A novel self-assembling peptide hemostatic gel as rescue therapy for fistula bleeding after endoscopic ultrasound-guided hepaticogastrostomy.

The novel synthetic self-assembling peptide PuraStat has been approved for hemostasis in endoscopic procedures. Nakahara and colleagues describe their application of PuraStat for hemostasis of refractory fistula bleeding after endoscopic ultrasound-guided hepaticogastrostomy. The effective and technically easy procedure is a useful option when hemostasis cannot be achieved by other means.

Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: a multicenter, randomized trial.

BACKGROUND AND AIMS: The efficacy of the suprapapillary placement of inside plastic stents (iPSs) for unresectable malignant hilar biliary obstructions (MHOs) is unknown compared with that of uncovered inside metal stents (iMSs). This randomized controlled trial was designed to evaluate the outcomes of endoscopic placement of these stents for unresectable MHOs. METHODS: This open-label, randomized study was conducted at 12 Japanese institutions. The enrolled patients with unresectable MHOs were allocated to iPS and iMS groups. The primary outcome was defined as the time to recurrent biliary obstruction in patients for whom the intervention was both technically and clinically successful. RESULTS: Among 87 enrollments, 38 patients in the iPS group and 46 patients in the iMS group were analyzed. Technical success rates were 100% (38 of 38) and 96.6% (44 of 46), respectively (P = 1.00). After transferring 1 unsuccessful iMS-group patient to the iPS group (since iPSs were deployed), the clinical success rates were 90.0% (35 of 39) for the iPS group and 88.9% (40 of 45) for the iMS group from a per-protocol analysis (P = 1.00). Among the patients with clinical success, the median times to recurrent biliary obstruction were 250 (95% confidence interval, 85-415) and 361 (95% confidence interval, 107-615) days (log-rank test, P = .34). No differences were detected in rates of adverse events. CONCLUSIONS: This Phase II randomized trial did not show any statistically significant difference in stent patency between suprapapillary plastic versus metal stents. Considering the potential advantages of plastic stents for malignant hilar obstruction, these findings suggest that suprapapillary plastic stents could be a viable alternative to metal stents for this condition.

Clinical outcomes and predictors of technical failure of endoscopic transpapillary gallbladder drainage in acute cholecystitis.

BACKGROUND AND AIMS: Endoscopic transpapillary gallbladder drainage (ETGBD) has been performed as an alternative therapy against cholecystectomy in patients with acute cholecystitis. To date, few studies have reported the safety, efficacy, and factors affecting ETGBD. We evaluated the clinical outcomes and predictors of technical failure of ETGBD. METHODS: Patients with acute cholecystitis who underwent ETGBD were retrospectively reviewed, and consecutive patients were included in the study. The technical success rate, clinical success rate, adverse events, and the predictors associated with the technical failure of ETGBD were investigated. RESULTS: A total of 242 patients were enrolled in the study. The technical success rate of ETGBD and clinical success rate of technically successful ETGBD cases were 87% and 93%, respectively. We experienced cystic duct injury in 24 patients as an ETGBD-related adverse event, and pancreatitis in 12 patients as an endoscopic retrograde cholangiopancreatography-related adverse event. Multivariate analysis indicated that cystic duct injury was the independent predictor associated with the technical failure of ETGBD (odds ratio, 11; 95% confidence interval, 3.9-29; p < 0.001). CONCLUSIONS: ETGBD was a safe and effective treatment method for acute cholecystitis with acceptable adverse events. There was no predictor based on the information from patient characteristics; however, cystic duct injury was associated with the technical failure of ETGBD.

Long-term outcomes of endoscopic transpapillary gallbladder drainage using a novel spiral plastic stent in acute calculus cholecystitis.

BACKGROUND: Endoscopic transpapillary gallbladder stenting (EGBS) is considered for patients with contraindications to early surgery for acute calculus cholecystitis. However, evidence regarding the long-term outcomes of EGBS is insufficient to date. The aim of the study was to evaluate the feasibility of EGBS as a bridge to or alternative to surgery when there are contraindications. METHODS: We reviewed the cases of patients who underwent EGBS using a novel spiral-shaped plastic stent for acute calculus cholecystitis between January 2011 and December 2019. We retrospectively evaluated the long-term outcomes of EGBS using a novel spiral-shaped plastic stent. RESULTS: Forty-nine patients were included. The clinical success rate of EGBS was 97%. After EGBS, 25 patients (surgery group) underwent elective cholecystectomy and 24 patients did not (follow-up group). In the surgery group, the median period from EGBS to surgery was 93 days. There was a single late adverse event with cholecystitis recurrence. In the follow-up group, the median follow-up period was 236 days. Late adverse events were observed in eight patients, including recurrence of cholecystitis (four patients), duodenal penetration by the distal stent end (two patients), and distal stent migration (two patient). In the follow-up group, the time to recurrence of biliary obstruction was 527 days. CONCLUSIONS: EGBS with a novel spiral-shaped plastic stent is safe and effective for long-term acute calculus cholecystitis. There is a possibility of EGBS to be a bridge to surgery and a surgical alternative for acute calculus cholecystitis in patients with contraindications to early cholecystectomy.

Technique of straightening the guidewire using a balloon catheter for successful endoscopic transpapillary gallbladder stenting.

Video 1The technique of straightening the guidewire, looped in the neck of the gallbladder because of segmental adenomyomatosis, using a balloon catheter during endoscopic transpapillary gallbladder stent placement.

Double-guidewire technique for endoscopic transpapillary gallbladder stenting.

Highlight Endoscopic transpapillary gallbladder stenting is effective for acute cholecystitis with high surgical risk. However, looping of the guidewire in the cystic duct sometimes impedes placement of the stent. Nakahara and colleagues present a case of successful endoscopic transpapillary gallbladder stenting after straightening the looped guidewire using a double-guidewire technique.

Incidence and management of cystic duct perforation during endoscopic transpapillary gallbladder drainage for acute cholecystitis.

BACKGROUND AND AIM: Evidence regarding the incidence and clinical outcome of cystic duct perforation (CDP) during endoscopic transpapillary gallbladder drainage (ETGBD) is inadequate. The present study aimed to evaluate the incidence and management of CDP during ETGBD. METHODS: Between March 2011 and December 2019, 249 patients underwent initial ETGBD for acute cholecystitis. The incidence of CDP was retrospectively examined and the outcomes between the CDP and non-CDP groups were compared. RESULTS: CDP during ETGBD occurred in 23 (9.2%) of 249 patients (caused by guidewire in 15 and cannula in 8). ETGBD was successful in 10 patients following CDP. In 13 patients who failed ETGBD, 11 underwent bile duct drainage during the same session; nine patients underwent gallbladder decompression by other methods, such as percutaneous drainage. Clinical resolution for acute cholecystitis was achieved in 20 patients, and no bile peritonitis was noted. ETGBD technical success rates (45.3% vs. 91.2%, p < 0.001), ETGBD procedure times (66.5 vs. 54.8 min, p = 0.041), and hospitalization periods (24.5 vs. 18.7 days, p = 0.028) were significantly inferior in the CDP group (n = 23) compared with the non-CDP group (n = 216). There were no differences in clinical success and adverse events other than CDP between both groups. CONCLUSIONS: Cystic duct perforation reduced the ETGBD technical success rate. However, even in patients with cystic duct perforation, an improvement of acute cholecystitis was achieved by subsequent successful ETGBD or additional procedures, such as percutaneous drainage.

Efficacy of endoscopic large balloon dilation extended for 2 minutes in bile duct stone removal: A multicenter retrospective study.

BACKGROUND/PURPOSE: There is no evidence regarding the optimal balloon dilation time during endoscopic papillary large balloon dilation (EPLBD). The study aim was to evaluate the efficacy of 2-minute extended balloon dilation for EPLBD. METHODS: Two hundred and five patients who underwent EPLBD during endoscopic retrograde cholangiopancreatography (ERCP) for bile duct stones at three tertiary centers were included in the analysis. Clinical outcomes and the adverse events were compared between the 0-minute group (n = 94, balloon deflated immediately after waist disappearance) and the 2-minute group (n = 111, balloon dilation maintained for 2 minutes after waist disappearance). The risk factors of post-ERCP pancreatitis (PEP) after EPLBD were assessed. RESULTS: There were no significant differences in the stone removal rates and hospitalization periods between the two groups. However, the total ERCP procedure time was significantly shorter in the 2-minute group (40.6 vs 48.9 min, P = .03). The incidence of PEP was 7.4% in the 0-minute group and significantly lower at 0.9% in the 2-minute group (P = .04). Multivariate analysis identified without 2-minute extended EPLBD as a significant risk factor of PEP (OR: 9.9, P = .045). CONCLUSIONS: Extension of EPLBD for 2 minutes helped prevent PEP and shortened the procedure time.

The Influence of Pre-Procedural Imaging and Cystic Duct Cholangiography on Endoscopic Transpapillary Gallbladder Drainage in Acute Cholecystitis.

Endoscopic transpapillary gallbladder drainage (ETGBD) for acute cholecystitis is challenging. We evaluated the influence of pre-procedural imaging and cystic duct cholangiography on ETGBD. Patients who underwent ETGBD for acute cholecystitis were retrospectively examined. The rate of gallbladder contrast on cholangiography, the accuracy of cystic duct direction and location by computed tomography (CT) and magnetic resonance cholangiopancreatography (MRCP), and the relationship between pre-procedural imaging and the technical success of ETGBD were investigated. A total of 145 patients were enrolled in this study. Gallbladder contrast on cholangiography was observed in 29 patients. The accuracy of cystic duct direction and location (proximal or distal, right or left, and cranial or caudal) by CT were, respectively, 79%, 60%, and 58% by CT and 68%, 55%, and 58% by MRCP. Patients showing gallbladder contrast on cholangiography underwent ETGBD with a significantly shorter procedure time and a lower rate of cystic duct injury. No other factors affecting procedure time, technical success, and cystic duct injury were identified. Pre-procedural evaluation of cystic duct direction and location by CT or MRCP was difficult in patients with acute cholecystitis. Patients who showed gallbladder contrast on cholangiography showed a shorter procedure time and a lower rate of cystic duct injury.

Clinical Outcomes of Early Endoscopic Transpapillary Biliary Drainage for Acute Cholangitis Associated with Disseminated Intravascular Coagulation.

Acute cholangitis (AC) is often associated with disseminated intravascular coagulation (DIC), and endoscopic transpapillary biliary drainage (EBD) under endoscopic retrograde cholangiopancreatography (ERCP) is a treatment of choice. However, no evidence exists on the outcomes of EBD for AC associated with DIC. Therefore, we retrospectively evaluated the treatment outcomes of early EBD and compared endoscopic biliary stenting (EBS) and endoscopic nasobiliary drainage (ENBD). We included 62 patients who received early EBD (EBS: 30, ENBD: 32) for AC, associated with DIC. The rates of clinical success for AC and DIC resolution at 7 days after EBD were 90.3% and 88.7%, respectively. Mean hospitalization period was 31.7 days, and in-hospital mortality rate was 4.8%. ERCP-related adverse events developed in 3.2% of patients (bleeding in two patients). Comparison between EBS and ENBD groups showed that the ENBD group included patients with more severe cholangitis, and acute physiology and chronic health evaluation II score, systemic inflammatory response syndrome score, and serum bilirubin level were significantly higher in this group. However, no significant difference was observed in clinical outcomes between the two groups; both EBS and ENBD were effective. In conclusion, early EBD is effective and safe for patients with AC associated with DIC.

Pancreatic duct guidewire placement for biliary cannulation as a risk factor for stone residue after endoscopic transpapillary stone removal.

BACKGROUND: Recent improvements in stone extraction implements and apparatus have lessened the complexity of the endoscopic bile duct stone treatment. However, despite confirmation of complete removal, cases of residual stones have been reported, which can result in recurrent biliary symptoms, cholangitis, and pancreatitis and considerably increase cost given the need for repeat imaging and/or procedures. To date, risk factors for residual bile duct stones following endoscopic retrograde cholangiopancreatography (ERCP) extraction have not been thoroughly evaluated. This study retrospectively investigated the incidence and risk factors of residual bile duct stones following extraction via ERCP. METHODS: We retrospectively reviewed all ERCP cases that underwent endoscopic bile duct stone extraction between April 2014 and March 2019. A total of 505 patients were enrolled and evaluated for the incidence and risk factors of residual bile duct stones after ERCP. RESULTS: The rate of residual stones was 4.8% (24/505). Residual stones were detected by computed tomography (12/24) or magnetic resonance cholangiopancreatography (12/24). In univariate analyses, a large number of stones (P = 0.01), long procedure time (P = 0.005), and performance of the pancreatic duct guidewire placement method (P-GW) for selective bile duct cannulation (P = 0.01) were the factors involved in residual stones. In multiple logistic regression analysis, performing P-GW was retained as the only independent factor of residual stones (adjusted odds ratio, 3.44; 95% CI, 1.19-9.88; P = 0.02). CONCLUSIONS: When removing bile duct stones with a pancreatic guidewire in place, paying attention to residual stones is necessary.

Use of washing cytology from removed self-expandable metal stents for biliary strictures: a novel cytology method.

Removability is one of the important features of biliary covered self-expandable metal stents (CSEMS). In this study, we evaluated the diagnostic ability of washing cytology of removed CSEMS. For 14 removed CSEMS that had been placed for the biliary strictures (12 malignant, 2 benign), the surface of CSEMS was washed with saline, and pathological examination of the washing liquid as cytology (CSEMS washing cytology) was performed. The specimen sampling rates and sensitivity for malignancy of CSEMS washing cytology were 92.9 % and 41.7 %, respectively. Sensitivity according to the primary disease was 60.0 % for bile duct cancer and 20 % for pancreatic cancer. Sensitivities based on the methods of stent removal were 16.7 % and 66.7 % for removal through the channel of the scope and with the scope, respectively. Therefore, it is possible that sensitivity of CSEMS washing cytology is higher in bile duct cancer and for removal with the scope. In conclusion, CSEMS washing cytology may have potential as a pathological diagnostic method.

Endoscopic Transpapillary Gallbladder Drainage for Acute Cholecystitis After Biliary Self-Expandable Metal Stent Placement.

BACKGROUND: Endoscopic transpapillary gallbladder drainage (ETGBD) for acute cholecystitis (AC) after self-expandable metal stent (SEMS) placement is technically challenging and there are no reports about its outcome in a several cases. This study aims to assess the outcomes of ETGBD for AC after SEMS placement. METHODS: Between April 2011 and April 2019, 314 patients underwent SEMS placement for biliary stricture. Among them, 12 of 21 patients who developed AC after SEMS placement underwent ETGBD. In general, ETGBD was performed after SEMS removal in cases in which a covered SEMS was previously placed or with the SEMS kept in place in cases in which an uncovered SEMS was previously placed. When the orifice of the cystic duct overlapped the uncovered SEMS, ETGBD was performed through the mesh of the SEMS. RESULTS: Among the 12 patients who underwent ETGBD, the previously placed SEMS was in the distal (n=8) or perihilar (n=4) bile duct. The type of SEMS placed in the distal bile duct was covered in 7 (fully covered: 6, partially covered: 1) and uncovered in 1, whereas that in the perihilar bile duct was uncovered for all. The technical success rate of ETGBD was 83.3% (10/12), and that according to the previous SEMS placement site was 75.0% (6/8) for the distal bile duct and 100% (4/4) for the perihilar bile duct. In the technically successful, the clinical success rate for AC was 90.0% (9/10). The rate of adverse event was 16.7% (2/12) (stent kink: 1, tube self-removal: 1). CONCLUSIONS: ETGBD can have relatively good outcomes for AC after SEMS placement.