Safety of biliary drainage with 6-mm metallic stent for preoperative obstructive jaundice in pancreatic cancer: PURPLE SIX STUDY.

BACKGROUND AND AIM: The 10-mm self-expandable metal stent (SEMS) is the standard for endoscopic transpapillary biliary drainage before pancreatic cancer surgery. However, the efficacy of stents thinner than 10 mm has not been adequately validated. Therefore, we aimed to evaluate the safety of a 6-mm fully covered SEMS (FCSEMS) for distal malignant biliary obstruction (DMBO) during preoperative chemotherapy for pancreatic cancer. METHODS: This was a single-arm, multicenter, prospective phase II study of endoscopic transpapillary initial biliary drainage for DMBO before pancreatic cancer surgery. The primary endpoint was stent-related adverse events, and the key secondary endpoint was the non-recurrent biliary obstruction (non-RBO) rate during the observation period for both resectable (R) and borderline resectable (BR) pancreatic cancers. RESULTS: The study enrolled 33 patients, among whom 32 received the study treatment. There were 23 and 9 cases of R and BR pancreatic cancers, respectively. The technical and clinical success rates were 97.0% and 90.1%, respectively. The stent-related adverse event rate was 3.1% (n = 1, acute pancreatitis) (95% confidential interval, 0.00-16.2), which met the criteria to be considered safe. The overall non-RBO rate during the observation period (median 96 days) was 78.1% (82.6% and 66.7% for R and BR pancreatic cancer cases, respectively). CONCLUSIONS: The 6-mm FCSEMS is an extremely safe metallic stent with a low stent-related adverse event rate of 3.1% for preoperative biliary drainage in pancreatic cancer. It is considered the optimal stent for preoperative biliary drainage in terms of the non-RBO rate. UMIN Clinical Trial Registry (UMIN-CTR 000041704).

Transluminal antegrade drill dilation technique for hepaticojejunostomy stricture with cholangioscopic evaluation (with video).

Background and study aims Balloon dilation and plastic stent deployment have been performed as hepaticojejunostomy stricture (HJS) treatment techniques under endoscopic ultrasound guidance (EUS). Although these techniques have shown favorable clinical results, the treatment period can be long because stent deployment is required. In addition, HJS may recur even after treatment because the scar tissue itself remains. To overcome these challenges, we developed an EUS-guided antegrade drill dilation technique for treating HJS. The aim of this study was to evaluate the technical feasibility and safety of this technique in terms of the pre- and post-cholangioscopic findings. Patients and methods This retrospective study included consecutive patients whose conditions were complicated with symptomatic HJS between November 2022 and February 2023. Transluminal antegrade drill dilation (TAD) using a novel drill dilator was attempted within 14 days after EUS-guided hepaticogastrostomy (HGS). HJS was diagnosed with cholangioscopy before TAD, and resolution was evaluated after TAD using cholangioscopy. Results TAD was attempted at approximately 11 days after EUS-HGS. The cholangioscope was inserted successfully in all patients after this procedure. Cholangioscopy revealed stricture without evidence of malignancy in 19 patients. In the remaining three patients, stricture was not observed and these patients underwent stent exchange rather than TAD. Among the 19 patients, passage of the guidewire across the HJS into the intestine was unsuccessful in four patients, and the technical success rate for this procedure was 78.9%. TAD was successful in all 15 patients in whom passage of the guidewire was achieved. Conclusions In conclusion, TAD appears to be technically feasible and safe.

Evaluation of exclusive internal endoscopic drainage for complex biloma with transluminal and transpapillary stenting.

Background and study aims Biloma is treated endoscopically with endoscopic retrograde cholangiography (ERCP) or endoscopi ultrasound-guided transluminal biloma drainage (EUS-TBD). However, almost all previous studies have used both internal and external drainage. External drainage has the disadvantages of poor cosmetic appearance and self-tube removal. The aim of the present study was to evaluate the internal endoscopic drainage for complex biloma after hepatobiliary surgery with an ERCP- or EUS-guided approach, without external drainage. Patients and methods This retrospective study included consecutive patients who had bilomas. A 7F plastic stent was deployed from the biloma to the duodenum in the ERCP group and the metal stent was deployed from the biloma to the stomach in the EUS-TBD group. Results Forty-seven patients were enrolled. The technical success rate was similar between the groups (ERCP 94% vs EUS-TBD 100%, P =0.371); however, mean procedure time was significantly shorter in the EUS-TBD group (16.9 minutes) than in the ERCP group (26.6 minutes) ( P =0.009). The clinical success rate was 87% (25 of 32 patients) in the ERCP group and 84% (11 of 13 patients) in the EUS-TBD group ( P =0.482). The duration of median hospital stay was significantly shorter in the EUS-TBD group (22 days) than in the ERCP group (46 days) ( P =0.038). There was no significant difference in procedure-associated adverse events between the groups. Conclusions In conclusion, ERCP and EUS-TBD are complementary techniques, each with its own merits in specific clinical scenarios. If both techniques can be performed, EUS-TBD should be considered because of the short times for the procedure, hospital stay. and biloma resolution.

Endoscopic ultrasound-guided hepaticogastrostomy versus hepaticogastrostomy with antegrade stenting in patients with unresectable malignant distal biliary obstruction: a propensity score-matched case-control study.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a rescue procedure when endoscopic retrograde cholangiopancreatography fails. Peritonitis and recurrent biliary obstruction (RBO) are adverse events (AEs) associated with EUS-HGS. Antegrade stenting across a malignant distal biliary obstruction (MDBO) followed by EUS-HGS (EUS-HGAS) creates two biliary drainage routes, potentially reducing peritonitis and prolonging time to RBO (TRBO). We compared the outcomes of the two techniques. METHODS: Data of consecutive patients with MDBO who underwent attempted EUS-HGS or EUS-HGAS across five institutions from January 2014 to December 2020 were retrospectively analyzed. A matched cohort of the patients was obtained using one-to-one propensity score matching. The primary outcome was TRBO, and secondary outcomes included AEs except for RBO and overall survival (OS). RESULTS: Among 360 patients, 283 (176 and 107 in the HGS and HGAS groups, respectively) were eligible. The matched cohorts included 81 patients in each group. AEs developed in 10 (12.3%) and 15 (18.5%) patients (p=0.38) in the HGS and HGAS groups, respectively. RBO occurred in 18 and 2 patients in the HGS and HGAS groups, respectively (p<0.001). TRBO was significantly longer in the HGAS group (median 194 vs. 716 days; hazard ratio [HR]=0.050, 95% confidence interval [CI]=0.0066-0.37, p<0.01). However, there was no significant difference in OS between the groups (median 97 vs. 112 days; HR=0.97, 95% CI=0.66-1.4, p=0.88). CONCLUSIONS: EUS-HGAS extended TRBO compared with EUS-HGS, while AEs, except for RBO and OS, did not differ. The longer TRBO of EUS-HGAS could benefit patients with longer life expectancy.

ERCP using balloon-assisted endoscopes versus EUS-guided treatment for common bile duct stones in Roux-en-Y gastrectomy.

BACKGROUND AND AIMS: We compared ERCP using a balloon-assisted endoscope (BE-ERCP) with EUS-guided antegrade treatment (EUS-AG) for removal of common bile duct (CBD) stones in patients with Roux-en-Y (R-Y) gastrectomy. METHODS: Consecutive patients who had previous R-Y gastrectomy undergoing BE-ERCP or EUS-AG for CBD stones in 16 centers were retrospectively analyzed. RESULTS: BE-ERCP and EUS-AG were performed in 588 and 59 patients, respectively. Baseline characteristics were similar, except for CBD diameter and angle. The technical success rate was 83.7% versus 83.1% (P = .956), complete stone removal rate was 78.1% versus 67.8% (P = .102), and early adverse event rate was 10.2% versus 18.6% (P = .076) in BE-ERCP and EUS-AG, respectively. The mean number of endoscopic sessions was smaller in BE-ERCP (1.5 ± .8 vs 1.9 ± 1.0 sessions, P = .01), whereas the median total treatment time was longer (90 vs 61.5 minutes, P = .001). Among patients with biliary access, the complete stone removal rate was significantly higher in BE-ERCP (93.3% vs 81.6%, P = .009). Negative predictive factors were CBD diameter ≥15 mm (odds ratio [OR], .41) and an angle of CBD <90 degrees (OR, .39) in BE-ERCP and a stone size ≥10 mm (OR, .07) and an angle of CBD <90 degrees (OR, .07) in EUS-AG. The 1-year recurrence rate was 8.3% in both groups. CONCLUSIONS: Effectiveness and safety of BE-ERCP and EUS-AG were comparable in CBD stone removal for patients after R-Y gastrectomy, but complete stone removal after technical success was superior in BE-ERCP.

Adverse events of self-expandable metal stent placement for malignant distal biliary obstruction: a large multicenter study.

BACKGROUND AND AIMS: Endoscopic placement of self-expandable metal stents (SEMSs) for malignant distal biliary obstruction (MDBO) may be accompanied by several types of adverse events. The present study analyzed the adverse events occurring after SEMS placement for MDBO. METHODS: The present study retrospectively investigated the incidence and types of adverse events in patients who underwent SEMS placement for MDBO between April 2018 and March 2021 at 26 hospitals. Risk factors for acute pancreatitis, cholecystitis, and recurrent biliary obstruction (RBO) were evaluated by univariate and multivariate analyses. RESULTS: Of the 1425 patients implanted with SEMSs for MDBO, 228 (16.0%) and 393 (27.6%) experienced early adverse events and RBO, respectively. Pancreatic duct without tumor involvement (P = .023), intact papilla (P = .025), and SEMS placement across the papilla (P = .037) were independent risk factors for acute pancreatitis. Tumor involvement in the orifice of the cystic duct was an independent risk factor for cholecystitis (P < .001). Use of fully and partially covered SEMSs was an independent risk factor for food impaction and/or sludge. Use of fully covered SEMSs was an independent risk factor for stent migration. Use of uncovered SEMSs and laser-cut SEMSs was an independent risk factor for tumor ingrowth. CONCLUSIONS: Pancreatic duct without tumor involvement, intact papilla, and SEMS placement across the papilla were independent risk factors for acute pancreatitis, and tumor involvement in the orifice of the cystic duct was an independent risk factor for cholecystitis. The risk factors for food impaction and/or sludge, stent migration, and tumor ingrowth differed among types of SEMSs.

Moving scope technique improves technical success rate of device insertion during EUS-guided hepaticogastrostomy (with video).

Background: Technical tips for device insertion during endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) have not been reported. To improve the technical success rate of device insertion without unnecessary tract dilation, the pushing force should be transmitted directly from the channel of the echoendoscope to the intrahepatic bile duct. Objectives: We developed a novel technique, termed the 'moving scope technique', the feasibility of which during EUS-HGS is described. Design: Retrospective study. Methods: The primary outcome of this study was the technical success rate of dilation device insertion without electrocautery dilation after the moving scope technique. The initial technical success rate of dilation device insertion was defined as successful insertion into the biliary tract. If dilation device insertion failed, the moving scope technique was attempted. Results: A total of 143 patients were enrolled in this study. The initial technical success rate for device insertion was 80.4% (115/143). The moving scope technique was therefore attempted in 28 patients. The mean angle between the intrahepatic bile duct and the guidewire was improved to 141.0° and resulted in a technical success rate of 100% (28/28). The area under the ROC curve (AUC) was 0.88, and 120° predicted successful dilation device insertion with sensitivity of 88.0% and specificity of 78.8%. Bile peritonitis (n = 8) and cholangitis (n = 2) were observed as adverse events, but were not severe. Conclusion: In conclusion, the moving scope technique may be helpful during EUS-HGS to achieve successful insertion of the dilation device into the biliary tract. These results should be evaluated in a prospective randomized controlled trial.

Endoscopic nasobiliary drainage versus endoscopic biliary stenting for preoperative biliary drainage in patients with malignant hilar biliary obstruction: Propensity score-matched multicenter comparative study.

OBJECTIVES: For preoperative biliary drainage (PBD) of malignant hilar biliary obstruction (MHBO), current guidelines recommend endoscopic nasobiliary drainage (ENBD) due to the higher risk of cholangitis after endoscopic biliary stenting (EBS) during the waiting period before surgery. However, few studies have supported this finding. Therefore, we aimed to compare the outcomes of preoperative ENBD and EBS in patients with MHBO. METHODS: Patients with MHBO who underwent laparotomy for radical surgery after ENBD or EBS were included from retrospectively collected data from 13 centers (January 2014 to December 2018). We performed a 1:1 propensity score matching between the ENBD and EBS groups. These patients were compared for the following: cholangitis and all adverse events (AEs) after endoscopic biliary drainage (EBD) until surgery, time to cholangitis development after EBD, postsurgical AEs, and in-hospital death after surgery. RESULTS: Of the 414 patients identified, 355 were analyzed in this study (226 for ENBD and 129 for EBS). The matched cohort included 63 patients from each group. The proportion of cholangitis after EBD was similar between the two groups (20.6% vs. 25.4%, P = 0.67), and no significant difference was observed in the time to cholangitis development. The proportions of surgical site infections, bile leaks, and in-hospital mortality rates were similar between the groups. CONCLUSION: For PBD of MHBO, the proportion of AEs, including cholangitis, after EBD until surgery was similar when either ENBD or EBS was used.

Liver impaction technique improves technical success rate of guidewire insertion during EUS-guided hepaticogastrostomy (with video).

Background: If the guidewire becomes kinked by the needle, guidewire manipulation may be difficult, and can cause complications such as guidewire shearing or injury during endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS). To overcome this matter, we have previously described a technical tip for preventing guidewire injury, termed 'liver impaction technique'. However, its technical feasibility has been not reported in the setting of a large patient cohort. Objectives: The aim of study was to evaluate the clinical usefulness of the liver impaction technique during EUS-HGS. Design: Retrospective, single-center study. Methods: This retrospective study included consecutive patients who underwent EUS-HGS between April 2018 and September 2022. The primary outcome of this study was the technical success rate of guidewire insertion using the liver impaction technique. Results: A total of 166 patients were enrolled in this study. Initial successful guidewire insertion without using liver impaction technique was obtained in 108 patients (65.1%). Among 58 patients in whom guidewire insertion failed initially, guidewire advancement into the periphery of the bile duct was observed in 32 patients (55.2%) and into a non-interest bile duct branch was observed in 26 patients (44.8%). Liver impaction technique contributed to increasing the technical success rate of guidewire insertion from 65.1% to 95.8%. Overall, adverse events were observed in 12 patients (7.2%; bile peritonitis n = 9, cholangitis n = 3), and these adverse events were Grade I. Among patients who underwent liver impaction technique (n = 58), adverse events were observed in two patients (3.4%; bile peritonitis). Also, guidewire sharing was not observed in any patients during liver impaction technique. Conclusions: In conclusion, the liver impaction technique may be helpful during EUS-HGS to obtain successful guidewire insertion into the biliary tract of interest.