Postprocedure serum amylase or lipase levels predict postendoscopic retrograde cholangiopancreatography pancreatitis: Meta-analysis of diagnostic test accuracy studies and utility assessment.

OBJECTIVES: We aimed to clarify the clinical utility of measuring serum pancreatic enzymes after endoscopic retrograde cholangiopancreatography (ERCP) for the purpose of predicting post-ERCP pancreatitis (PEP) by a meta-analysis of diagnostic test accuracy studies. METHODS: Studies on the prediction accuracy of PEP by serum amylase or lipase measured at 2, 3, and 4 h after ERCP were collected. A literature search was performed in PubMed and the Cochrane Library database for studies published between January 1980 and March 2023. The quality of individual studies was evaluated using the Quality Assessment of Diagnostic Accuracy Studies-2. Data were analyzed using Meta-DiSc 2.0 software. RESULTS: We searched the databases and identified 20 observational studies (12,313 participants). PEPs were defined according to criteria by Cotton or modified Cotton, revised Atlanta criteria, or the Japanese criteria. Meta-analysis of eight studies (4389 participants) showed a pooled sensitivity of 71.1% (95% confidence interval [CI] 56.1-82.5) and pooled specificity of 91.2% (95% CI 85.9-94.6) for the serum amylase cut-off value at 3 times the upper limit of normal (ULN). Another meta-analysis of five studies (1970 participants) showed a pooled sensitivity of 85.8% (95% CI 61.9-95.7) and pooled specificity of 85.3% (95% CI 81.9-88.1) for the serum lipase cut-off value at 3 times ULN. CONCLUSION: Despite a high risk of bias due to various reference standards, this updated meta-analysis and the utility assessment by a decision tree showed the utility of serum amylase or lipase levels more than 3 times ULN measured 2-4 h after ERCP for predicting PEP.

Gastroduodenal Stenting with a Flexible Stent Demonstrates Favorable Clinical Effectiveness despite Gradual Expansion: A Multicenter Prospective Study.

AIMS: This study aimed to evaluate the effectiveness and safety of stenting with a flexible braided self-expandable metal stent (SEMS) for unresectable malignant gastric outlet obstruction (GOO). METHODS: Palliative stenting was prospectively carried out at seven university hospitals between October 2017 and August 2020. All procedures were performed using a flexible branded SEMS of the same brand. The primary endpoint was clinical success rate at 7 days after stenting. Secondary endpoints were procedural success rate, adverse events, recurrent gastric outlet obstruction (RGOO), and patient survival time. RESULTS: Sixty patients were enrolled. The procedural and clinical success rates were 100% and 90%, respectively. RGOO occurred in 15 cases (25%). Adverse events other than RGOO were found in seven cases (12%). The 50% survival time was 75.5 days (range: 52-97 days). Median expansion rates at 1, 3, and 7 days after stenting were 55%, 65%, and 75%, respectively. CONCLUSIONS: A flexible braided stent woven with relatively thin wires was used for malignant GOO. Despite a gradual expansion with slightly lower expansile force, the stent functioned sufficiently well and showed favorable results. Clinical Trials Registry ID: UMIN000029496.

Morphological study of the gastrointestinal tract around the ligament of Treitz using upper gastrointestinal radiography: Fundamental data for EUS-guided gastrojejunostomy.

BACKGROUND/PURPOSE: We developed EUS-guided double-balloon occluded gastrojejunostomy (EPASS) for gastric drainage tract obstruction. The success of EPASS depends on the proximity of the stomach and the gastrointestinal (GI) tract near the ligament of Treitz. The aim of this study is to clarify the GI anatomy near the ligament of Treitz. METHODS: One thousand and sixteen cases imaged upper GI radiography using barium were retrospectively evaluated. Morphologically, the GI tract running near the ligament of Treitz was divided in three types: Type I: The 4th portion of the duodenum (D4) approaches the stomach; Type II: D4 does not approach the stomach; Type III: D4 forms a loop to the jejunum. The minimum distance between the stomach and the GI tract near the ligament of Treitz was measured. RESULTS: Based on the morphological classification, 74.6% in the study group was classified in Type I, 22.0% in Type II, and 3.3% in Type III, respectively. The median minimum distance in Type II/III group were significantly longer, compared with the Type I (P < .01). CONCLUSIONS: The GI anatomy near the ligament of Treitz was clarified using upper GI radiography. It is divided into three patterns, and one-fourth of cases may have difficulty in EUS-guided gastrojejunostomy.

A prospective multicenter study of endoscopic ultrasound-guided fine needle biopsy using a 22-gauge Franseen needle for pancreatic solid lesions.

BACKGROUND AND AIM: While encouraging data of endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) using a 22-gauge Franseen needle have been reported, large-scale data of per pass and quantitative analyses are still lacking. METHODS: This was a multicenter prospective study of EUS-FNB using the 22-gauge Franseen needle for a pancreatic solid lesion. Cytological and histological analyses per pass were evaluated and semi-quantitative analyses were performed on core tissue and blood contamination. Primary end-point was diagnostic accuracy per session. Prognostic factors were analyzed for diagnostic accuracy, sensitivity, core tissue, and blood contamination. RESULTS: A total of 629 passes were performed in 244 cases at 14 centers between 2018 and 2019. The median tumor size was 29 mm, and the puncture was transduodenal in 43%. The median pass number was 2. Diagnostic accuracy per session, at a first pass, and per pass were 93%, 90%, and 88%. In 198 cases with pancreatic cancer, diagnostic sensitivity per session, at a first pass, and per pass were 94%, 89%, and 89%. The rates of core tissue score of 4 and blood contamination score of 3 were 50% and 47%. The adverse event rate was 1.6%. In the multivariate analysis, tumor size ≤20 mm (odds ratio [OR] of 0.46, P = 0.03), transduodenal puncture (OR of 0.53, P = 0.04), and suction (OR of 0.16, P = 0.01) were associated with lower diagnostic accuracy. CONCLUSIONS: The EUS-FNB using the 22-gauge Franseen needle for pancreatic solid lesions showed high per pass and overall diagnostic accuracy.

Impact of Enteral Nutrition Within 24 Hours Versus Between 24 and 48 Hours in Patients With Severe Acute Pancreatitis: A Multicenter Retrospective Study.

OBJECTIVES: In patients with severe acute pancreatitis (SAP), early enteral nutrition (EN) is recommended by major clinical practice guidelines, but the exact timing for the initiation of EN is unknown. METHODS: We conducted a post hoc analysis of the database for a multicenter (44 institutions) retrospective study of patients with SAP in Japan. The patients were classified into 3 groups according to the timing of EN initiation after the diagnosis of SAP: within 24 hours, between 24 and 48 hours, and more than 48 hours. The primary outcome was in-hospital mortality. RESULTS: Of the 1094 study patients, 176, 120, and 798 patients started EN within 24 hours, between 24 and 48 hours, and more than 48 hours after SAP diagnosis, respectively. On multivariable analysis, hospital mortality was significantly better with EN within 48 hours than with more than 48 hours (adjusted odds ratio, 0.49; 95% confidence interval, 0.29-0.83; P < 0.001) but did not significantly differ between the groups with EN starting within 24 hours and between 24 and 48 hours (P = 0.29). CONCLUSIONS: Enteral nutrition within 24 hours may not confer any additional benefit on clinical outcomes compared with EN between 24 and 48 hours.

A case of juvenile eosinophilic cholangitis: Rapid peripheral blood hypereosinophilia after admission leading to diagnosis.

A 15-year-old boy was referred to our hospital with elevated hepatobiliary enzyme levels and jaundice. Magnetic resonance cholangiopancreatography performed at the previous medical facility revealed a stricture of the intrahepatic and extrahepatic bile duct. Computed tomography showed dilatation and wall thickness of the intrahepatic bile ducts. Primary sclerosing cholangitis or cholangiocarcinoma was suspected. Endoscopic retrograde cholangiopancreatography (ERCP) showed stricture in the intrahepatic and extrahepatic bile duct. On admission, the eosinophil count in the peripheral blood was normal; however, rapid hypereosinophilia in the peripheral blood was observed after admission, leading us to suspect eosinophilic cholangitis (EC). A bile duct biopsy showed inflammatory cells and eosinophil infiltration during a second ERCP. The patient was diagnosed with EC based on histopathology.

Successful and Safe Reinstitution of Chemotherapy for Pancreatic Cancer after COVID-19.

Cancer patients are regarded as highly vulnerable to severe acute respiratory syndrome coronavirus (SARS-CoV)-2. However, little is known regarding how cancer treatments should be restarted for cancer patients after coronavirus disease (COVID)-19. We herein report a pancreatic cancer case in which chemotherapy was able to be reinstituted after COVID-19. The patient was a 67-year-old man diagnosed with pancreatic cancer. On day 7 after first chemotherapy, he was infected with COVID-19. A SARS-CoV-2 test was negative after one month of treatment, and we reinstituted chemotherapy. The patient has received three cycles of chemotherapy without recurrence of COVID-19. It may be feasible to reinstitute chemotherapy for cancer patients after a negative SARS-CoV-2 test.

Prediction of the progression of walled-off necrosis in patients with acute pancreatitis on whole pancreatic perfusion CT.

BACKGROUND/PURPOSE: This study investigated whether measuring pancreatic blood volume (PBV) on whole pancreatic perfusion computed tomography (P-CT) can predict the progression of walled-off necrosis (WON) in patients with acute pancreatitis (AP). METHODS: A single-center, retrospective cohort study was conducted between December 2015 and December 2016. The participants were divided into two groups: 14 patients with WON and 15 patients without WON. PBV was measured within 72 hours after the diagnosis of AP, and the final diagnosis of WON was made by contrast-enhanced CT (CE-CT) or endoscopic ultrasonography (EUS) 4 weeks after the onset of AP. RESULTS: The minimum CT value did not differ significantly between the two groups. On the other hand, the minimum PBV was significantly lower in the WON group than in the without WON group (1.4 (0.9-9.9) vs 19.8 (8.2-21.7) mL/100 mL, respectively; P = .02). The cutoff value of the minimum PBV for WON was 16.5 mL/100 mL (sensitivity 100%, specificity 67%, AUC 0.85; P = .001). CONCLUSIONS: Whole pancreatic P-CT can evaluate pancreatic ischemia visually and quantitatively. The minimum PBV measurement on whole pancreatic P-CT within 72 hours after the diagnosis of AP contributes to the prediction of progression of WON.

Etiology and mortality in severe acute pancreatitis: A multicenter study in Japan.

BACKGROUND/OBJECTIVES: Severe acute pancreatitis (SAP) has a high mortality rate despite ongoing attempts to improve prognosis through a various therapeutic modalities. This study aimed to delineate etiology-based routes that may guide clinical decisions for the treatment of SAP. METHODS: Using data from a recent retrospective multicenter study in Japan, we analyzed the association between clinical outcomes, mainly in-hospital mortality and pancreatic infection, and various etiologies while considering confounding factors. We performed additional multivariate analyses and built decision tree models. RESULTS: The 1097 participating patients were classified into the following groups by etiology: alcohol (n = 436, 39.7%); cholelithiasis (n = 230, 21.0%); idiopathic (n = 227, 20.7%); and others (n = 204, 18.6%). Mortality at hospital discharge was 8.4%, 12.2%, 16.7%, and 16.2% in the alcohol, cholelithiasis, idiopathic, and others groups, respectively. According to multivariable analysis, early enteral nutrition (EN) was significantly associated with reduced in-hospital mortality only in the cholelithiasis group. However, there was a consistent association between age and the need for mechanical ventilation and increased mortality, regardless of etiology. Our decision tree models presented different contributing factors depending on the etiology and patient background. Interaction analysis showed that EN and the use of prophylactic antibiotics may influence these results differently according to etiology. CONCLUSIONS: No study has yet used comprehensive models to investigate etiology-related prognostic factors for SAP; our results can, therefore, be used as a reference for improving clinical decisions.

The Effect of an Invasive Strategy for Treating Pancreatic Necrosis on Mortality: a Retrospective Multicenter Cohort Study.

BACKGROUND: Infected acute necrotic collections (ANC) and walled-off necrosis (WON) of the pancreas are associated with high mortality. The difference in mortality between open necrosectomy and minimally invasive therapies in these patients remains unclear. METHODS: This retrospective multicenter cohort study was conducted among 44 institutions in Japan from 2009 to 2013. Patients who had undergone invasive treatment for suspected infected ANC/WON were enrolled and classified into open necrosectomy and minimally invasive treatment (laparoscopic, percutaneous, and endoscopic) groups. The association of each treatment with mortality was evaluated and compared. RESULTS: Of 1159 patients with severe acute pancreatitis, 122 with suspected infected ANC or WON underwent the following treatments: open necrosectomy (33) and minimally invasive treatment (89), (laparoscopic three, percutaneous 49, endoscopic 37). Although the open necrosectomy group had a significantly higher mortality on univariate analysis (p = 0.047), multivariate analysis showed no significant associations between open necrosectomy or Charlson index and mortality (p = 0.29, p = 0.19, respectively). However, age (for each additional 10 years, p = 0.012, odds ratio [OR] 1.50, 95% confidence interval [CI] 1.09-2.06) and revised Atlanta criteria-severe (p = 0.001, OR 7.84, 95% CI 2.40-25.6) were significantly associated with mortality. CONCLUSIONS: In patients with acute pancreatitis and infected ANC/WON, age and revised Atlanta criteria-severe classification are significantly associated with mortality whereas open necrosectomy is not. The mortality risk for patients undergoing open necrosectomy and minimally invasive treatment does not differ significantly. Although minimally invasive surgery is generally preferred for patients with infected ANC/WON, open necrosectomy may be considered if clinically indicated.

Continuous regional arterial infusion versus intravenous administration of the protease inhibitor nafamostat mesilate for predicted severe acute pancreatitis: a multicenter, randomized, open-label, phase 2 trial.

BACKGROUND: Continuous regional arterial infusion (CRAI) of protease inhibitor nafamostat mesilate (NM) is used in the context of predicted severe acute pancreatitis (SAP) to prevent the development of pancreatic necrosis. Although this therapy is well known in Japan, its efficacy and safety remain unclear. METHODS: This investigator-initiated and -driven, multicenter, open-label, randomized, controlled trial (UMIN000020868) enrolled 39 patients with predicted SAP and low enhancement of the pancreatic parenchyma on computed tomography (CT). Twenty patients were assigned to the CRAI group, while 19 served as controls and were administered NM at the same dose intravenously (IV group). The primary endpoint was the development of pancreatic necrosis as determined by CT on Day 14, judged by blinded central review. RESULTS: There was no difference between the CRAI and IV groups regarding the percentages of participants who developed pancreatic necrosis (more than 1/3 of the pancreas: 25.0%, range 8.7-49.1% vs. 15.8%, range 3.4-39.6%, respectively, P = 0.694; more than 2/3 of the pancreas: 20%, range 5.7-43.7% vs. 5.3%, range 0.1-26.0%, respectively, P = 0.341). The early analgesic effect was evaluated based on 24-h cumulative fentanyl consumption and additional administration by intravenous patient-controlled analgesia. The results showed that the CRAI group used significantly less analgesic. There were two adverse events related to CRAI, namely bleeding and splenic infarction. CONCLUSIONS: CRAI with NM did not inhibit the development of pancreatic necrosis although early analgesic effect of CRAI was superior to that of IV. Less-invasive IV therapy can be considered a viable alternative to CRAI therapy.

Safety of endoscopic sphincterotomy in patients undergoing antithrombotic treatment: a retrospective study.

BACKGROUND: This study investigated the safety of endoscopic sphincterotomy in patients undergoing antithrombotic treatment. METHODS: From January 2014 to December 2016, a single-center retrospective study was conducted. Of the 80 patients with naïve papilla receiving antithrombotic treatment who underwent endoscopic sphincterotomy, 76 patients were retrospectively analyzed. We divided the participants into two groups as follows: 45 patients who discontinued antithrombotic treatment (discontinuation group) and 31 patients who continued antithrombotic treatment (continuation group). We evaluated the safety of endoscopic sphincterotomy in patients with naïve papilla who received antithrombotic treatment. RESULTS: The percentage of patients requiring emergency endoscopic retrograde cholangiopancreatography in the continuation group was significantly higher than that in the discontinuation group (55% vs 11%; p = 0.001). The incidence of adverse events did not differ significantly between the two groups. Neither bleeding nor perforation occurred in either group. The length of hospital stay did not differ significantly between the two groups. CONCLUSIONS: Endoscopic sphincterotomy in patients undergoing antithrombotic treatment may be safe if the guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment are followed.

Endoscopic side-by-side uncovered self-expandable metal stent placement for malignant hilar biliary obstruction.

AIM: To investigate outcomes of endoscopic bilateral side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents for unresectable malignant hilar biliary obstruction. METHODS: We retrospectively analyzed 23 patients who underwent endoscopic biliary uncovered self-expandable metal stent placement for unresectable malignant hilar biliary obstruction between January 2015 and September 2016 at our institution. We performed endoscopic side-by-side placement across the papilla using 10-mm-diameter longer-model uncovered self-expandable metal stents. Outcomes included the technical and functional success rates, recurrent biliary obstruction rate, time to recurrent biliary obstruction, reintervention rate, and incidence of adverse events other than recurrent biliary obstruction. RESULTS: Of the 23 patients, 10 with malignant hilar biliary obstruction underwent endoscopic side-by-side uncovered self-expandable metal stent placement across the papilla (median age, 83 years; 6 men). The locations of malignant hilar biliary obstruction were Bismuth types II (n = 3), III (n = 3), and IV (n = 4). The median common bile duct diameter was 8 mm. The technical and functional success rates were 100% and 80%, respectively. Seven patients (70%) developed recurrent biliary obstruction because of stent occlusions, including early hemobilia in two patients and late tumor ingrowth in five patients. The median time to recurrent biliary obstruction was 66 (95% confidence interval: 29-483) days. Six patients (60%) required reintervention, and 1 (10%) underwent transcatheter arterial embolization for right hepatic arterial pseudoaneurysm. Early adverse events other than recurrent biliary obstruction occurred in four patients and late adverse event in one patient. CONCLUSION: Endoscopic side-by-side placement across the papilla using 10-mm-diameter uncovered self-expandable metal stents was technically feasible for unresectable malignant hilar biliary obstruction; however, it might be better to avoid this method for patients with malignant hilar biliary obstruction because of high recurrent biliary obstruction rate and shorter time to recurrent biliary obstruction.

Severe Acute Pancreatitis with Candida Endophthalmitis.

Severe acute pancreatitis (SAP) is a risk factor for candidemia. We report a case of candida endophthalmitis in a 67-year-old man who was admitted to a hospital due to SAP with poorly controlled diabetes. After treatment for SAP, he was diagnosed with candidemia and candida endophthalmitis. We chose appropriate antifungal agents based on the results of a bacterial culture test. After treatment, the disappearance of Candida albicans (C. albicans) from the blood stream was confirmed in blood cultures. In addition, exudative plaques consistent with a fungal infection disappeared. After a diagnosis of candidemia is made, it is important to administer appropriate antifungal therapy and perform frequent ophthalmologic examinations.

Impact of Antimicrobial Prophylaxis for Severe Acute Pancreatitis on the Development of Invasive Candidiasis: A Large Retrospective Multicenter Cohort Study.

OBJECTIVE: Antimicrobial prophylaxis is not generally recommended for patients with severe acute pancreatitis (SAP) owing to the limited clinical benefits. Nonetheless, it is frequently administered in actual practice given the patients' critical condition and the lack of solid evidence showing adverse effects of antimicrobial prophylaxis. We evaluated herein an association between antimicrobial prophylaxis and invasive pancreatic candidiasis as an adverse effect in patients with SAP. METHODS: This is a retrospective cohort study of all consecutive patients with SAP who were admitted to the study institutions (n = 44) between January 1, 2009, and December 31, 2013. We performed multivariable logistic regression analysis adjusting for the extent of pancreatic necrosis and surgical interventions for invasive pancreatic candidiasis. RESULTS: Of the 1097 patients with SAP, 850 (77.5%) received antimicrobial prophylaxis, and 21 (1.9%) had invasive pancreatic candidiasis. In multivariable logistic regression analysis, antimicrobial prophylaxis was significantly associated with the development of invasive pancreatic candidiasis (adjusted odds ratio, 4.23; 95% confidence interval, 1.14-27.6) (P = 0.029). CONCLUSIONS: The results suggest that antimicrobial prophylaxis may contribute to the development of invasive pancreatic candidiasis, and therefore, the routine use of antimicrobial prophylaxis for SAP may be discouraged.

Large Volume Fluid Resuscitation for Severe Acute Pancreatitis is Associated With Reduced Mortality: A Multicenter Retrospective Study.

BACKGROUND AND AIMS: Although fluid resuscitation is critical in acute pancreatitis, the optimal fluid volume is unknown. The aim of this study is to evaluate the association between the volume of fluid administered and clinical outcomes in patients with severe acute pancreatitis (SAP). METHODS: We conducted a multicenter retrospective study at 44 institutions in Japan. Inclusion criteria were age 18 years or older, and diagnosed with SAP from 2009 to 2013. Patients were stratified into 2 groups: administered fluid volume <6000 and ≥6000 mL in the first 24 hours. We evaluated the association between the 2 groups and clinical outcomes using multivariable logistic regression analysis. The primary outcome was in-hospital mortality. Secondary outcomes included the incidence of pancreatic infection and the need for surgical intervention. RESULTS: We analyzed 1097 patients, and the mean fluid volume administered was 5618±3018 mL (mean±SD), with 708 and 389 patients stratified into the fluid <6000 mL and fluid ≥6000 mL groups, respectively. Overall in-hospital mortality was 12.3%. The fluid ≥6000 mL group had significantly higher mortality than the fluid <6000 mL group (univariable analysis, 15.9% vs. 10.3%; P<0.05). In multivariable logistic regression analysis, administration of ≥6000 mL of fluid within the first 24 hours was significantly associated with reduced mortality (odds ratio, 0.58; P<0.05). No significant association was found between the administered fluid volume and pancreatic infection, or between the volume administered and the need for surgical intervention. CONCLUSIONS: In patients with SAP, administration of a large fluid volume within the first 24 hours is associated with decreased mortality.

Multicenter study of endoscopic preoperative biliary drainage for malignant hilar biliary obstruction: E-POD hilar study.

BACKGROUND AND AIM: Endoscopic nasobiliary drainage (ENBD) is often recommended in preoperative biliary drainage (PBD) for hilar malignant biliary obstruction (MBO), but endoscopic biliary stent (EBS) is also used in the clinical practice. We conducted this large-scale multicenter study to compare ENBD and EBS in this setting. METHODS: A total of 374 cases undergoing PBD including 281 ENBD and 76 EBS for hilar MBO in 29 centers were retrospectively studied. RESULTS: Extrahepatic cholangiocarcinoma (ECC) accounted for 69.8% and Bismuth-Corlette classification was III or more in 58.8% of the study population. Endoscopic PBD was technically successful in 94.6%, and adverse event rate was 21.9%. The rate of post-endoscopic retrograde cholangiopancreatography pancreatitis was 16.0%, and non-endoscopic sphincterotomy was the only risk factor (odds ratio [OR] 2.51). Preoperative re-intervention was performed in 61.5%: planned re-interventions in 48.4% and unplanned re-interventions in 31.0%. Percutaneous transhepatic biliary drainage was placed in 6.4% at the time of surgery. The risk factors for unplanned procedures were ECC (OR 2.64) and total bilirubin ≥ 10 mg/dL (OR 2.18). In surgically resected cases, prognostic factors were ECC (hazard ratio [HR] 0.57), predraiange magnetic resonance cholangiopancreatography (HR 1.62) and unplanned re-interventions (HR 1.81). EBS was not associated with increased adverse events, unplanned re-interventions, or a poor prognosis. CONCLUSIONS: Our retrospective analysis did not demonstrate the advantage of ENBD over EBS as the initial PBD for resectable hilar MBO. Although the technical success rate of endoscopic PBD was high, its re-intervention rate was not negligible, and unplanned re-intervention was associated with a poor prognosis in resected hilar MBO.

Side-by-side partially covered self-expandable metal stent placement for malignant hilar biliary obstruction.

BACKGROUND AND STUDY AIMS: This study investigated the feasibility of side-by-side (SBS) partially covered self-expandable metal stent (PCSEMS) placement for unresectable malignant hilar biliary obstruction (MHBO). PATIENTS AND METHODS: We retrospectively analyzed 33 patients from a single center who underwent endoscopic biliary drainage for unresectable MHBO from July 2013 to June 2015. In all patients with bilateral obstruction during complete bilateral intrahepatic cholangiograms, we performed endoscopic SBS placement of a 6-mm diameter PCSEMS using an 8-French delivery system. All patients underwent endoscopic sphincterotomy. Generally, patients with recurrent biliary obstruction (RBO) after stent placement underwent endoscopic reintervention. Our study outcomes included the technical and functional success rates, RBO rate, time to RBO (TRBO), reintervention rate, and incidence of adverse events. RESULTS: Seventeen patients with unresectable MHBO during complete bilateral intrahepatic cholangiograms underwent endoscopic SBS PCSEMS placement (median age, 78 years; men, 9). Lesions were Bismuth types II (n = 10), III (n = 1), and IV (n = 6), including 10 cholangiocarcinomas, 3 gallbladder cancers, and 4 metastatic cancers. In all patients, the PCSEMS was placed across the duodenal papilla. The technical and functional success rates were 100 % and 82 %, respectively. The median procedure time was 43 minutes (interquartile range [IQR]: 36 - 52 minutes). Twelve patients had RBO (71 %), including 9 stent occlusions due to sludge and 3 stent migrations. The median TRBO was 79 days (IQR: 58 - 156 days) during the follow-up period (median 192 days [IQR: 88 - 551 days]). The median TRBO of patients with Bismuth type II lesions was significantly longer than that of patients with Bismuth types III and IV lesions (87 days [IQR: 70 - 244 days] vs. 54 days [IQR: 35 - 100 days]; P  = 0.030). Thirteen patients (76 %) required endoscopic reintervention. Endoscopic stent removal was possible in 6 patients without tumor ingrowth into the uncovered distal part of the stent. One late adverse event (≥ 31 days) occurred (cholangitis). CONCLUSIONS: Endoscopic SBS placement of a PCSEMS was feasible in patients with unresectable MHBO. Additionally, reinterventional stent removal was possible in the absence of tumor ingrowth.