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.

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 comparison study between 19-gauge needle with .025-inch guidewire and 22-gauge needle with novel .018-inch guidewire during EUS-guided transhepatic biliary drainage (with video).

BACKGROUND AND AIMS: If the diameter of the intrahepatic bile duct is much less dilated, bile duct puncture with a 19-gauge needle can be challenging during EUS-guided biliary drainage (EUS-BD). These characteristics can decrease the difficulty of bile duct puncture, but use of a 22-gauge needle is less feasible because of poor visibility, maneuverability, and stiffness of the conventional .018-inch guidewire. A novel, improved .018-inch guidewire has recently become available. We conducted a prospective study to evaluate the technical feasibility and safety of EUS-BD in patients with insufficient bile duct dilatation using a 22-gauge needle and the new .018-inch guidewire. METHODS: A 22-gauge needle was used as the puncture needle for intrahepatic bile ducts of diameters <1.5 mm, and a 19-gauge needle was selected for diameters ≥1.5 mm. As the primary endpoint of the study, the technical success rate of EUS-BD using a 22-gauge needle with the novel .018-inch guidewire was evaluated in patients with insufficient dilation of the intrahepatic bile duct. RESULTS: Forty-one patients who required EUS-BD were enrolled (22-gauge needle group, n = 18; 19-gauge needle group, n = 23). Technical success was obtained in all patients in the 19-gauge needle group. In the 22-gauge needle group, technical failure occurred in 2 patients because of nonidentification of the intrahepatic bile duct on EUS (technical success rate, 88.9%), and puncture of the bile duct itself was not performed in these patients. Mean procedure time was similar between the groups. Adverse events were observed in 16.7% of patients (3/16) in the 22-gauge needle group and in 34.8% of patients (8/23) in the 19-gauge needle group. CONCLUSIONS: Outcomes of using a 22-gauge needle with a novel .018-inch guidewire were comparable with a 19-gauge needle with a .025-inch guidewire, even in the case of insufficient intrahepatic bile duct dilatation. These results require verification in a prospective, randomized trial comparing 22-gauge and 19-gauge needles with a larger sample size. (Clinical trial registration number: UMIN000044441.).

Transluminal intrahepatic bile duct stone removal using a novel spiral basket catheter via the endoscopic ultrasound-guided hepaticogastrostomy route (with video).

Recently, endoscopic ultrasound (EUS)-guided biliary drainage has been developed as an alternative biliary drainage technique for failed endoscopic retrograde cholangiopancreatography (ERCP) or inaccessible papilla. Among the various EUS-guided biliary drainage procedures, EUS-guided hepaticogastrostomy (HGS) can be performed in patients with surgically altered anatomy. More recently, various transluminal treatments have been described after EUS-HGS, such as antegrade stone removal. In patients with hepaticojejunostomy strictures, stone extraction into the intestine might be challenging even after performing hepaticojejunostomy stricture dilation using a balloon catheter. In such cases, transluminal stone removal is considered an alternative method. With transluminal stone removal, a small stone that escapes from the conventional basket or from a balloon catheter could migrate into the branch bile ducts. The novel spiral basket catheter available in Japan. The wires form a helix shape, wherein each wire is wound counterclockwise, and the winding pitch becomes gradually tighter from the proximal portion to the tip. As the winding pitch is smaller and the wires are in closer contact with the bile duct wall as compared with conventional basket catheter, small bile duct stones can be easily captured by simply pulling back the catheter while the basket is open. In addition, even during withdrawal inside the bile duct, a high retrieval performance is assured by the special design that maintains the opening width on the top end. Therefore, transluminal stone removal using this novel basket catheter might be clinically useful, although further prospective evaluation of a larger number of cases is needed.

Expanding indications for endoscopic ultrasound-guided hepaticogastrostomy for patients with insufficient dilatation of the intrahepatic bile duct using a 22G needle combined with a novel 0.018-inch guidewire (with video).

A prerequisite for endoscopic ultrasound (EUS)-guided hepaticogastrostomy (HGS) is adequate dilation of the intrahepatic bile duct. Compared with a 19G needle, the 22G needle offers more flexible manipulation and superior ability to achieve bile duct puncture. However, evidence regarding EUS-HGS using a 22G needle remains limited. The present study evaluated the feasibility and safety of EUS-HGS using a novel 0.018-inch guidewire and 22G needle for patients with insufficient intrahepatic bile duct dilation. If the bile duct diameter was <1.5 mm, a 22G needle was used, and the diameter was ≥1.5 mm; puncture with a 19G needle was first attempted, with the 22G needle being inserted if initial bile duct puncture failed. EUS-HGS using the 22G needle was attempted in a total of 10 patients, including one patient with failed insertion of a 19G needle. Median diameter of the puncture site was 1.2 mm (range 0.5-2.5 mm). Bile duct puncture using the 22G needle was successful in all patients. Insertion of the novel 0.018-inch guidewire was also successful in all patients. However, since tract dilation using an ultra-tapered mechanical dilator failed in two patients, tract dilation was performed using a balloon dilator. Finally, stent deployment was successfully performed in all patients. EUS-HGS using a 22G needle with a novel 0.018-inch guidewire appears safe and feasible.

Novel transluminal treatment protocol for hepaticojejunostomy stricture using covered self-expandable metal stent.

BACKGROUND: Hepaticojejunostomy anastomotic stricture (HJS) is a rare complication after pancreatoduodenostomy. However, the rate of HJS may be increased with the expansion of operative indications, such as intraductal papillary mucinous neoplasm. Recently, the indications for EUS-guided biliary drainage to treat benign biliary disease have expanded. Recently, novel transluminal treatment protocol has been established in our hospital. The aim of this study was thus to evaluate the technical feasibility and safety of our treatment protocol. PATIENTS AND METHOD: Consecutive patients with complications of HJS between January and December 2018 were enrolled in this study. EUS-guided hepaticogastrostomy (HGS) is firstly performed. After 7 days to create the fistula, HGS stent is removed. HJS is transluminally evaluated by a cholangioscope, and antegrade balloon dilation is attempted. After 3 months, if HJS is still presence, antegrade stent deployment is performed using a covered metal stent. Also, after 1 month, antegrade stent removal is transluminally performed. RESULTS: Among total 29 patients, 14 patients were underwent antegrade metal stent deployment. The technical success rate of antegrade stent deployment was 92.9%. Median period of stent placement was 30.5 days (range 28-38 days), and transluminal stent removal was successfully performed in all patients. During follow-up (median 278 days; range 171-505 days), recurrence of HJS was seen in 2 patients. Severe adverse events were not seen in any patients during follow-up period. CONCLUSION: Transluminal stent deployment for HJS under EUS-guidance appears feasible and safe, although further study with a larger sample size and longer follow-up is warranted.

Antiplatelet and/or anticoagulant treatment does not increase hemorrhagic adverse events during EUS-guided biliary drainage.

BACKGROUND AND AIMS: No data appear to have been reported regarding bleeding risk among patients receiving antiplatelet and/or anticoagulant treatment (AP/AC) during EUS-guided biliary drainage (BD) procedures. The aim of this study was to assess whether hemorrhagic adverse events associated with EUS-BD are increased in patients on AP/AC. METHODS: Patients receiving AP/AC who underwent EUS-BD were retrospectively enrolled between May 2015 and August 2019. Patients who did not receive AP/AC and underwent EUS-BD in the same period were also enrolled as a control group. RESULTS: One hundred ninety-five patients who underwent EUS-BD were enrolled in this study. Among these, 154 patients were allocated to the control group and 41 patients to the AP/AC group. Overall frequency of adverse events did not differ significantly between the control group (16.2%, 25/154) and AC/AP group (17.1%, 6/41; P = .80). The overall bleeding event rate was 3.6% (7/195), with no significant difference between the 2 groups. No thromboembolic events were observed with or without interruption of AP/AC. According to logistic regression analysis, the use of AP/AC was not a risk factor significantly associated with bleeding events (odds ratio, 2.96; 95% confidence interval, .56-14.0; P = .18). On the other hand, a long procedure time (>20 minutes) was an independent risk factor associated with bleeding events. CONCLUSIONS: Bleeding events appear to be infrequent among patients who undergo EUS-BD while continuing AP/AC.

The New potential for Using Franseen Needles in Interventional EUS.

Objective Adverse events such as bile leakage and bleeding are among the issues that need to be resolved in EUS-guided choledochoduodenostomy (EUS-CDS). To overcome this problem, we developed a new EUS-CDS technique using a 19-G Franseen needle without tract dilation. This study aimed to evaluate the safety and efficacy of the new EUS-CDS technique. Methods This single-center retrospective study included 20 consecutive patients who underwent EUS-CDS for primary drainage using a 19-G Franseen needle between March 2020 and May 2023. The primary endpoint was the technical success rate of EUS-CDS without tract dilation. Results The technical success rate of EUS-CDS was 20/20 (100%). None of the patients required any additional tract dilation, such as by using a balloon or electric cautery. The median procedure time was 7.8 (range, 3.2-19.4) min. No early adverse events were observed. Conclusion The 19-G Franseen needle appeared to have a sufficient dilatory effect during puncturing. This EUS-CDS technique appears to be safe and effective and has the advantages of no adverse events and it is also a simplified procedure, which suggests its potential for widespread use in primary drainage.

Safety and efficacy of endoscopic ultrasound-guided pancreatic duct drainage using a drill dilator: a retrospective study from Japan.

Background/Aims: Dilation of the tract before stent deployment is a challenging step in endoscopic ultrasound-guided pancreatic duct drainage (EUS-PDD). In this study, we examined the effectiveness and safety of a novel spiral dilator, Tornus ES (Asahi Intec), for EUS-PDD. Methods: This was a retrospective, single-arm, observational study at Aichi Cancer Center Hospital. The punctured tract was dilated using a Tornus ES dilator in all EUS-PDD cases. Our primary endpoint was the technical success rate of initial tract dilation. Technical success was defined as successful fistula dilation using Tornus ES followed by successful stent insertion. Secondary endpoints were procedure times and early adverse events. Results: A total of 12 patients were included between December 2021 and March 2023. EUS-PDD was performed in 11 patients for post-pancreaticoduodenectomy anastomotic strictures and one patient with pancreatitis with duodenal perforation. The technical success rates of stent insertion and fistula dilation using Tornus ES dilator was 100%. The median procedure time was 24 minutes. No remarkable adverse events related to the procedure were observed, apart from fever, which occurred in 2 patients. Conclusions: Tract dilation in EUS-PDD using Tornus ES is effective and safe.

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.

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 bilateral revision after metal stent deployment for hepatic hilar obstruction using molting technique (with videos).

Background: After multiple uncovered self-expandable metal stent (UCSEMS) deployments, endoscopic revision becomes complex and potentially challenging. A novel stent delivery system with a dilation function has recently been developed in Japan. This study evaluated the technical feasibility of this device for patients with unresectable malignant hilar biliary obstruction (MHO) after multiple UCSEMS deployments. Method: Participants comprised consecutive patients with unresectable MHO who had undergone multiple UCSEMS deployments and required endoscopic revision for the right or left hepatic bile ducts, as decided by cholangiography under endoscopic retrograde cholangiopancreatography (ERCP) guidance. Results: A total of 14 patients requiring endoscopic revision of right and left hepatic bile ducts were enrolled in this study. Among these 14 patients, guidewire insertion through the mesh of previously placed stents failed in 2 patients. As a result, these two patients underwent only unilateral UCSEMS deployment. Because clinical success was not obtained, transmural placement of the UCSEMS under Endoscopic Ultrasound (EUS) guidance to the segment of the liver not being drained was performed in those patients. The molting technique was attempted in 12 patients, proving successful in all patients. The technical success rate was therefore 92.8% (12/14). Mean procedure time was 23.2 min. Conclusion: This novel stent delivery system with a dilation function may be useful in endoscopic revision techniques for bilateral UCSEMS deployment.

Partially covered self-expandable metal stent with antimigratory single flange plays important role during EUS-guided hepaticogastrostomy.

Background and study aims Stent migration into the abdominal cavity, which can occur due to stent shortening or stomach mobility, is a critical adverse event (AE) in EUS-HGS. To prevent this AE due to stent shortening, a novel, partially covered self-expandable metal stent with an antimigratory single flange has recently become available in Japan. The present study evaluated the clinical feasibility and safety of EUS-HGS using this novel stent. Patients and methods We measured stent length in the abdominal cavity and the luminal portion after EUS-HGS using computed tomography (CT) performed 1 day after EUS-HGS (early phase). To evaluate stent shortening and the influence of stomach mobility, we also measured stent length at the same sites on CT performed at least 7 days after EUS-HGS (late phase). Results Thirty-one patients successfully underwent EUS-HGS using this stent. According to CT in the early phase, stent length in the abdominal cavity was 7.13 ±â€Š2.11 mm and the length of the luminal portion was 53.3 ±â€Š6.27 mm. Conversely, according to CT in the late phase, stent length in the abdominal cavity was 8.55 ±â€Š2.36 mm and the length of the luminal portion was 50.0 ±â€Š8.36 mm. Stent shortening in the luminal portion was significantly greater in the late phase than in the early phase ( P  = 0.04). Conclusions CT showed that stent migration can occur even with successful stent deployment, due to various factors such as stent shortening. The antimigratory single flange may be helpful to prevent stent migration, but further prospective comparative studies are needed to confirm our results.

Can Lemborexant for Insomnia Prevent Delirium in High-Risk Patients with Pancreato-Biliary Disease after Endoscopic Procedures under Deep Sedation?

Background and aim: Pancreato-biliary patients who undergo endoscopic procedures have high potential risk of delirium. Although benzodiazepine has traditionally been used to treat insomnia, this drug might increase delirium. Lemborexant may be useful for patients with insomnia, without worsening delirium, although there is no evidence for high-risk patients with pancreato-biliary disease. The aim of this pilot study was to evaluate the safety and efficacy of lemborexant for insomnia and the frequency of delirium after endoscopic procedures under deep sedation in patients with pancreato-biliary disease. Method: This retrospective study included consecutive patients who were administered lemborexant after endoscopic procedures for pancreato-biliary disease between September 2020 and June 2022. The primary outcome of this study was evaluation of the safety and efficacy of lemborexant for insomnia. Frequency of delirium was the secondary outcome. Result: In total, 64 patients who had the complication of insomnia after an endoscopic procedure were included in the study. Risk factors for delirium were advanced age (n = 36, 56.3%), dementia (n = 10, 15.6%), and regular alcohol use (n = 13, 20.3%), as well as the sedatives midazolam and pentazocine that were administered to all patients at the time of the endoscopic procedure. Successful asleep was achieved by 61/64 patients (95.3%). No fall event was observed during the night following the procedure in any patient. However, mild consciousness transformation was observed in one patient. Conclusions: In conclusion, lemborexant use may be effective and safe for use after endoscopic procedures in pancreato-biliary patients, without increasing the risk of delirium.

Comparison of Endoscopic Hemostasis for Endoscopic Sphincterotomy Bleeding between a Novel Self-Assembling Peptide and Conventional Technique.

Introduction: Recently, a novel self-assembling peptide hemostatic gel has become available in Japan. However, the safety and efficacy of this novel self-assembling peptide hemostatic gel remain unclear for bleeding after EST. The aim of this study was to evaluate the safety and efficacy of a novel self-assembling peptide hemostatic gel for bleeding after EST, and to perform a comparison to a conventional endoscopic hemostasis technique. Method: This retrospective study was carried out between January 2019 and October 2022. Patients who developed bleeding associated with EST were enrolled. The patients were divided into two groups based on the hemostasis technique used: a conventional hemostasis technique (Group A) or a novel self-assembling peptide hemostatic gel hemostasis technique (Group B). Result: A total of 62 patients (Group A, n = 36; Group B, n = 26) were included. Endoscopic hemostasis was initially obtained in 72.2% (26/32) of patients in Group A and in 88.4% (23/26) of patients in Group B, which was not significantly different (p = 0.1320). However, the procedure time was significantly shorter in Group B (mean, 9.38 min) compared with Group A (mean, 15.4 min) (p = 0.0103). There were no significant differences in the severity of bleeding between the two groups (p = 0.4530). Post-EST bleeding was observed in six patients (Group A, n = 4; Group B, n = 2). Adverse events were more frequently observed in Group A (n = 12) than in Group B (n = 1) (p = 0.0457). Conclusions: PuraStat application for EST bleeding might be safe and effective, and is comparable to the conventional endoscopic hemostasis technique, although further prospective randomized trials are needed.

Endoscopic gallbladder drainage for acute cholecystitis with high-risk surgical patients between transduodenal and transpapillary stenting.

BACKGROUND AND OBJECTIVES: EUS-guided gallbladder drainage (GBD) has emerged as an alternative GBD technique, particularly for high-risk surgical patients. To prevent stent migration or to facilitate stent deployment, the lumen-apposing metal stent (LAMS) was recently developed for EUS-GBD. However, LAMS remains unavailable in several countries and is expensive compared with conventional fully covered self-expandable metal stent (FCSEMS). Although several studies have shown the clinical benefits of EUS-GBD using novel FCSEMS or LAMS compared with endoscopic transpapillary GBD (ETGBD), the choice between ETGBD and EUS-GBD using conventional FCSEMS and ETGBD remains controversial. The aim of this study was to evaluate EUS-GBD using conventional FCSEMS compared with ETGBD. Materials and Methods: This comparative retrospective study included consecutive symptomatic AC patients who underwent gallbladder drainage by either EUS-GBD or ETGBD between January 2015 and December 2018.The main outcome measures were technical success, clinical success, procedure-related and stent-related adverse events, and recurrence of AC during follow-up. RESULTS: Fifty-four patients (44.4% female, 55.6% male) who underwent EUS-GBD (n = 25) or ETGBD (n = 29) were enrolled. Initial technical success rates were 100% with EUS-GBD and 82.7% (24/29) with ETGBD. The median procedure time was significantly shorter for the EUS-GBD group than for the ETGBD group (11.0 vs. 24.0 min, P < 0.05). Procedure-related adverse events did not differ significantly between groups (P = 0.283). During follow-up (median 522 days, range 43 - 1892 days), recurrent acute cholecystitis (AC) was only observed in 4 patients from the ETGBD group. Overall survival did not differ significantly between the EUS-GBD group (mean 1070 days) and ETGBD group (mean 1470 days) (P = 0.292). CONCLUSION: The technical success rate for EUS-GBD using FCSEMS with plastic stent insertion was significantly higher with a shorter procedure time and resulted in a lower rate of recurrent AC.

Technical feasibility and safety of one-step deployment of EUS-guided hepaticogastrostomy using an 8-mm diameter metal stent with a fine-gauge stent delivery system (with video).

BACKGROUND AND OBJECTIVES: Adverse events (AEs) such as bile peritonitis or pneumoperitoneum might occur during procedural steps for EUS-guided hepaticogastrostomy (HGS), such as during device exchange and after fistula dilation until stent deployment. Reducing the steps to the EUS-HGS procedure might therefore be ideal to prevent the occurrence of AEs. Recently, a novel, fully covered self-expandable metal stent (FCSEMS) has become available. Because of the fine-gauge stent delivery system (5.9Fr), fistula dilation might not be needed before stent deployment during EUS-HGS. The aim of this pilot study was to evaluate the technical feasibility and safety of one-step EUS-HGS using a novel 8-mm diameter FCSEMS. PATIENTS AND METHODS: The primary outcome in this study was technical success, and the secondary outcomes were procedure- and stent-related AEs and clinical success. The technical success of one-step EUS-HGS was defined as successful FCSEMS deployment without any fistula dilation. Procedure time was measured from scope insertion to successful FCSEMS deployment. RESULTS: One-step EUS-HGS using the novel FCSEMS was attempted on 14 patients. Technical success with a short procedure time (median: 7 min) and clinical success were obtained in all patients. In addition, procedure-related AEs such as bleeding, bile peritonitis, and stent migration during the procedure were not observed in any patients. CONCLUSIONS: One-step EUS-HGS using the novel FCSEMS with a fine-gauge stent delivery system is technically feasible and shortens the procedure time with no requirement for additional fistula dilation, resulting in a potential reduction in procedure-related AEs.