A comparison of novel electrocautery-enhanced lumen-apposing metal stents and plastic stents in EUS-guided drainage of infected walled-off necrosis: A multicenter randomized study.

BACKGROUND AND STUDY AIMS: Although lumen-apposing metal stents (LAMSs) have been increasingly used for walled-off necrosis (WON), their advantages over plastic stents (PS) in infected WON are unclear. We investigated the safety and efficacy of novel electrocautery-enhanced LAMS (EC-LAMS) for managing infected WON. PATIENTS AND METHODS: Patients who underwent endoscopic ultrasound-guided WON drainage were randomly assigned to the LAMS or PS groups. The primary outcome was the total number of direct endoscopic necrosectomy (DEN) procedures required to achieve clinical success. The secondary outcomes included technical success, clinical success, and adverse event occurrence. RESULTS: Forty-six patients were divided into the LAMS or PS groups (n=23 each). The total number of DEN procedures did not differ significantly between the PS (four procedures, interquartile range [IQR] 2.5-5.0) and LAMS groups (nine procedures, IQR: 8.0-9.0) (P=0.07). The LAMS group demonstrated a significantly higher clinical success rate than the PS group based on intention-to-treat analysis (100% vs. 73.9%, P=0.03) at 8 weeks but not at 4 weeks. No significant bleeding events were reported in the LAMS group, and one was reported in the PS group. CONCLUSIONS: We found no significant difference in the total number of DEN procedures between LAMS and PS for managing infected WON. The only statistically significant finding was a higher clinical success rate at 8 weeks for patients treated with EC-LAMS. The use of EC-LAMS did not result in any adverse events, such as bleeding or buried LAMS syndrome, within the study duration.

Comparison of disposable digital single-operator cholangioscopy versus direct peroral cholangioscopy for the diagnosis of intraductal superficial lesions of the bile duct.

BACKGROUND: Disposable digital single-operator cholangioscopy (D-SOC) and direct peroral cholangioscopy (D-POC) using an ultraslim endoscope are established POC modalities for the diagnosis and treatment of various biliary diseases. We compared the usefulness of D-SOC and D-POC for the diagnosis of intraductal superficial lesions of the bile duct (ISL-Bs). METHODS: 38 consecutive patients with suspected biliary diseases who underwent both D-SOC and D-POC were enrolled. The primary outcome was ISL-B detection rate, and the secondary outcomes were technical success of POC and POC-guided forceps biopsy sampling (POC-FB), procedure time, visualization quality, and tissue adequacy. RESULTS: D-SOC had a higher technical success rate than D-POC but the difference was not statistically significant (100% vs. 92.1%, P = 0.25). D-POC had a marginally higher ISL-B detection rate (34.2% vs. 28.9%, P = 0.68) and significantly higher visualization quality (P = 0.03). The mean (SD) procedure time was significantly shorter with D-SOC (11.00 [1.33] vs. 19.03 [2.95] minutes, P<0.001). The technical success rate of POC-FB and tissue adequacy did not differ between the two techniques (D-SOC vs. D-POC: 81.8% vs. 84.6%, P = 0.69 and 77.8% vs. 90.9%, P = 0.57, respectively). CONCLUSIONS: Both POC systems were safe and useful for the detection, characterization, and diagnosis of minute ISL-Bs. While D-SOC displayed a shorter procedure time and a tendency for higher technical success rate, D-POC provided superior visualization quality, allowing detailed observation of the surface structure and microvascular patterns.

Detection and endoscopic classification of intraductal neoplasms of the bile duct by peroral cholangioscopy with narrow-band imaging (with videos).

BACKGROUND AND AIMS: Indirect diagnostic modalities are unsatisfactory for detecting intraductal neoplasm of the bile duct (IN-B), which can be detected by peroral cholangioscopy (POC) with narrow-band imaging (NBI). We investigated the POC findings of IN-B and developed a feasible endoscopic classification system. METHODS: Four hundred seventy-one patients who underwent direct POC from April 2008 to July 2020 were enrolled. Intraductal superficial lesions of the bile duct (ISL-Bs) were classified according to surface structure and microvascular pattern on POC with NBI and correlated to histologic findings after POC-guided forceps biopsy sampling (POC-FB) or surgery. The primary outcome was the detection rate of IN-Bs, and the secondary outcomes were the associations of POC findings with IN-B, technical success rates of POC and POC-FB, and adverse events. RESULTS: Direct POC was successful in 458 of 471 patients (97.2%). Among the patients, 131 (27.8%) exhibited ISL-Bs. The technical success rate of POC-FB was 94.7% (124/131). Among the 124 patients who underwent POC-FB, IN-B was revealed in 54 (43.5%), for a detection rate of 11.8% (54/458). Papillary lesions (P = .041), nodular lesions (P = .044), and irregularly or regularly dilated and tortuous vessels (P = .004 and P = .006, respectively) were POC findings associated with IN-B. The area under the receiver-operating characteristic curve of the novel classification system was .899. CONCLUSIONS: POC with NBI can be useful for the detection of IN-Bs. Our novel classification system based on both surface structure and microvascular pattern may allow differentiation of IN-B from ISL-Bs.

Preliminary feasibility study of a new partially covered self-expandable metal stent with an anchoring flange for EUS-guided hepaticogastrostomy (with videos).

BACKGROUND AND AIMS: EUS-guided hepaticogastrostomy (EUS-HPG) has a risk of serious procedural adverse events (AEs), but few dedicated devices for EUS-HPG are available. We evaluated the feasibility of a new partially covered self-expandable metal stent (PCSEMS) with an anchoring flange for EUS-HPG. METHODS: The feasibility of a stent featuring a proximal radiopaque uncovered portion 1.5 cm in length and a distal anchoring flange 20 mm in diameter was evaluated in consecutive patients undergoing EUS-HPG for unresectable malignant biliary obstruction. Primary outcomes were the technical and clinical success of EUS-HPG, and secondary outcomes were AEs, recurrent biliary obstruction (RBO), reintervention for RBO, and the technical feasibility of peroral cholangioscopy (POC) through the stent in situ. RESULTS: EUS-HPG was performed in 24 patients with unresectable malignant biliary obstruction. The technical and clinical success rates of EUS-HPG were 100% (24/24) and 91.7% (22/24), respectively. AEs developed after EUS-HPG in 8.3% of patients (2/24, cholangitis). RBO developed in 29.2% of patients (7/24), with a median cumulative time to RBO of 6.7 months. The causes of RBO were sludge formation (n = 4), hyperplasia at an uncovered portion (n = 2), and nonocclusive cholangitis (n = 1). Reintervention for RBO had a 100% success rate (7/7), and POC through the stent in situ was technically feasible in 7 of 8 patients with a stent diameter of 10 mm. CONCLUSIONS: EUS-HPG with a new PCSEMS can alleviate malignant biliary obstruction after failed ERCP. The novel stent evaluated in this study may prevent stent-related AEs, including stent migration, and allow advanced endoscopic interventions through the HPG route.

Comparison of the long-term outcomes between proximal and distal IgG4-related sclerosing cholangitis: A multicenter cohort study.

BACKGROUND AND AIMS: Immunoglobulin G4-related sclerosing cholangitis (IgG4-SC) is considered a biliary manifestation of IgG4-related diseases. However, there has been a controversy on the clinical outcomes according to the location of the involved bile duct. We therefore compared the clinical outcomes and long-term prognosis of IgG4-SC with proximal bile duct involvement (proximal IgG4-SC) and IgG4-SC with distal bile duct involvement (distal IgG4-SC). METHODS: We reviewed the data of patients with IgG4-SC that were prospectively collected at 10 tertiary centers between March 2002 and October 2020. Clinical manifestations, outcomes, association with autoimmune pancreatitis (AIP), steroid-responsiveness, and relapse of IgG4-SC were evaluated. RESULTS: A total of 148 patients (proximal IgG4-SC, n = 59; distal IgG4-SC, n = 89) were analyzed. The median age was 65 years (IQR, 56.25-71), and 86% were male. The two groups were similar in terms of jaundice at initial presentation (51% vs 65%; P = 0.082) and presence of elevated serum IgG4 (66% vs 70%; P = 0.649). The two groups showed significant differences in terms of steroid-responsiveness (91% vs 100%; P = 0.008), association with AIP (75% vs 99%; P = 0.001), and occurrence of liver cirrhosis (9% vs 1%; P = 0.034). During a median follow-up of 64 months (IQR, 21.9-84.7), the cumulative relapse-free survival was significantly different between the two groups (67% vs 79% at 5 years; P = 0.035). CONCLUSIONS: Relapse of IgG4-SC frequently occurred during follow-up. Proximal IgG4-SC and distal IgG4-SC had different long-term outcomes in terms of steroid-responsiveness, occurrence of liver cirrhosis, and recurrence. It may be advantageous to determine the therapeutic and follow-up strategies according to the location of bile duct involvement.

Feasibility of Cholangioscopy Using Multibending Ultra-Slim Endoscope Through a Lumen-Apposing Metal Stent for Choledochoduodenostomy.

BACKGROUND AND AIMS: Endoscopic ultrasound (EUS) guided choledochoduodenostomy using a lumen-apposing metal stent (LAMS) allows access to the biliary system with a sufficiently large diameter stent. However, an appropriate endoscope for this purpose is required. We evaluated the feasibility of per-oral cholangioscopy (POC) using a multibending ultra-slim endoscope through a LAMS for EUS-guided choledochoduodenostomy. METHODS: Twelve patients who underwent EUS-guided choledochoduodenostomy, followed by POC via a LAMS, were enrolled. POC was performed with an multibending ultra-slim endoscope. The primary outcome was technical success, defined as examination of both hepatic ducts and either the distal common bile duct or stricture site within 10 min. The types of intervention and adverse events were also assessed. RESULTS: Technical success was achieved in all cases with the multibending ultra-slim endoscope. Narrow-band imaging endoscopy was performed in five cases (41.7%) and POC-guided targeted biopsy was performed in three cases (25.0%). Stone extraction during POC was performed in two patients (16.7%) and foreign body removal from the intrahepatic duct was performed in one patient. One patient underwent additional metal stent insertion under direct visualization. After POC, no stent migration or severe adverse events were seen in any case. CONCLUSIONS: POC using a multibending ultra-slim endoscope for diagnostic or therapeutic purposes can be performed effectively and safely through a LAMS after EUS-guided choledochoduodenostomy.

Efficacy of narrow-band imaging during peroral cholangioscopy for predicting malignancy of indeterminate biliary strictures (with videos).

BACKGROUND AND AIMS: Direct peroral cholangioscopy (POC) can be useful when combined with narrow-band imaging (NBI) to explore the etiologies of indeterminate biliary strictures. We evaluated the efficacy of NBI compared with that of conventional white-light imaging (WLI) during POC diagnosis of indeterminate biliary strictures. METHODS: Consecutive patients with indeterminate biliary strictures were enrolled from 2016 to 2019. The primary outcome was diagnostic accuracy, and secondary outcomes were technical success, adverse events, and visualization quality when predicting malignancy. RESULTS: Seventy-one patients underwent direct POC under NBI during targeted biopsy sampling. The strictures were successfully explored and adequate biopsy samples obtained in 67 of 71 patients (94.4%). In terms of visual impression, WLI and NBI afforded 75.0% and 87.5% sensitivity, 82.9 and 91.4% specificity, and 82.8 and 91.3% accuracy, respectively. The areas under the WLI and NBI receiver-operating characteristic curves were .80 and .96 (P = .01). Under NBI, the visualization quality of surface structures, microvessels, and lesional margins was higher than that under conventional WLI (P < .05). CONCLUSIONS: Direct POC under NBI effectively and accurately predicts malignancies of indeterminate biliary strictures. NBI effectively illuminated surface structures, microvessels, and lesional margins.

Safety and efficacy of a novel electrocautery-enhanced lumen-apposing metal stent in interventional EUS procedures (with video).

BACKGROUND AND AIMS: Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures. METHODS: We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021. RESULTS: Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS. CONCLUSIONS: Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.

Peroral cholecystoscopy using a multibending ultraslim endoscope through a lumen-apposing metal stent for endoscopic ultrasound-guided gallbladder drainage: a feasibility study.

BACKGROUND: Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) has rendered endoscopic gallbladder assessment through a stent possible, but an appropriate endoscope is required. We assessed the feasibility of peroral cholecystoscopy (POCC) using a multibending ultraslim endoscope passed through a LAMS after EUS-GBD. METHODS: 14 patients with a LAMS for EUS-GBD who consecutively underwent POCC were included. POCC was performed using a multibending endoscope inserted through the LAMS. The primary outcome was the technical success rate, defined as complete endoscopic examination of the gallbladder from the orifice of the cystic duct to the fundus. The types of intervention and adverse events were recorded. RESULTS: 17 POCCs were performed in 14 patients. Of the 17 POCCs, 15 (88.2 %) were technically successful. Narrow-band imaging endoscopy was performed in 12 procedures (70.6 %), and cholecystoscopy-guided target biopsies were obtained in six. Gallstone extraction was performed in two patients. After POCC, all LAMSs remained stable and no adverse events were observed. CONCLUSIONS: POCC using a multibending ultraslim endoscope can be effectively and safely performed through a LAMS after EUS-GBD.

Modified non-flared fully covered self-expandable metal stent for preoperative biliary drainage in pancreatic cancer.

BACKGROUND AND AIM: Durable biliary drainage is essential in patients with pancreatic cancer in the era of effective neoadjuvant chemotherapy (NACT). Plastic stent (PS) tends to occlude easily, and current metal stents are designed for nonresectable cancer. We evaluated the efficacy of a modified non-flared fully covered self-expandable metal stent (M-FCSEMS) during the perioperative period in patients with resectable or borderline resectable pancreatic cancer. METHODS: Consecutive patients with resectable or borderline resectable pancreatic ductal adenocarcinoma had a 12-mm M-FCSEMS (M-FCSEMS group) or 7-Fr PS (PS group) placed for biliary decompression before NACT or curative-intent surgery. The primary outcome was the re-intervention rate, and secondary outcomes were technical success, stent patency, and adverse events (AEs). RESULTS: Endoscopic stent placement was technically successful in all 60 patients. Twenty-three patients underwent surgery and 37 NACT before surgery. Re-intervention was performed in 10.0% (3/30) of patients in the M-FCSEMS group and 36.7% (11/30) of patients in the PS group (P = 0.030). The stent patency at 180 days was 89.8% (95% confidence interval, 77.3-100.0%) in the M-FCSEMS group and 30.2% (95% confidence interval, 11.4-80.0%) in the PS group (P < 0.0001). Stent-related AEs occurred in 10.0% (3/30) in the M-FCSEMS group and 40.0% (12/30) in the PS group (P = 0.015). Surgery-related AEs occurred in 10.5% (2/19) and 14.3% (3/21) in the M-FCSEMS and PS groups (P = 0.549). CONCLUSIONS: Modified non-flared fully covered self-expandable metal stents are effective and safe for durable biliary drainage in patients with resectable or borderline resectable pancreatic cancer during the perioperative period.

Endoscopic Bilateral Stent-in-Stent Versus Stent-by-Stent Deployment in Advanced Malignant Hilar Obstruction: A Meta-Analysis and Systematic Review.

BACKGROUND AND AIM: There is no clear data to compare the effectiveness and safety of bilateral stent-in-stent (SIS) or stent-by-stent (SBS) deployment for advanced malignant hilar obstruction (MHO). This meta-analysis was done to investigate clinical outcomes of these deployment methods. METHODS: We did a literature search to identify studies that reported the clinical outcomes of bilateral metal stents in patients with advanced MHO. Weighed pooled rates (WPR) along with 95% confidence interval (95% CI) were calculated in order to compare outcomes including technical and clinical success, adverse events, and stent occlusion between the two groups. We conducted a meta-analysis using a random-effects model. RESULTS: Five comparative studies with 250 patients, and 20 single-arm studies for the SIS or SBS method were eligible for the meta-analysis and systematic review. The bilateral SIS deployment had a significantly higher technical success rate than did SBS deployment (OR 6.43; 95% CI 1.08-38.09). There was no difference in the clinical success (OR 1.23; 95% CI 0.45-3.38), overall adverse events rates (OR 0.42; 95% CI 0.15-1.18), or overall occlusion rate (OR 1.55; 95% CI 0.89-2.70). As a single-armed group, WPR of technical success of the SIS and SBS groups was 96.4% and 89.6%, respectively. Clinical success was 97.5% and 98.3%. Overall, adverse events were 35.9% and 22.6%. Occlusion rates were 27.7% and 37.7%. CONCLUSIONS: Although there was a lack of quality data and heterogeneity, bilateral SIS deployment had a higher technical feasibility than did the SBS method in patients with advanced MHO, without differences in terms of clinical success, adverse events, or occlusion rates.

A Preliminary Study on the Efficacy of Single-Operator Cholangioscopy with a New Basket for Residual Stone Retrieval After Mechanical Lithotripsy.

BACKGROUND AND AIM: The detection of residual or fragmented common bile duct (CBD) stones after lithotripsy can be improved by the high-resolution imaging quality of digital, single-operator cholangioscopy (SOC). However, therapeutic interventions for the removal of residual CBD stones are limited by the lack of appropriate tools. We retrospectively evaluated the role of SOC and the newly developed Dormia basket for the evaluation and removal of stones remaining after lithotripsy. METHODS: Thirty-four patients who had undergone lithotripsy for retained CBD stones with no evidence of filling defects in occluded balloon cholangiography from March 2017 to October 2018 were included in the study. After balloon cholangiography, the bile duct was evaluated by SOC for complete evacuation of the stones. The detected residual CBD stones were directly retrieved by inserting the newly developed Dormia basket into the working channel of the SOC. The incidence of residual stones detected by SOC and the success rate of residual stone retrieval by SOC were investigated. RESULTS: Digital SOC was successfully performed in all patients. Of these, 11 patients (32.4%) had residual CBD stones. The residual stones were successfully removed in 10 patients (90.9%) by SOC using the Dormia basket, except in one case of residual stones left in the hepatic duct. There were no adverse events associated with the SOC procedures or direct stone removal. CONCLUSIONS: Digital SOC combined with the newly developed Dormia basket was useful for the detection and extraction of residual CBD stones under direct visualization after lithotripsy.

Use of peroral cholangioscopy to screen for neoplastic bile duct lesions in patients with bile duct stones (with videos).

BACKGROUND AND AIMS: Although cholangiocarcinomas (CCAs) can be diagnosed using several modalities, the detection of early-stage cancers remains unsatisfactory. We explored whether peroral cholangioscopy (POC) could be used to screen for neoplastic bile duct lesions including CCAs in patients with bile duct stones. METHODS: Two hundred seven patients who underwent endoscopic removal of bile duct stones were enrolled between August 2010 and July 2018. The primary outcome was the detection rate of intraductal neoplastic biliary lesions by direct POC. Secondary outcomes were the technical success rates of direct POC and POC-guided forceps biopsy sampling (POC-FB), the diagnostic accuracy of the direct POC findings, adverse events, and the number needed to screen to detect a neoplastic bile duct lesion. RESULTS: Direct POC was successful in 199 of 207 patients (96.1%). Mild cholangitis developed in 2 patients (1.0%) and was treated conservatively. Of the 199 successfully performed POCs, 31 patients (15.6%) exhibited abnormal intraductal mucosal lesions. The technical success rate of POC-FB was 90.3% (28/31 patients). The pathologic diagnoses after POC-FB were CCAs (n = 4), intraductal papillary neoplasms of the bile duct (IPN-B) (n = 2), an adenoma with dysplasia (n = 1), and benign lesions (n = 21). Direct POC correctly distinguished non-neoplastic from neoplastic bile duct lesions in 91.6% of patients. Curative surgical resection was performed for the 5 patients with CCAs or IPN-B. The number needed to screen to detect a neoplastic bile duct lesion was 29.6. CONCLUSIONS: Direct POC using a dedicated, ultraslim upper endoscope usefully screens for neoplastic bile duct lesions including CCAs in selected patients with bile duct stones.

A novel electrocautery-enhanced delivery system for one-step endoscopic ultrasound-guided drainage of the gallbladder and bile duct using a lumen-apposing metal stent: a feasibility study.

BACKGROUND: The use of a lumen-apposing metal stent (LAMS) capable of one-step endoscopic ultrasound-guided transmural drainage (EUS-TD) can increase the effectiveness of the procedure. We evaluated the newly developed electrocautery-enhanced (EC) delivery system with a LAMS for one-step EUS-guided gallbladder drainage (EUS-GBD) or choledochoduodenostomy (EUS-CDS). METHODS: In the animal experiment, an EC-LAMS was advanced into the gallbladder without prior tract dilation in four pigs. A conventional LAMS was inserted in another four pigs as a control group. After the animal experiment, 17 patients underwent EUS-TD using the EC-LAMS (EUS-GBD in 10 patients, EUS-CDS in 7). The primary outcome was the technical success rate. RESULTS: In the animal study, the mean procedure time was significantly shorter in the EC-LAMS group than in the conventional LAMS group. In the human study, the overall technical success rate was 94.1 %, with one EUS-GBD failure. The clinical success rate was 100 %. The overall adverse event rate was 17.6 %. CONCLUSIONS: One-step EUS-GBD or EUS-CDS using the novel EC-LAMS is a feasible approach that achieves a high success rate and maintains safety.

Efficacy of a modified short fully covered self-expandable metal stent for perihilar benign biliary strictures.

BACKGROUND AND AIM: Endoscopic management of a benign biliary stricture (BBS) on the hilum is complicated and challenging. Although the placement of a fully covered self-expandable metal stent (FCSEMS) is possible to increase effectiveness, stent migration and stent-induced adverse events are problematic. We aimed to evaluate the usefulness of a modified short FCSEMS with a long lasso in patients with a difficult perihilar BBS. METHODS: Patients with perihilar BBS within 2 cm from the hilar confluence that failed initially with plastic stents were enrolled. A modified short FCSEMS was deployed and then removed 5-6 months later. The primary outcome was clinical success. Other technical success, adverse events, endoscopic success of stent removal, and recurrence of stricture during the follow-up period were measured. RESULTS: Endoscopic intraductal placement was technically successful in all patients (n = 19). Combined contralateral plastic stent placement was performed in 13 patients (68.4%). The median duration of stent placement was 163 days (range, 138-196 days). Endoscopic stent removal was successful in all patients except one spontaneous distal migration. Stricture resolution without de novo focal stricture occurrence was 100%. Endoscopic stone removal after stricture improvement was successful in all 13 patients with bile duct stones above the stricture. During a follow-up period (median 635 days) after stent removal, only one recurrence developed. CONCLUSIONS: Temporary placement of a modified intraductal short FCSEMS with or without a contralateral plastic stent improved perihilar BBS in patients that primarily failed by plastic stents. Combined biliary stones were also successfully removed after stricture resolution.

Can prophylactic argon plasma coagulation reduce delayed post-papillectomy bleeding? A prospective multicenter trial.

BACKGROUND AND AIM: Endoscopic post-papillectomy bleeding occurs in 3% to 20% of the cases, and delayed bleeding is also problematic. However, there is no consensus on how to reduce delayed post-papillectomy bleeding. The aim of this study was to evaluate the efficacy of prophylactic argon plasma coagulation (APC) to minimize delayed bleeding and reduce the persistence of residual tumors after endoscopic papillectomy. METHODS: In a prospective pilot study of patients with benign ampullary tumors, the prophylactic APC group underwent APC at the resection margin following a conventional snaring papillectomy. Then, 24 h later after the papillectomy, all patients underwent a follow-up duodenoscopy to identify post-papillectomy bleeding and were followed up until 12 months. The main outcomes were the delayed (≥24 h) post-papillectomy bleeding rate and the tumor persistence rate. RESULTS: The delayed post-papillectomy bleeding rate was 30.8% (8/26) in the prophylactic APC group and 21.4% (6/28) in the non-APC group (P = 0.434). The post-procedure pancreatitis rates were 23.1% (6/26) and 35.7% (10/28), respectively (P = 0.310). The rate of tumor persistence did not differ between the two groups at 1 month (12.5% vs 7.4%, P = 0.656), 3 months (4.2% vs 3.7%, P = 1.00), 6 months (8.3% vs 3.7%, P = 0.595), and 12 months (0% vs 3.7%, P = 1.00). There were no procedure-related mortalities or serious complications. CONCLUSION: Prophylactic APC may not be effective in reducing delayed post-papillectomy bleeding or remnant tumor ablation immediately after conventional papillectomy (Clinical trial registration-cris.nih.go.kr; KCT0001955).

Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial.

BACKGROUND: Long-term placement of lumen apposing metal stents (LAMS) with high lumen apposing force may result in adverse events. The aim of the current study was to assess the long-term efficacy and safety of a self-approximating LAMS with lower lumen apposing force for endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) and -gallbladder drainage (EUS-GBD). METHODS: Five Asian institutions participated in this study. Consecutive patients suffering from obstructive jaundice with failed ERCP or acute cholecystitis that were at high risk for cholecystectomy were recruited. We evaluated the technical and clinical success rates, adverse events rates, types of interventions through the stent and the patency profile. RESULTS: From June 2017 to Oct 2018, a total of 53 patients received EUS-CDS (26) and EUS-GBD (27). The technical and clinical success rates were similar between the two groups (88.5% vs 88.9%, P = 1 and 88.5% vs 88.9%, P = 1 respectively). The differences in 30-day mortality rates [2 (7.7%) vs 2 (7.7%), P = 1] and adverse events [3 (11.5%) vs 3 (11.5%), P = 1] did not reach significance. Regarding long-term outcomes, two patients in each group suffered from adverse events (P = 1). One patient in the EUS-GBD group who was on direct oral anticoagulant suffered from stent induced bleeding. CONCLUSION: The self-approximating LAMS with lower lumen apposing force was effective and safe with a low risk of buried stent syndrome and bleeding in the longer term. The ClinicalTrials.gov Identifier was NCT03002051.

Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video).

BACKGROUND AND AIMS: Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. In this study, we evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories. METHODS: Ninety-two patients with biliary disease requiring diagnostic and/or therapeutic direct POC were assigned randomly to groups examined using an MB ultra-slim endoscope (MB group, n=46) versus a conventional ultra-slim endoscope (conventional group, n=46). The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 minutes. RESULTS: Free-hand biliary insertion of the endoscope for direct POC was technically successful in 41 patients (89.1%) in the MB group, which was significantly higher than the rate (14 patients, 30.4%) in the conventional group (P < .001). The procedure time (mean ± standard deviation) of direct POC using free-hand biliary insertion of the endoscope was significantly shorter in the MB group than in the conventional group (3.2 ± 1.8 vs 6.0 ± 3.0 minutes, P = .004). Adverse events were observed in 3 patients (6.5%) in the MB group and 2 patients (4.3%) in the conventional group (P = .500), all of whom were treated conservatively. The technical success rates of the diagnostic or therapeutic intervention were not significantly different between the 2 groups in patients undergoing successful direct POC. CONCLUSIONS: Free-hand biliary insertion of the MB ultra-slim endoscope showed a high technical success rate without severe adverse events and effectively decreased procedure time compared with a conventional ultra-slim endoscope. Direct POC using the MB ultra-slim endoscope can be used for novel diagnostic and therapeutic procedures of the biliary tree without the assistance of another endoscope or accessory. (Clinical trial registration number: NCT02189421.).

Comparison of the effectiveness and safety of lumen-apposing metal stents and anti-migrating tubular self-expandable metal stents for EUS-guided gallbladder drainage in high surgical risk patients with acute cholecystitis.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using an anti-migrating tubular self-expandable metal stent (ATSEMS) is performed in high surgical risk patients with acute cholecystitis. The newly introduced lumen-apposing metal stent (LAMS) is expected to reduce the risk of tubular self-expandable metal stent-related adverse events such as stent migration, but no comparative studies have been carried out between LAMSs and ATSEMSs for EUS-GBD. METHODS: We reviewed the prospectively collected EUS-GBD database at Asan Medical Center and Bucheon Soonchunhyang hospital to analyze consecutive patients with acute cholecystitis who underwent EUS-GBD with LAMSs or ATSEMSs between January 2015 and December 2017. Technical success, clinical success, adverse events, and recurrence of cholecystitis were evaluated. RESULTS: A total of 71 patients (36 with LAMSs, 35 with ATSEMSs) were analyzed. The LAMS group had longer median procedure time (15.5 minutes) than the ATSEMS group (11 minutes; P = .017). The 2 groups did not show significant differences in terms of technical success (LAMS, 94% vs ATSEMS, 100%; P = .49), clinical success (94% vs 100%; P = .49), procedure-related adverse events (0% vs 2.9%; P = .99), and stent-related late adverse events (11.8% vs 5.8%; P = .43). During follow-up, the 2 groups had similar rates of cholecystitis recurrence at 6 months (LAMS, 3.4% vs ATSEMS, 3.1%, P = .99) and 12 months (8.3% vs 3.1%, P = .56). CONCLUSIONS: In high surgical risk patients with acute cholecystitis, LAMSs and ATSEMSs for EUS-GBD showed similar rates of technical success, clinical success, procedure-related adverse events, stent-related late adverse events, and recurrence of cholecystitis.

Preliminary study of a modified, nonflared, short, fully covered metal stent for refractory benign pancreatic duct strictures (with videos).

BACKGROUND AND AIMS: Fully covered self-expanding metal stents (FCSEMSs) are considered to be more effective than plastic stents for the treatment of main pancreatic duct (MPD) strictures associated with chronic pancreatitis (CP) because of their larger diameter and exertion of a radial expansion force. However, the current FCSEMSs have several limitations. To overcome these, a novel modified nonflared FCSEMS was developed. In this study we conducted a prospective long-term follow-up evaluation of the efficacy of the novel FCSEMS for the treatment of refractory benign PD strictures in patients with CP. METHODS: Consecutive patients with symptomatic CP associated with refractory MPD strictures were enrolled prospectively in this single-arm study. The nonflared FCSEMS was placed intraductally or transpapillary according to the location and length of the stricture. Stent removal was performed at 3 months after placement. The primary outcome was the resolution of the pancreatic ductal stricture. RESULTS: Endoscopic placement of modified nonflared FCSEMSs was technically successful in all 25 patients. Intraductal FCSEMS placement was performed in 14 patients (56.0%). Stents of diameter 8 mm were used in 17 patients (68.0%). Stents of lengths 3 and 5 cm were inserted in 22 (88.0%) and 3 (12.0%) patients, respectively. In 1 patient (4.0%), stent migration developed. All other stents were removed successfully. After stent removal, resolution of the MPD stricture was confirmed in all patients, and no FCSEMS-related de novo stricture was observed. During the follow-up period (median, 34 months; interquartile range, 25-56) after the stents had been removed from the 25 patients, reintervention for recurrence of MPD stricture with abdominal pain was performed in 2 patients (8.0%). CONCLUSIONS: Endoscopic placement of a novel modified nonflared FCSEMS resulted in long-term stricture resolution with pain relief and reduced the rate of stent-related adverse events, particularly stent migration and stent-induced de novo MPD stricture. (Clinical trial registration number: UMIN000035681.).