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.

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).

EUS-guided hepaticogastrostomy versus EUS-guided hepaticogastrostomy with antegrade stent placement in patients with unresectable malignant distal biliary obstruction: a propensity score-matched case-control study.

BACKGROUND AND AIMS: EUS-guided hepaticogastrostomy (EUS-HGS) is a rescue procedure when ERCP fails. Peritonitis and recurrent biliary obstruction (RBO) are adverse events (AEs) associated with EUS-HGS. Antegrade stent placement across a malignant distal biliary obstruction (DBO) followed by EUS-HGS (EUS-HGAS) creates 2 biliary drainage routes, potentially reducing peritonitis and prolonging time to RBO (TRBO). We compared the outcomes of the 2 techniques. METHODS: Data of consecutive patients with malignant DBO who underwent attempted EUS-HGS or EUS-HGAS across 5 institutions from January 2014 to December 2020 were retrospectively analyzed. A matched cohort of patients was obtained using 1-to-1 propensity score matching. The primary outcome was TRBO, and secondary outcomes were AEs except for RBO and overall survival. 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 = .38) in the HGS and HGAS groups, respectively. RBO occurred in 18 and 2 patients in the HGS and HGAS groups, respectively (P < .001). TRBO was significantly longer in the HGAS group (median, 194 days vs 716 days; hazard ratio, .050; 95% confidence interval, .0066-.37; P < .01). However, no significant differences occurred in overall survival between the groups (median, 97 days vs 112 days; hazard ratio, .97; 95% confidence interval, .66-1.4; P = .88). CONCLUSIONS: EUS-HGAS extended TRBO compared with EUS-HGS, whereas AEs, except for RBO and overall survival, did not differ. The longer TRBO of EUS-HGAS could benefit patients with longer life expectancy.

Propensity score matching analysis for clinical impact of braided-type versus laser-cut-type covered self-expandable metal stents for endoscopic ultrasound-guided hepaticogastrostomy.

BACKGROUND: To prevent stent migration during endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS), intra-scope channel release technique is important, but is unfamiliar to non-expert hands. The self-expandable metal stent (SEMS) is an additional factor to prevent stent migration. However, no comparative studies of laser-cut-type and braided-type during EUS-HGS have been reported. The aim of this study was to compare the distance between the intrahepatic bile duct and stomach wall after EUS-HGS among laser-cut-type and braided-type SEMS. METHODS: To evaluate stent anchoring function, we measured the distance between the hepatic parenchyma and stomach wall before EUS-HGS, one day after EUS-HGS, and 7 days after EUS-HGS. Also, propensity score matching was performed to create a propensity score for using laser-cut-type group and braided-type group. RESULTS: A total of 142 patients were enrolled in this study. Among them, 24 patients underwent EUS-HGS using a laser-cut-type SEMS, and 118 patients underwent EUS-HGS using a braided-type SEMS. EUS-HGS using the laser-cut-type SEMS was mainly performed by non-expert endoscopists (n = 21); EUS-HGS using braided-type SEMS was mainly performed by expert endoscopists (n = 98). The distance after 1 day was significantly shorter in the laser-cut-type group than that in the braided-type group [2.00 (1.70-3.75) vs. 6.90 (3.72-11.70) mm, P < 0.001]. In addition, this distance remained significantly shorter in the laser-cut-type group after 7 days. Although these results were similar after propensity score matching analysis, the distance between hepatic parenchyma and stomach after 7 days was increased by 4 mm compared with the distance after 1 day in the braided-type group. On the other hand, in the laser-cut-type group, the distance after 1 day and 7 days was almost the same. CONCLUSIONS: EUS-HGS using a laser-cut-type SEMS may be safe to prevent stent migration, even in non-expert hands.

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.

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.

Clinical evaluation of a novel drill dilator as the first-line tract dilation technique during EUS-guided biliary drainage by nonexpert hands (with videos).

BACKGROUND AND AIMS: In cases in which tract dilation fails using the initially selected dilation device during EUS-guided hepaticogastrostomy (EUS-HGS), dilation should be re-attempted using another device. However, switching from one device to another during the procedure is often associated with prolonged procedure time and deviation from the correct axis. Therefore, it is highly desired that the initial tract dilation succeeds on the first attempt. Recently, a novel drill dilator has become available in Japan. Because there have been no previous studies comparing this novel device versus others as an initial dilation device, this article reports on the technical feasibility of this novel device for use during EUS-HGS and compares it with a balloon catheter. METHODS: This retrospective study included patients who underwent EUS-HGS using a self-expandable metal stent between October 2021 and October 2022. Excluded from the study were patients who underwent EUS-HGS using a plastic stent or stent deployment without tract dilation. The primary outcome in this study was the technical success rate of initial tract dilation using the drill dilator. This dilator has been available at our hospital since June 2022. Thus, EUS-HGS was performed using this device as the primary dilation device from June 2022 to October 2022. As the control group, we corrected patients who underwent EUS-HGS using a 4-mm balloon catheter as the primary dilation device from October 2021 to May 2022. RESULTS: A total of 49 patients were included: 19 underwent EUS-HGS using the drill dilator and 30 underwent EUS-HGS using a balloon catheter. EUS-HGS using the drill dilator initially was performed mainly by nonexpert hands (n = 19), whereas only some procedures in the balloon catheter group were performed by nonexpert hands (n = 2). Although the initial tract dilation was successful in all patients in the drill dilator group (19 of 19 [100%]) and in 29 (97%) of 30 in the balloon catheter group, additional tract dilation was needed in 73.7% (14 of 19) of the drill dilator group upon insertion of the 8.5F stent delivery system. In contrast, the stent delivery system insertion was successful without additional tract dilation in all patients in the balloon catheter group. CONCLUSIONS: The novel drill dilator might be useful as a dilation device; however, the balloon dilation technique should be selected first upon deploying a dedicated metal stent with an 8.5F stent delivery system.

Prospective registration study of diagnostic yield and sample size in forceps biopsy using a novel device under digital cholangioscopy guidance with macroscopic on-site evaluation.

BACKGROUND: Although the SpyGlass Direct Visualization System can be clinically useful for diagnosing indeterminate biliary stricture, it employs SpyBite forceps, which typically obtain only a small amount of tissue and have a low sampling rate. An improved forceps biopsy device for SpyGlass DS has recently been released (SpyBite MAX). The aim of this prospective registration study was to assess the diagnostic yield and efficacy of histological biopsy tissue obtained with SpyBite MAX forceps compared with SpyBite forceps in patients with indeterminate biliary stricture. METHODS: The primary outcome of the study was the diagnostic accuracy of biopsy specimens obtained by SpyBite MAX forceps. The secondary outcomes were tissue size, number of forceps biopsies, rate of obtaining adequate tissue, and adverse events in the SpyBite MAX forceps group compared with the SpyBite group. RESULTS: Forceps biopsies using SpyBite MAX (n = 47) and SpyBite (n = 50) were performed successfully in all patients. The number of biopsies performed before visible core tissue was obtained was significantly lower in the SpyBite (mean, 1.5 ± 0.7) than in the SpyBite forceps group (mean, 2.3 ± 1.1 mm; P < .001). Tissue sample size was larger in the SpyBite MAX group (mean, 1.8 ± 1.6 mm2 ) than in the SpyBite group (mean, 1.0 ± 0.9 mm2 ; P = .004) but there was no significant difference in diagnostic accuracy. CONCLUSION: Improvements in dedicated forceps for biopsy in SpyGlass DS may contribute to improving the rates of adequate tissue and tissue sample size obtained, and to reducing the number of forceps biopsies required.