PDAC (clinicaltrials.gov #NCT02210...
457 Background: Curative therapy for PDAC is currently achievable through resection only, but ≤ 1... more 457 Background: Curative therapy for PDAC is currently achievable through resection only, but ≤ 15% of patients are candidates for surgery. FG-3019, a recombinant human mAb to connective tissue growth factor (CTGF), plus gemcitabine (G) significantly reduced tumor growth, increased apoptosis and improved survival vs G alone in the KPC mouse model. Higher FG-3019 exposure and lower baseline (BL) CTGF were independently and significantly associated with improved overall median and 1-year survival (OS) in a Ph2a trial with G and erlotinib in stage 3 or 4 PDAC. Neoadjuvant treatment of LAPC with FG-3019 combined with multidrug therapy may change the fibrotic character of LAPC and thus may make it amenable to surgical resection and potentially improve OS. Methods: Patients with unresectable LAPC (confirmed by laparoscopy) are randomized to G/NP ±FG-3019 for 6-cycle/24-week treatment. Safety, efficacy, PK and changes in CT, PET, & CA19.9 from BL through end of treatment (EOT) are assessed...
Abstract This video demonstrates a technique for creation of an omental tissue barrier to protect... more Abstract This video demonstrates a technique for creation of an omental tissue barrier to protect a portomesenteric vein reconstruction or gastroduodenal artery (GDA) stump. Following routine pancreatoduodenectomy reconstruction, a generous tongue of omentum is mobilized off the transverse colon ensuring to preserve the feeding branches from the left gastroepiploic artery. The omentum is then passed behind the pancreatojejunostomy above the vein repair site. It is grasped superiorly and passed anterior to the pancreatojejunostomy to exclude the GDA stump. The flap is then secured to the blind end of the jejunum with suture thereby completing the circumferential wrap. Care must be taken in obese patients to trim the flap so it can fit behind the pancreas without devascularizing it or causing tension on the pancreatojejunostomy. If a closed suction drain is desired, it can be passed from the patient's right either in front of or behind the hepaticojejunostomy and placed around the flap. This technique is most applicable to patients with moderate to high risk of pancreatic fistula (small pancreatic duct and/or soft gland) after undergoing PD with an intact omentum. This circumferential, pedicled omental flap is an easy, reproducible, and durable method to protect vascular structures and repairs from pancreatic fistulas.
177 Background: Distinguishing bile duct carcinoma from other diagnoses is often difficult using ... more 177 Background: Distinguishing bile duct carcinoma from other diagnoses is often difficult using endoscopic or percutaneous techniques. The cell surface protein CEACAM6 is over-expressed in many gastrointestinal cancers and may be selectively elevated in biliary adenocarcinoma. The aim of the present study is to determine if CEACAM6 can be detected in the bile of patients with biliary cancer and can serve as a diagnostic biomarker for cholangiocarcinoma. Methods: Bile duct and gallbladder bile from patients with benign biliary disease and cholangiocarcinoma (hilar, intrahepatic and distal) was collected at the time of index operation. The concentration of CEACAM6 was quantified by sandwich enzyme-linked immunosorbent assay (ELISA) and correlated to pathologic diagnosis. Diagnostic capability of CEACAM6 was evaluated by Wilcoxon rank-sum, logistic regression, and receiver operating characterisitic (ROC) curve analysis. Results: Bile from 73 patients was analyzed: 40 with benign disea...
Pancreatic cancer patients with positive peritoneal cytology (PPC) as a sole metastatic site are ... more Pancreatic cancer patients with positive peritoneal cytology (PPC) as a sole metastatic site are poorly characterized. Whether they behave similarly to other stage IV patients is unknown. Patients with stage IV disease at our institution between 2003 and 2013 were identified. Inclusion criteria for PPC cohort were PPC at laparoscopy and no laparoscopic and/or radiographic evidence of metastasis. Patients with gross metastasis had laparoscopic and/or radiographic evidence of metastasis. Among 308 patients, 43 patients had PPC and 265 had gross metastasis. PPC cohort: 3 (7%) resectable, 8 (19%) borderline resectable, and 32 (74%) unresectable tumor. Disease progression occurred in 37 (86%). Sixteen of 43 (37%) also received local therapy (1 surgery and 15 chemoradiation). PPC vs gross metastasis cohort differed as follows: baseline Ca 19-9 (440 vs 1,904 IU/mL, P < .0001); Eastern Cooperative Oncology Group (ECOG) score ≤1 (98 vs 88%, P = .04); median overall survival (13.9 vs 9.4 m...
IMPORTANCE Nonsteroidal anti-inflammatory drugs (NSAIDs) have many physiologic effects and are be... more IMPORTANCE Nonsteroidal anti-inflammatory drugs (NSAIDs) have many physiologic effects and are being used more commonly to treat postoperative pain, but recent small studies have suggested that NSAIDs may impair anastomotic healing in the gastrointestinal tract. OBJECTIVE To evaluate the relationship between postoperative NSAID administration and anastomotic complications. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study of 13,082 patients undergoing bariatric or colorectal surgery at 47 hospitals in Washington State from January 1, 2006, through December 31, 2010, using data from the Surgical Care and Outcomes Assessment Program linked to the Washington State Comprehensive Abstract Reporting System. EXPOSURE NSAID administration beginning within 24 hours after surgery. MAIN OUTCOMES AND MEASURES We used multivariate logistic regression modeling to assess the risk for anastomotic complications (reoperation, rescue stoma, revision of an anastomosis, and percutaneous drain...
RESULTS Of the 13 082 patients (mean [SD] age, 58.1 [15.8] years; 60.7% women), 3158 (24.1%) rece... more RESULTS Of the 13 082 patients (mean [SD] age, 58.1 [15.8] years; 60.7% women), 3158 (24.1%) received NSAIDs. The overall 90-day rate of anastomotic leaks was 4.3% for all patients (151 patients [4.8%] in the NSAID group and 417 patients [4.2%] in the non-NSAID group; P = .16). After risk adjustment, NSAIDs were associated with a 24% increased risk for anastomotic leak (odds ratio, 1.24 [95% CI, 1.01-1.56]; P = .04). This association was isolated to nonelective colorectal surgery, for which the leak rate was 12.3% in the NSAID group and 8.3% in the non-NSAID group (odds ratio, 1.70 [95% CI, 1.11-2.68]; P = .01).
4043 Background: The optimal surgical (S) approach to BRPC is unknown. We evaluated an approach t... more 4043 Background: The optimal surgical (S) approach to BRPC is unknown. We evaluated an approach to BPRC using extended course chemotherapy (CT) without routine neoadjuvant chemoradiation (CRT). Clinical outcomes were evaluated on an "intent to treat" basis. Methods: Patients (pts) were identified from a prospectively-maintained database started in 2008. Pts required 1) Dx BRPC with non-tail primary per radiographic staging using AHPBA/NCCN guidelines 2) No prior therapy (Rx) 3) Negative staging/exploratory laparoscopy prior to S 4) All cancer Rx at VMMC prior to S. Pts received gemcitabine/docetaxel (G/D) as initial CT. Pts with systemic progression/comorbid complication prior to 24 wks were not offered local Rx; pts with localized cancer at 24 wks judged likely to achieve R0 resection were offered S; all other pts were offered fluoropyrimidine-based CRT. Results: Of 76 identified pts (median age 66), 12 (16%) are on initial CT and not fully evaluable. G/D as sole CT achie...
771 Background: As neoadjuvant Rx for resected PDAC often includes chemoradiation, the PV of PR i... more 771 Background: As neoadjuvant Rx for resected PDAC often includes chemoradiation, the PV of PR includes its impact. We began analysis of the impact of NC alone in this setting. Methods: Patients (pts) were identified from the Virginia Mason Pancreaticobiliary Cancer Database. Inclusion criteria: 1) Dx 1/2010 - 3/2019; 2) Path dx PDAC stage I-III; 3) NC ( any type) as sole neoadjuvant Rx; 4) complete surg path data; 5) longitudinal OS known. Exclusion criteria: 1) neoadjuvant chemoradiation; 2) unknown NC (outside providers only). Histologic response was scored as follows: ( 0=complete response, 1 ≥95% response, 2=50-95% response, 3<50% response). Results: Results for 134 pts are in Table. Median (med) f/u was 33 months (mo). In univariate analysis, all path features examined were statistically significant re med/5-yr OS. In multivariate analysis, risk increased with tumor size (HR 1.9, 95% CI 1.1-3.2) and tumor differentiation (HR 1.8, 95% CI 1.1-3.1 ) independent of other varia...
e15693Background: Adjuvant rx using single-agent gem in resected PC typically has produced median... more e15693Background: Adjuvant rx using single-agent gem in resected PC typically has produced median / 5-year (yr) survivals of 18-22 months (mo)/ 10%, respectively. As taxanes added to gem improved O...
The accurate diagnosis of a liver mass can usually be established with a thorough history, examin... more The accurate diagnosis of a liver mass can usually be established with a thorough history, examination, laboratory inquiry, and imaging. The necessity of a liver biopsy to determine the nature of a liver mass is rarely necessary. Contrast-enhanced computed tomography and magnetic resonance are the standard of care for diagnosing liver lesions and high-quality imaging should be performed before performing a biopsy. This article discusses current consensus guidelines for imaging of liver masses, as well as masses found on surveillance imaging. The ability to accurately characterize lesions requires proper use and understanding of the technology and expert interpretation.
Unlike pancreatic head tumors, little is known about the biological significance of radiographic ... more Unlike pancreatic head tumors, little is known about the biological significance of radiographic vessel involvement with pancreatic body/tail adenocarcinoma. We hypothesized radiographic splenic vessel involvement may be an adverse prognostic factor.
Although race and socioeconomic status have been shown to affect outcomes in pancreatic ductal ad... more Although race and socioeconomic status have been shown to affect outcomes in pancreatic ductal adenocarcinoma (PDAC), the impact of rural residence on the delivery of adjuvant therapy (AT) has not been studied. Patients with resected PDAC were identified using the National Cancer Database (NCDB). Individuals were classified as living in a metro area, urban/rural adjacent to a metro area (URA), and urban/rural remote (URR) area. Multivariate logistic regression was used to assess geographic inhabitance as a predictor of receiving AT. A total of 32 521 individuals who underwent pancreatectomy for PDAC were identified. Univariate analysis demonstrated individuals in URR areas were less likely to receive adjuvant chemotherapy (ACT) than those living in URA or metro areas (55.3% vs 55.6% vs 58.8%, P = 0.011). However on multivariate analysis URR inhabitance was no longer a predictor of ACT (OR = 0.911 P = 0.125) or ART (OR = 0.953 P = 0.462). Cox proportional hazard modeling demonstrated...
365 Background: Pancreatic ductal adenocarcinoma (PDAC) is characterized by dense stroma and conn... more 365 Background: Pancreatic ductal adenocarcinoma (PDAC) is characterized by dense stroma and connective tissue growth factor (CTGF) overexpression. Although prolonged overall survival (OS) can be achieved through resection, only approximately 15% to 20% of patients are treated with surgery. Previously, pamrevlumab (P), a fully human monoclonal antibody blocking CTGF, was combined with gemcitabine/erlotinib (G/E) in a study of advanced PDAC. P plasma levels of > 150 μg/mL and low baseline CTGF levels resulted in prolonged OS. We hypothesize that neoadjuvant (NA) treatment of LAPC with P + G/nab-paclitaxel (NP) may alter LAPC’s stroma, increase R0 resectability, and improve OS similar to that of patients resectable at presentation. Methods: LAPC subjects, confirmed by NCCN criteria and staging laparoscopy, were randomized 2:1 to G/NP ± P for 6-cycle/24-week treatment. Safety and efficacy (resection rate, OS, progression-free survival, tumor response) were assessed. Resection was pe...
236 Background: The optimum approach to maximize R0 resection rate in BRPC is unknown. We evaluat... more 236 Background: The optimum approach to maximize R0 resection rate in BRPC is unknown. We evaluated an approach in BRPC using extended duration neoadjuvant CT, typically without neoadjuvant CRT to assess R0 resection rate on an "intent to treat"basis. Methods: Patients (pts) were identified from a prospectively-maintained database from 2008-2012. Pts required (1) BRPC per radiographic staging using NCCN/AHPBA criteria, (2) no prior PC therapy (rx) PC, (3) negative staging laparoscopy prior to rx, and (4) all cancer rx at VMMC prior to decision on "downstaging" surgery (S). Pts were initially treated with gemcitabine/docetaxel CT until (a) disease progression, or (b) 24 weeks (wks), before assessment for local rx. Pts with systemic progression and/or inability to complete 24 wks of CT were excluded from local rx; pts with localized cancer at 24 wks judged unlikely to achieve R0 resection were offered 5FU-based CRT then reassessed; all other pts were offered S. Res...
321 Background: As neoadjuvant therapy of locally advanced, borderline resectable pancreatic canc... more 321 Background: As neoadjuvant therapy of locally advanced, borderline resectable pancreatic cancer (BRPC) is becoming more widely utilized; better indicators of progression are needed to help guide therapeutic decisions. The aim of this study is to determine if CA19-9 response during treatment predicts disease progression. Methods: A retrospective review was performed on all patients with BRPC (by AHPBA/SSO consensus criteria) between 2008-2015 who received 24 weeks of neoadjuvant gemcitabine and docetaxel. Patients with medical comorbidities limiting treatment completion were excluded. Serum CA19-9 levels were checked at baseline and every 3 weeks while on therapy. A normal CA19-9 level was defined as < 37.5 units/mL and levels with concomitant biliary obstruction were censored. CA19-9 response was analyzed as a predictor of disease progression, recurrence, and survival. Results: Eighty patients were included with a mean of 11 CA19-9 levels checked per patient during treatment....
TPS500 Background: Only 15% of patients with pancreatic ductal adenocarcinoma (PDAC) are eligible... more TPS500 Background: Only 15% of patients with pancreatic ductal adenocarcinoma (PDAC) are eligible for resection. Patients with locally advanced PDAC may become candidates for surgery following donwstaging with neoadjuvant therapy. PDAC often exhibits a high degree of desmoplasia, characterized by extensive connective tissue stroma. FG-3019 is a recombinant human monoclonal antibody that binds to connective tissue growth factor and significantly reduces tumor growth, neovascularization, and metastases in mouse models of PDAC. Therefore, FG-3019 may change the fibrotic character of PDAC to one more amenable to resection. In a phase I trial of stage III/IV patients, FG-3019 did not add toxicity when combined with gemcitabine and erlotinib. Methods: Phase 1/2, randomized, open-label trial to evaluate safety and tolerability of gemcitabine plus Nab-paclitaxel with FG-3019 or gemcitabine plus Nab-paclitaxel in subjects with locally advanced, unresectable PDAC (clinicaltrials.gov #NCT02210...
457 Background: Curative therapy for PDAC is currently achievable through resection only, but ≤ 1... more 457 Background: Curative therapy for PDAC is currently achievable through resection only, but ≤ 15% of patients are candidates for surgery. FG-3019, a recombinant human mAb to connective tissue growth factor (CTGF), plus gemcitabine (G) significantly reduced tumor growth, increased apoptosis and improved survival vs G alone in the KPC mouse model. Higher FG-3019 exposure and lower baseline (BL) CTGF were independently and significantly associated with improved overall median and 1-year survival (OS) in a Ph2a trial with G and erlotinib in stage 3 or 4 PDAC. Neoadjuvant treatment of LAPC with FG-3019 combined with multidrug therapy may change the fibrotic character of LAPC and thus may make it amenable to surgical resection and potentially improve OS. Methods: Patients with unresectable LAPC (confirmed by laparoscopy) are randomized to G/NP ±FG-3019 for 6-cycle/24-week treatment. Safety, efficacy, PK and changes in CT, PET, & CA19.9 from BL through end of treatment (EOT) are assessed...
Abstract This video demonstrates a technique for creation of an omental tissue barrier to protect... more Abstract This video demonstrates a technique for creation of an omental tissue barrier to protect a portomesenteric vein reconstruction or gastroduodenal artery (GDA) stump. Following routine pancreatoduodenectomy reconstruction, a generous tongue of omentum is mobilized off the transverse colon ensuring to preserve the feeding branches from the left gastroepiploic artery. The omentum is then passed behind the pancreatojejunostomy above the vein repair site. It is grasped superiorly and passed anterior to the pancreatojejunostomy to exclude the GDA stump. The flap is then secured to the blind end of the jejunum with suture thereby completing the circumferential wrap. Care must be taken in obese patients to trim the flap so it can fit behind the pancreas without devascularizing it or causing tension on the pancreatojejunostomy. If a closed suction drain is desired, it can be passed from the patient's right either in front of or behind the hepaticojejunostomy and placed around the flap. This technique is most applicable to patients with moderate to high risk of pancreatic fistula (small pancreatic duct and/or soft gland) after undergoing PD with an intact omentum. This circumferential, pedicled omental flap is an easy, reproducible, and durable method to protect vascular structures and repairs from pancreatic fistulas.
177 Background: Distinguishing bile duct carcinoma from other diagnoses is often difficult using ... more 177 Background: Distinguishing bile duct carcinoma from other diagnoses is often difficult using endoscopic or percutaneous techniques. The cell surface protein CEACAM6 is over-expressed in many gastrointestinal cancers and may be selectively elevated in biliary adenocarcinoma. The aim of the present study is to determine if CEACAM6 can be detected in the bile of patients with biliary cancer and can serve as a diagnostic biomarker for cholangiocarcinoma. Methods: Bile duct and gallbladder bile from patients with benign biliary disease and cholangiocarcinoma (hilar, intrahepatic and distal) was collected at the time of index operation. The concentration of CEACAM6 was quantified by sandwich enzyme-linked immunosorbent assay (ELISA) and correlated to pathologic diagnosis. Diagnostic capability of CEACAM6 was evaluated by Wilcoxon rank-sum, logistic regression, and receiver operating characterisitic (ROC) curve analysis. Results: Bile from 73 patients was analyzed: 40 with benign disea...
Pancreatic cancer patients with positive peritoneal cytology (PPC) as a sole metastatic site are ... more Pancreatic cancer patients with positive peritoneal cytology (PPC) as a sole metastatic site are poorly characterized. Whether they behave similarly to other stage IV patients is unknown. Patients with stage IV disease at our institution between 2003 and 2013 were identified. Inclusion criteria for PPC cohort were PPC at laparoscopy and no laparoscopic and/or radiographic evidence of metastasis. Patients with gross metastasis had laparoscopic and/or radiographic evidence of metastasis. Among 308 patients, 43 patients had PPC and 265 had gross metastasis. PPC cohort: 3 (7%) resectable, 8 (19%) borderline resectable, and 32 (74%) unresectable tumor. Disease progression occurred in 37 (86%). Sixteen of 43 (37%) also received local therapy (1 surgery and 15 chemoradiation). PPC vs gross metastasis cohort differed as follows: baseline Ca 19-9 (440 vs 1,904 IU/mL, P < .0001); Eastern Cooperative Oncology Group (ECOG) score ≤1 (98 vs 88%, P = .04); median overall survival (13.9 vs 9.4 m...
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