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Competing Interests: Disclosure This work was partly supported by the SoonChunHyang University Research Fund. All authors disclosed no financial relationships. Commentary Gallbladder adenocarcinoma is relatively uncommon, with <2 cases per 100,000 people in the United States. In the current case, the authors diagnosed this rare cancer in an elderly woman who experienced acute cholecystitis requiring EUS-guided gallbladder drainage by use of a LAMS. After introducing the upper endoscope through the LAMS, the authors were able to visualize frond-like masses and take a biopsy sample, examination of which later indicated gallbladder adenocarcinoma. They illustrate 2 relatively new enhanced imaging modes, which help in diagnosing early cancer. Texture and color enhancement imaging (TXI) combines 3 images into 1 image: 1 with dark areas brightened, 1 with color difference expansion, and 1 with enhanced texture sharpness. The “3-in-1” approach has been shown in randomized trials to increase the adenoma detection rate during colorectal cancer screening. Unique about TXI compared with NBI is that it preserves a somewhat normal appearance to the image while allowing enhanced lesion detection and characterization. Finally, although the authors showcase RDI in their last image, this technology is primarily designed to allow easier identification of bleeding points in a bloody field during endoscopic surgery rather than for diagnostic purposes. Fares Ayoub, MD, Assistant Professor of Medicine, Baylor College of Medicine, Houston, Texas, USA Mohamed O. Othman, MD, GIE Senior Associate Editor

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., Competing Interests: Disclosure The following author received research support for this study in part from the SoonChunHyang University Research Fund: J. H. Moon. In addition, the following author disclosed financial relationships: J. H. Moon: Inventor of the Niti-S Spaxus-MG stent. All other authors disclosed no financial relationships., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2020. Published by Elsevier Inc.)

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.)., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Recently, a newly designed lumen-apposing metal stent (LAMS) with a conventional delivery system was developed. The purpose of this study was to evaluate the effectiveness and safety of a newly designed LAMS for EUS-guided drainage to treat symptomatic pancreatic pseudocysts., Methods: This prospective multicenter cohort study included 34 patients with symptomatic pancreatic pseudocysts from 2016 to 2017. The patients underwent EUS-guided drainage with the newly designed LAMS (Niti-S SPAXUS; Taewoong Medical Co, Ltd, Ilsan, South Korea). Effectiveness outcome measurements included technical success rate, clinical success rate, successful stent removal rate, and procedural time. Safety outcome measurements included procedure and/or stent-related adverse events (AEs) and overall AEs. Patients were prospectively followed, and consecutive data were collected at discharge, at stent removal, and 20 days after stent removal., Results: Thirty-four patients (mean age 51.7 ± 13.3 years, 26 men) were enrolled. The mean pseudocyst size was 9.23 ± 3.54 cm. The technical success rate was 97.1% (33/34). The clinical success rate was 94.1% (32/34). All stents were successfully removed. The mean procedural time from needle puncture to stent deployment was 10.3 ± 5.7 minutes. Four patients (11.8%) experienced procedure and/or stent-related AEs, including stent maldeployment (n = 1) and pseudocyst infection (n = 3). All patients completely recovered from the AEs. Bleeding caused by the stent or buried LAMS syndrome was not observed. No unplanned endoscopic procedures were required., Conclusions: This study showed that EUS-guided drainage using the newly designed LAMS is technically feasible and effective for the treatment of symptomatic pancreatic pseudocysts. (Clinical trial registration number: NCT02730663.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Although the efficacy of palliative bilateral biliary drainage using self-expandable metal stents has been demonstrated, it is unclear which bilateral method is optimal for advanced malignant hilar biliary strictures (MHSs). This pilot study compared bilateral stent-in-stent (SIS) with stent-by-stent (SBS) deployment for advanced MHSs., Methods: Patients with inoperable high-grade MHSs were enrolled in this prospective randomized multicenter study. The primary outcome was the rate of adverse events, whereas secondary outcomes were technical and clinical success, reintervention, therapeutic outcomes, stent patency, and survival duration., Results: This study randomized 69 of 74 pathologically diagnosed patients to the SIS (n = 34) or SBS (n = 35) groups. The total adverse event rate after stent deployment did not differ between the 2 groups (23.5% in the SIS group vs 28.6% in the SBS group, P = .633). The primary technical success rate was 100% (34/34) and 91.4% (32/35) in the SIS and SBS groups, respectively (P = .081). The clinical success rate was 94.1% (32/34) and 90.6% (29/32), respectively (P = .668). The stent patency rate at 3 months was 85.3% in the SIS group and 65.7% in the SBS group (P = .059). At 6 months, the stent patency rate was 47.1% and 31.4%, respectively (P = .184). The median cumulative stent patency and survival probability did not differ between the 2 groups., Conclusions: Efficacy of bilateral SIS and SBS deployment may be similar in terms of total adverse events, technical and clinical success, stent patency, and survival. The stent patency rates at 3 and 6 months was higher in the SIS group without statistical difference. (Clinical trial registration number: NCT01141088.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: EUS-guided fine-needle aspiration/biopsy (EUS-FNA/B) has a high diagnostic accuracy for pancreatic tumors. Most reports have focused on the diagnostic yield of cytology or histology; the ability of various FNA/B techniques to obtain an adequate mass of cells or tissue has rarely been investigated., Methods: Patients with suspected pancreatic malignancy underwent EUS-FNB using a 22-gauge ProCore needle by either the stylet slow-pull-back technique (group A), conventional negative suction after stylet removal (group B), or non-suction after stylet removal (group C) in the absence of an on-site cytopathologist. The adequacy of the 3 techniques based on the diagnostic yield, cellularity, blood contamination, and core-tissue acquisition was evaluated., Results: A total of 50 patients (27 males) were analyzed. The mean tumor size was 21 to 40 mm in 54%. The rate of a good or excellent proportion of cellularity was highest in group A compared with groups B and C (72% vs 60% vs 50%, P = .049). A >25% rate of blood contamination was more prevalent in group B (30% vs 42% vs 10%, P = .009). The rate of adequate core-tissue acquisition was not different (52% vs 34% vs 50%, P = .140). Based on the multivariate generalized estimation equation, the stylet slow-pull-back technique and a tumor size >40 mm were favorable factors for diagnostic adequacy., Conclusions: The stylet slow-pull-back technique might enable acquisition of tissue and assessment of cellularity for the diagnosis of pancreatic tumors suspected to be malignant. (Clinical trial registration number: KCT0002190.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The efficacy of palliative biliary drainage by using bilateral or unilateral self-expandable metal stents (SEMSs) for a malignant hilar biliary stricture (MHS) remains controversial. This prospective, randomized, multicenter study investigated whether bilateral drainage by using SEMSs is superior to unilateral drainage in patients with inoperable MHSs., Methods: Patients with inoperable high-grade MHSs who underwent palliative endoscopic insertion of bilateral or unilateral SEMSs were enrolled. The main outcome measurements were the rate of primary reintervention for malfunction after successful placement of SEMSs, stent patency, technical and clinical success rates, adverse events, and survival duration., Results: A total of 133 pathology-diagnosed patients were randomized to the bilateral group (n = 67) or the unilateral group (n = 66). The primary technical success rates were 95.5% (64/67) and 100% (66/66) in the bilateral and unilateral groups, respectively (P = .244). The clinical success rates were 95.3% (61/64) and 84.9% (56/66), respectively (P = .047). The primary reintervention rates based on the per-protocol analysis were 42.6% (26/61) in the bilateral group and 60.3% (38/63) in the unilateral group (P = .049). The median cumulative stent patency duration was 252 days in the bilateral group and 139 days in the unilateral group. The risk of stent patency failure was significantly higher in the unilateral group (log-rank test; P < .01). In a multivariate Cox proportional hazard model to assess stent patency, bilateral SEMS placement was a favorable factor (adjusted hazard ratio 0.30, 95% confidence interval, 0.172-0.521; P < .001). Survival probability and late adverse events were not different between the 2 groups., Conclusions: Unilateral and bilateral drainage strategies by using SEMSs had similar technical success rates, but bilateral drainage resulted in fewer reinterventions and more durable stent patency in patients with inoperable high-grade MHSs. (Clinical trial registration number: NCT02166970.)., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Whether or not submucosal injection of a diluted epinephrine solution should be used to lift ampullary tumors during endoscopic snare papillectomy is unclear. This study aimed to investigate the clinical efficacy of a simple snaring method versus submucosal injection for papillectomy., Methods: A prospective multicenter study was performed at 4 tertiary referral centers. Patients with papillary lesions were randomized to undergo either simple snare papillectomy (SSP) or submucosal injection papillectomy (SIP) using 1:10,000 diluted epinephrine. The main outcome measures were complete resection rate and post-papillectomy adverse events., Results: A total of 50 patients with biopsy-proven papillary adenomas were enrolled. Complete resection rates in the SSP and SIP groups were 80.8% (21/26) and 50.0% (12/24), respectively (P = .02). However, tumor persistence at 1 month (15.4% vs 8.3%, P = .62) and recurrence at 12 months (12.0% vs 9.5%, P = .58) did not differ despite initial differences in the prevalence of a positive resection margin. The mean tumor size was 12 mm in the SSP group and 9.29 mm in the SIP group. Post-papillectomy bleeding developed in 42.3% (11/26) and 45.8% (11/24) of patients, respectively (P = .80). Delayed bleeding (>12 h) occurred in 27.3% (3/11) and 36.4% (4/11) of patients, respectively (P = .50). Post-procedure pancreatitis occurred in 15.4% (4/26) and 25% (6/24) of patients, respectively (P = .49). Pancreatitis severity did not differ between the groups, and there were no procedure-related mortalities., Conclusions: Although the recurrence rate was similar between the SSP and SIP groups, SIP showed no advantage over SSP in terms of achieving complete resection or decreasing the frequency of post-papillectomy adverse events, such as bleeding. SSP may thus be a simpler and primarily recommendable technique. (Clinical trial registration number: NCT02165852.)., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Several EUS-specific stents have become available. It has been claimed that some of these stents have lumen-apposing properties, but objective data measuring such properties are not available. The aim of this study is to measure the lumen-apposing force (LAF) of these stents., Methods: The LAF of 3 EUS-specific metallic stents (stents A, N, and S) were compared in an ex vivo setting. Four types of anastomoses were performed with the stents including cholecysto-duodenal, cholecysto-gastric, gastro-gastric, and gastro-jejunal and compared with a hand-sewn (HS) equivalent of the anastomosis. The outcome parameter was the LAF created by each type of stent., Results: Sixty-four anastomoses were created. The overall mean (standard deviation) LAFs were significantly higher for stents A and S (P < .001). This difference persisted regardless of the type of anastomosis: gastro-gastric (P = .002), gastro-jejunal (P = .005), cholecysto-gastric (P = .002), and cholecysto-jejunal (P = .003). The differences in LAF created by each type of stent across different types of anastomoses were also compared. A trend to significance was observed in the anastomoses created by stent N (P = .064) and stent A (P =.052); a significant difference in LAF was observed among different anastomoses created by stent S (P = .015). The LAF created by HS anastomosis was significantly higher than that for all stents across all anastomoses., Conclusions: Stents A and S had a higher LAF. The use of these stents should be considered when performing EUS-guided transmural luminal anastomoses in non-adherent organs. Further studies are required to confirm the clinical efficacies of these EUS-specific stents., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: In patients with unresectable distal malignant biliary obstruction (MBO), endoscopic biliary drainage by using self-expandable metal stents (SEMSs) is an established palliative treatment. However, the placement of a SEMS across the major duodenal papilla prompts reflux of duodenal contents. In this study, we evaluated stent patency and duodenobiliary reflux caused by a newly developed SEMS with an antireflux valve (ARV) of the windsock type, compared with a conventional covered SEMS (cSEMS) in patients with MBO., Methods: Between January 2013 and September 2014, 77 patients with unresectable distal MBO were assigned randomly to groups treated with an ARV metal stent (ARVMS) group (39 patients) or a conventional cSEMS group (38 patients). In all patients, a barium meal examination was performed to evaluate reflux of barium within the SEMS and intrahepatic bile ducts. The primary outcome was stent patency duration. Secondary outcomes were the rates of technical and clinical success, duodenobiliary reflux on barium meal examination, factors causing stent dysfunction, overall patient survival, and adverse events., Results: Stent placement was technically successful in all patients. The clinical success rates were not statistically significantly different between the ARVMS and cSEMS groups (97.4% vs 97.4%, P = 1.000). Overall reflux of barium was significantly lower in the ARVMS group than the cSEMS group (7.7% vs 100%, P < .001). The cumulative duration of stent patency was significantly longer in the ARVMS group than in the cSEMS group (median ± SD, 407 ± 92 vs 220 ± 37 days; P = .013). On multivariate analysis, complete duodenobiliary reflux (odds ratio, 5.7, P = .004) and ampullary cancer (odds ratio, 8.98, P = .012) were identified as independent risk factors for stent dysfunction. There was no significant difference between the 2 groups in overall patient survival or in the incidence of adverse events., Conclusions: The newly developed ARVMS seemed to have a superior duration of stent patency and comparable safety compared with the cSEMS. In addition, the duodenobiliary reflux related to stent dysfunction can be prevented effectively by ARVMS. Further randomized, controlled trials using large numbers of subjects are required to confirm the benefit of SEMSs with antireflux function. (Clinical trial registration number: UMIN000012734.)., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Direct peroral cholangioscopy (POC) by using an ultraslim upper endoscope has been increasingly applied for diagnosis and treatment of diverse biliary diseases. Recently, an intraductal balloon catheter has been used commonly to guide the flexible ultraslim endoscope. However, accessibility into the bile duct remains a limitation of the procedure. The aim of this study was to evaluate the feasibility and success rate of an intraductal balloon-guided direct POC by using an ultraslim endoscope with a newly modified 5F balloon catheter., Methods: In total, 36 patients with biliary obstruction were included prospectively for a direct POC by using an ultraslim endoscope with a newly modified intraductal 5F balloon catheter. The main outcome measure was technical success, defined as successful advancement of the ultraslim endoscope into the obstructed segment of the biliary tree or the bifurcation. Secondary outcomes were mean time for the total procedure, intubation into the common bile duct and advancement up to the target site after intubation of the ultraslim endoscope, technical success rates of diagnostic and therapeutic interventions, and adverse events., Results: The intraductal balloon-guided direct POC using a newly modified 5F balloon catheter was completed successfully in 35 of 36 patients (97.2%). The mean times for total procedure, intubation into the distal common bile duct, and advancement up to the obstructed bile duct segment were 27.3 ± 7.2, 2.2 ± 0.5, and 0.8 ± 0.4 minutes, respectively. In total, 49 interventions were performed in 35 patients, excluding 1 patient in whom we failed to perform direct POC. Technical success of the interventions was achieved with 44 of 49 procedures (89.8%). No adverse events, including cholangitis, were observed., Conclusions: A newly modified 5F balloon catheter seemed to facilitate performing intraductal balloon-guided direct POC for direct visual examination of the bile duct in patients with biliary obstruction. Continued development of endoscopes and accessories are expected to further improve the performance of direct POC., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: A reproducible large animal model of bile duct dilation for the preclinical testing of new biliary devices and for training endoscopic biliary intervention is required. Surgical methods are mainly used to produce large animal models of biliary obstruction., Objective: To develop an animal model of bile duct dilation using endoscopic methods and to compare the merits of endoclips and detachable snares for the obstruction of major duodenal papillae., Design: Proof of concept experimental study., Settings: Animal laboratory., Interventions: Endoscopic clipping of the major duodenal papilla or closure of the major duodenal papilla with a detachable snare., Main Outcome Measurements: Feasibility, efficacy, and safety of endoscopic methods to develop swine models with bile duct dilation were estimated by degree of dilation at the common bile duct (CBD), intrahepatic duct (IHD), and gallbladder (GB)., Results: All animals survived until the end of the experiment. Clipping of the major duodenal papilla and closure of the major duodenal papilla with a detachable snare were performed successfully in all swine. No technical difficulty or adverse event occurred during the procedures. Biliary dilatations in all animals were observed on cholangiograms (mean Δ% of postprocedural and preprocedural maximum diameters: CBD, 301%; IHD, 223.5%; GB, 34.8%). Degree of bile duct dilation in the snare group tended to be greater (CBD, 367.3%; IHD, 298.3%; GB, 47.8%) than in the endoclip group (CBD, 234.7%; IHD, 148.7%; GB, 21.8%), but this difference was not significant. An analysis of degrees of dilation according to location in the biliary tree showed that the GB was not dilated as well as the CBD or IHD., Limitations: Animal model., Conclusion: The 2 endoscopic procedures described are effective and safe for creating a swine model of bile duct dilation and could be helpful for training biliary intervention and for endoscopic biliary studies., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: A lumen-apposing stent can be used effectively under endosonographic guidance., Objective: To evaluate a newly designed, fully covered self-expandable metal stent with folding anchoring flanges for lumen apposition assembled on a conventional delivery system., Design: Retrospective case series and animal study., Setting: Tertiary care academic medical centers., Subjects: Six pigs for animal study and 7 patients, 3 of whom underwent endoscopic drainage for acute cholecystitis (AC) and 4 for pancreatic fluid collection (PFC)., Intervention: Stent deployment under EUS guidance after puncturing, passage of an endoscope through the stent into the gallbladder (GB), or PFC with conventional endoscopic procedures., Main Outcome Measurements: Technical and clinical success, adverse events, and removability., Results: In the animal study, the stent was successfully inserted and deployed in the GB via a transgastric approach under EUS guidance without adverse events in all 6 pigs. Contrast injection demonstrated the absence of leakage. Cholecystoscopy with enhanced endoscopy was performed successfully in all animals after stent placement. All stents were intact and were removed successfully at 4 weeks. GB firmly adhered to the stomach with an intact cholecystogastric tract on necropsy and histopathology. The stents were successfully deployed without adverse effects in 7 patients. AC or PFC was resolved after stent placement in all patients. Endoscopic procedures were possible through the stent. Stent migration was not observed. The stent was successfully removed from the 4 patients with PFC after complete resolution., Limitations: Small sample size, retrospective study., Conclusions: Transenteric drainage and endoscopic intervention by using a novel fully covered self-expandable metal stent for lumen apposition under EUS guidance is feasible for the management of AC and PFC. Further study is warranted., (Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Surgical gastrojejunostomy is associated with relatively high morbidity and mortality rates. However, current experimental EUS-guided gastrojejunostomy information is limited., Objective: To evaluate a novel EUS-guided gastrojejunostomy technique using a new enteric balloon and lumen-apposing metal stent., Design: Animal experiment., Setting: Animal laboratory at a referral center., Subjects and Interventions: In 5 pigs, gastrojejunostomies were created under EUS guidance. Fully covered lumen-apposing stents were placed between the stomach and the jejunum., Main Outcome Measurements: Technical success and adverse events of EUS-guided gastrojejunostomy., Results: All stents, with 1 exception, were successfully deployed without any adverse events. The mean time to stent placement was 44.2 minutes (range 28-64 minutes). All animals showed normal eating behavior without signs of infection for 1 month after the procedure. Endoscopic imaging of the stomach site showed the stent to be patent and stable, without dislodgment, in all of the pigs. Necropsy showed complete adhesion between the stomach and the jejunum wall., Limitations: Pilot study., Conclusions: Creation of an EUS-guided gastrojejunostomy by using a novel enteric balloon and metal stent appears to be promising as a minimally invasive treatment., (Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Post-ERCP pancreatitis (PEP) is the most common and serious complication of ERCP. Difficult biliary cannulation can be a procedure-related risk factor for PEP. Recent studies reported that a prophylactic pancreatic stent (PS) can reduce the frequency and severity of PEP., Objective: To evaluate the efficacy and usefulness of a temporary 3F PS to prevent PEP in patients with difficult biliary cannulations., Design: A multicenter, prospective, randomized study., Setting: Two tertiary-care academic medical centers., Patients: In total, 101 patients with a difficult biliary cannulation were randomly divided into the 3F PS placement group (PS group, n = 50) or the nonstent (NS) group (NS group, n = 51)., Interventions: Endoscopic placement of a 3F unflanged PS., Main Outcome Measurements: The incidence and severity of PEP in the 2 groups, spontaneous dislodgment of stents, and procedure-related complications., Results: The technical success rate of 3F PS placement was 96% (48/50). The lengths of the stents were 4 cm (n = 21), 6 cm (n = 15), and 8 cm (n = 12). Spontaneous stent dislodgment within 7 days occurred in 94% of patients (45/48). The mean duration until spontaneous dislodgment was 3.5 days. The incidence rate of PEP was 12% (6/50: mild, 5; moderate, 1) in the PS group and 29.4% (15/51: mild, 12; moderate, 2; severe, 1) in the NS group. Severe pancreatitis occurred in only 1 patient in the NS group. In a multivariate analysis, prophylactic placement of PS was the only prophylactic factor for PEP (odds ratio, 0.126; 95% CI, 0.025-0.632, P = .012)., Limitations: No comparative results for stent size and diameter and a low-risk cohort group., Conclusions: Prophylactic temporary 3F PS placement in patients with a difficult biliary cannulation during ERCP seems to be a safe and effective method for reducing PEP and results in a high rate of spontaneous passage of stents without complications., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Endoscopic placement of fully covered self-expandable metal stents (FCSEMS) has been attempted to manage benign biliary strictures, but currently available FCSEMSs may be associated with unintended complications, including de novo strictures, in patients with normal life expectancy., Objective: To evaluate the feasibility of an intraductally placed modified FCSEMS to minimize stent-induced bile duct injury in patients with benign biliary strictures., Design: Prospective observational clinical feasibility study., Setting: Tertiary-care academic center., Patients: This study involved 21 patients with symptomatic benign biliary strictures in whom conventional endoscopic management failed., Intervention: Strictured segments were 15 mm above the ampulla of Vater. The modified FCSEMS has convex margins, a lasso, and an anti-migrating waist on the central portion. Stents were placed entirely above the papilla and removed after 3 to 5 months., Main Outcome Measurements: Success, complications, removability, midterm outcome., Results: FCSEMSs were successfully placed inside the bile duct in all patients. No episodes of pancreatitis, cholangitis, or sepsis were noted during the stenting period. Stent migration occurred in 4 patients (19.0%), but 3 were asymptomatic during follow-up. All stents were removed successfully with rat-tooth forceps without complications. Post-stenting cholangiograms showed improvement of strictures in 20 of 21 patients, without de novo focal stricture. The clinical success rate was 95.2%, with one recurrent stricture., Limitations: The small number and lack of comparison with other types of FCSEMSs., Conclusion: Temporary intraductal placement of a newly modified FCSEMS effectively improved strictures and prevented potential stent-induced complications in patients with benign biliary strictures. Controlled large-scale trials are needed to confirm the long-term efficacy., (Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: EUS is useful for diagnosis of GI disease. However, artifacts caused by gastric mucus may worsen visibility during EUS., Objective: To investigate the efficacy of premedication with pronase, the proteolytic enzyme, for improving imaging during EUS., Design: Blinded, randomized, prospective study., Setting: Tertiary-care referral center., Patients: This study involved 183 patients scheduled for EUS., Intervention: Patients were assigned to oral premedication with saline solution (group A), pronase and bicarbonate (group B), or pronase, bicarbonate, and simethicone (group C). Either conventional EUS or high-frequency catheter EUS (HFUS) was selected. Gastric cavity and gastric mucosal surface obscurity grades were assessed by using visibility scores from ultrasonographic images of each patient., Main Outcome Measurements: Means of visibility scores and proportion of images with better visibility scores of the gastric cavity and gastric mucosal surface. Lower scores indicate better visibility of the gastric mucosal surface and fewer artifacts within the gastric cavity on conventional EUS and HFUS., Results: Group B had significantly lower mean gastric cavity and gastric mucosal surface visibility scores than did groups A and C in both conventional EUS and HFUS. Group B also had a high proportion of images that had better gastric cavity and gastric mucosal surface visibility scores than did the other two groups in conventional EUS and HFUS., Limitations: Small number of patients and no assessment of the amount of mucus before oral premedication., Conclusion: Premedication for conventional EUS and HFUS by using a mixture of pronase and bicarbonate seems to decrease the number of gastric wall and lumen hyperechoic artifacts observed in patients given either saline solution or pronase/bicarbonate/simethicone., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Direct peroral cholangioscopy (POC) by using an ultra-slim endoscope provides direct visualization of the bile duct and allows for therapeutic intervention. Holmium laser lithotripsy can be effective for retained bile duct stones, but it requires direct visualization during the procedure for safe and effective fragmentation. Direct POC by using an ultra-slim endoscope may facilitate holmium laser lithotripsy., Objective: To evaluate the feasibility, success rates, and complications of holmium laser lithotripsy under direct POC by using an ultra-slim endoscope for retained bile duct stones., Design: Observational clinical feasibility study., Setting: Tertiary-care referral center., Patients: This study involved 13 patients with retained bile duct stones whose treatment failed by a conventional lithotripsy method involving mechanical lithotripsy., Intervention: Holmium laser lithotripsy under direct POC by using an ultra-slim endoscope., Main Outcome Measurements: Success rate of complete stone removal and procedure-related complications., Results: Holmium laser lithotripsy under direct POC by using an ultra-slim endoscope was successful in 11 of 13 patients (84.6%). Although direct POC was successful, holmium laser lithotripsy failed in 2 patients because of inaccurate targeting of the laser fiber to stones. There were no procedure-related complications except one case of mild pancreatitis., Limitations: A small number of patients and no comparison with other lithotripsy systems., Conclusion: Holmium laser lithotripsy under direct POC by using an ultra-slim endoscope was feasible and can be a safe endoscopic management method for retained bile duct stones., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: The cause of pancreatitis is unknown in as many as 30% of cases of recurrent acute pancreatitis, even after ERCP., Objective: To investigate the role of intraductal US (IDUS) for managing idiopathic recurrent pancreatitis (IRP)., Design: Prospective study., Setting: Tertiary referral hospital., Patients: Thirty-one patients with suspicious IRP with negative findings on ERCP., Interventions: IDUS during ERCP., Main Outcome Measurements: IDUS findings showing any possible cause of pancreatitis., Results: IDUS revealed small bile duct stones (≤3 mm) in 5 patients (16.1%) and sludge in 3 patients (9.7%). The detection rate for a bile duct stone and sludge was significantly higher in patients with a dilated CBD than a nondilated CBD on ERCP (71.4 vs 12.5%; P < .05). Recurrent pancreatitis did not develop in 7 of 8 patients with biliary stones or sludge after an endoscopic sphincterotomy (EST). Two patients (6.5%) demonstrated a small polypoid lesion on the distal end of the pancreatic duct. One patient underwent surgery for intra-ampullary cancer, and another one underwent EST without another attack of pancreatitis. Three patients (9.7%) showed evidence of chronic pancreatitis with small pancreatic stones and/or calcifications on IDUS., Limitations: Small number of patients. IDUS results were not compared with those of conventional EUS. There was no reference standard for chronic pancreatitis as diagnosed by IDUS., Conclusions: IDUS identified a possible cause of idiopathic recurrent pancreatitis in 42% of patients with negative findings on ERCP. The IDUS-guided approach combined with ERCP and EST may be useful for decreasing recurring attacks of pancreatitis., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Photodynamic therapy (PDT) has emerged as a promising palliative treatment for inoperable cholangiocarcinoma. Cholangioscopy-guided PDT can be useful for identification of tumor margins, determination of the appropriate location for placement of the diffuser, and evaluation of the patient's response to therapy., Objective: To evaluate the feasibility of PDT under direct peroral cholangioscopy (POC) by using an ultra-slim upper endoscope in patients with inoperable cholangiocarcinoma., Design: Prospective, observational, pilot study., Setting: Single tertiary-care referral center., Patients: This study involved 9 patients with inoperable extrahepatic cholangiocarcinoma., Intervention: Photofrin II was administered intravenously 48 hours before PDT. Additional PDT was performed up to 48 hours after the initial application of therapy. A successful direct POC-guided PDT was defined as advancement of the endoscope into the distal margin of the tumor and maintenance of endoscope position until PDT was completed., Main Outcome Measurements: The clinical feasibility, usefulness, and complications of direct POC for PDT., Results: Seventeen sessions of direct POC for PDT were performed in 9 patients. PDT was performed successfully in 15 of 17 sessions (88.2%) and 7 of 9 patients (77.8%). Biliary drainage under direct POC, if necessary after PDT, was possible in 100% of patients (7/7). Follow-up direct POC confirmed significant tumor ablation after PDT in 5 patients. One patient reported mild skin redness; no major procedure-related complications were observed., Limitations: Small sample size, pilot study., Conclusion: Direct POC-guided PDT by using an ultra-slim upper endoscope seems to be both feasible and safe in select patients with inoperable extrahepatic cholangiocarcinoma., (Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.)

Background: Very few clinical trials have reported on the success rate of frequency-doubled double-pulse yttrium aluminum garnet (YAG) laser (FREDDY) technology for removal of difficult bile duct stones., Objective: Our purpose was to evaluate the role of FREDDY technology for removing difficult bile duct stones., Design: Nonrandomized, retrospective study., Setting: Academic medical center., Patients: Fifty-two patients with difficult bile duct stones were treated via the transpapillary route by using a FREDDY system. The inclusion criteria were impacted or large common bile duct stones (>15 mm, mean 23.5 mm, range 15-35 mm, mean number of stones 1.7, range 1-4). Laser lithotripsy was performed with cholangioscopy guidance in 7 patients and fluoroscopic guidance alone in 45 patients., Main Outcome Measurements: The success rate of complete stone removal and the complication rate related to the procedure., Results: Of the 52 patients treated via the transpapillary route, complete stone removal was achieved in 48 patients (92.3%). The complete removal of stones required a mean of 1.4 (range 1-2) endoscopic sessions. The rate of complications related to laser lithotripsy was 23.0% (acute pancreatitis, 3 cases; transient hemobilia, 8 cases; acute cholangitis, 1 case)., Limitations: Nonrandomized, retrospective design., Conclusion: Laser lithotripsy by using the FREDDY system seems safe and effective and allows "blind" fragmentation of bile duct stones under fluoroscopic guidance only.

Background: Self-expandable metal stents (SEMSs) are an effective palliative treatment for malignant biliary or duodenal strictures, but endoscopic stenting for combined malignant biliary and duodenal obstruction remains technically difficult., Objective: To evaluate the feasibility and clinical success rate of endoscopic double stent-in-stent placement by using a new duodenal metallic stent for the management of malignant biliary and duodenal obstructions., Design: Prospective, observational clinical feasibility study., Setting: Tertiary referral center., Main Outcome Measurement: Technical and clinical success, complications, midterm outcome., Patients and Methods: Eight patients with inoperable malignant biliary and duodenal strictures were enrolled. Endoscopic placement of a biliary SEMS was performed through the mesh of the duodenal stent., Results: The duodenal strictures were in the first part of the duodenum in 3 patients (type 1) and in the second part in 5 patients (type 2). Duodenal stents were successfully deployed in all patients. Endoscopic placement of a biliary SEMS through the mesh of the duodenal stent was successful in 7 (87.5%) of 8 patients. In 2 of 3 patients with type 2 duodenal strictures with failed bile duct cannulation, biliary stenting was successful by using the rendezvous procedure. Early complications occurred in 1 patient. The overall median survival after combined stenting was 91 days (range 36-314 days)., Limitations: Small number of patients and no comparison with other enteral stents., Conclusions: Biliary stenting through the new duodenal metallic stent is technically feasible and has a high success rate. Combined endoscopic biliary and duodenal stent-in-stent placement is a promising solution for the palliation of malignant biliary and duodenal obstruction.

Background: Peroral cholangioscopy (POC) provides direct visualization of the bile duct and facilitates diagnostic procedures and therapeutic intervention. The currently available mother-baby endoscope system is not widely used because of several limitations. Although direct cholangioscopy with an ultraslim upper endoscope with a guidewire has been reported, success is not always guaranteed., Objective: To evaluate the feasibility and success rate of direct POC using an ultraslim endoscope with an intraductal balloon to maintain access compared with the guidewire method., Design: Prospective, observational clinical feasibility study., Setting: Tertiary referral center., Main Outcome Measurements: We compared overall procedure success rates and complications. A successful procedure was defined as one in which the endoscope was advanced into the bifurcation or stenotic segment of the biliary system., Patients and Methods: Twenty-nine patients with biliary disease underwent direct POC. All patients had previously undergone an endoscopic sphincterotomy or papillary balloon dilation with a large balloon. Eleven patients underwent wire-guided direct POC. Intraductal balloon-guided direct POC was performed in 21 patients. The balloon catheter was used to maintain access while an ultraslim upper endoscope was advanced over the balloon catheter, through the ampulla of Vater, and directly into the bile duct., Results: Wire-guided direct POC was successful in 5 of 11 (45.5%) patients. In contrast, the success rate of intraductal balloon-guided direct POC was 95.2% (20/21 patients, P < .05). Forceps biopsies under direct visualization of the intraductal lesion and therapeutic intervention, including laser lithotripsy or electrohydraulic lithotripsy, were performed successfully. Procedure-related complications were not observed., Limitations: A small number of patients and no comparison with conventional cholangioscopy., Conclusions: Intraductal balloon-guided direct POC with an ultraslim upper endoscope allows the direct visual examination and therapeutic intervention of bile ducts in patients with biliary disease. Further development of the endoscopic apparatus and specialized accessories are expected to facilitate this procedure.

Background: Endoscopic management of malignant hilar biliary strictures is difficult even for an experienced endoscopist. Moreover, endoscopic placement of bilateral metal stents is considered very difficult and complicated., Objective: We explored the feasibility and efficacy of the placement of a newly designed metal stent for an endoscopic bilateral stent-in-stent procedure for the management of malignant hilar biliary strictures., Design: Multicenter prospective feasibility study., Setting: Five academic tertiary referral centers., Patients: Thirty-five patients with malignant hilar biliary strictures of Bismuth type II or higher were enrolled., Interventions: Bilateral stent placement by an endoscopic stent-in-stent procedure., Main Outcome Measurements: Technical success, functional success, early and late complications, stent patency., Results: The overall technical success rate of the newly designed metal stent was 94.3% (33/35). The success rate of the stent-in-stent procedure in a single session was 82% (27/33) per protocol and 77% (27/35) as intent to treat. In cases in which the initial stent-in-stent procedure failed, patients underwent the endoscopic stent-in-stent procedure for contralateral stent placement at 2 days (6%, 2/33) or 4 days (12%, 4/33) after the initial stent placement. There was no percutaneous insertion of a contralateral stent in these patients. There was no stent-related early or late complication in any enrolled patient. Functional success was 100% (33/33). Reintervention because of stent malfunction was 6% (2/33). These 2 patients showed sludge formation in the stent. During follow-up, there was no stent tumor ingrowth or overgrowth in the placed stent in any enrolled patient. According to the Kaplan-Meier analysis, median survival and stent patency were 180 days and 150 days, respectively., Limitations: An uncontrolled feasibility study with a small patient population and a limited follow-up period., Conclusion: The newly designed metal stent for the endoscopic bilateral stent-in-stent procedure may be feasible and effective for malignant hilar biliary strictures.

Background: The therapeutic approach in patients with sphincter of Oddi (SO) dysfunction (SOD) aims to reduce the resistance to the flow of bile or pancreatic juice. Vardenafil inhibits the activity of phosphodiesterase type 5 (PDE-5), which degrades cyclic guanossine monophosphate (cGMP) and results in relaxation of smooth muscle., Objective: The present study was performed to determine the effects of vardenafil on SO motility in patients with suspected SOD., Design: Prospective study., Settings: Single university center., Patients and Interventions: Twenty consecutive adult patients with suspected SOD were scheduled to undergo ERCP and SO manometry by standard methods. A second recording was performed in the same position 20 minutes after administration of 10 mg vardenafil dissolved in 10 mL saline solution into the duodenum through a conventional catheter. SO pressures and motor function were compared in all patients with suspected SOD before and after administration of vardenafil., Results: After administration of 10 mg of vardenafil, the mean basal sphincter pressure was reduced from 59.5 to 26.9 mm Hg (P < .001), and the mean phasic amplitude was reduced from 132.2 to 66.2 mm Hg (P < .001). The mean phasic wave frequency was not changed after administration of vardenafil (7.2/min vs 6.6/min, respectively, P = .07). These results did not differ between SOD types. No significant difference in manometric data were detected before and after administration of vardenafil between cholecystectomy and gallbladder in situ groups. Transient headache was observed in 1 patient, and the procedure-related complication was post-ERCP pancreatitis (n = 2 [10%])., Limitations: The small sample size and uncontrolled study., Conclusion: Vardenafil inhibits SO motility in patients with suspected SOD and reduces basal SO pressure, without significant adverse effects.

Background: Selective cannulation in patients with a Billroth II gastrectomy is still challenging., Objective: To evaluate the usefulness of a multibending, forward-viewing endoscope (M-scope) for selective cannulation during diagnostic or therapeutic ERCP in patients with a Billroth II gastrectomy., Design: Case series., Setting: Tertiary center., Patients: Fourteen patients having biliary disease with a Billroth II gastrectomy in whom selective cannulation failed when using a conventional forward-viewing endoscope., Interventions: In all cases, we attempted selective biliary cannulation for ERCP with a single-bending, forward-viewing endoscope for 10 minutes. After failure with the conventional endoscope, we retried selective cannulation with the M-scope for 10 minutes. After cannulation, the diagnostic or therapeutic endoscopic procedures were performed., Main Outcome Measurements: We assessed the success rate of selective cannulation, the possibility of therapeutic approaches, and procedure-related complications., Results: In all cases, we successfully reached the ampulla of Vater with the M-scope. The overall success rate of selective cannulation with the M-scope was 92.9% (13/14). One patient developed mild pancreatitis. Therapeutic procedures such as sphincterotomy, balloon dilatation, stone removal, and biliary drainage were all possible., Limitations: Small number of patients; uncontrolled, single-center study., Conclusions: The M-scope seems to be helpful for selective cannulation during ERCP in patients with a Billroth II gastrectomy. All diagnostic and therapeutic procedures were possible through the M-scope.

Background: The "mother-baby" endoscope system currently used for peroral cholangioscopy (POC) has several limitations. Endoscopic direct cholangioscopy when using an ultra-slim upper endoscope with a guidewire to maintain access has been reported, but appropriate accessories are required to increase the success rate. Herein, we describe a novel method, overtube-balloon-assisted endoscopy, for direct POC., Objective: To evaluate the feasibility and usefulness of direct POC when using an ultra-slim upper endoscope with an overtube balloon to maintain access., Setting: A single center., Design: Case series., Patients: Twelve patients with biliary disease., Interventions: Direct POC by using an ultra-slim upper endoscope and diagnostic and/or therapeutic procedures., Main Outcome Measurements: Success rate of this technique, diagnostic or therapeutic feasibility, and complications., Results: Overtube-balloon-assisted direct POC was performed successfully in 10 of 12 patients (83.3%). The procedure revealed 4 common bile duct (CBD) stones, 4 benign biliary strictures, 1 polypoid tumor, and 1 cholangiocarcinoma. Five patients underwent forceps biopsy under direct visualization of the intraductal lesion. Laser lithotripsy was successfully performed in 1 patient. No procedure-related complication occurred., Limitations: A small number of patients and no comparison with conventional cholangioscopy., Conclusions: The overtube balloon appears to be a useful accessory in direct POC when using an ultra-slim upper endoscope. However, further development of a slim overtube or other accessories is necessary to improve the success rate of direct POC.

Background: Endoscopic excision for adenoma of the major duodenal papilla was introduced as an alternative to surgery, but postprocedure pancreatitis is a serious drawback. This study assessed the feasibility and the safety of endoscopic papillectomy with a guidewire and pancreatic-duct stent insertion to prevent pancreatitis., Methods: Six patients were enrolled. The snare loop was passed over a guidewire that had been inserted into the pancreatic duct. Immediately after snare resection, a pancreatic stent was placed along the indwelling guidewire., Results: En bloc papillectomy and pancreatic stent insertion were performed successfully in all patients. Pancreatitis did not develop acutely in any patient. Complications included cholangitis (n = 1) and late-onset pancreatitis owing to the pancreatic stent (n = 1). Scant residual adenomatous tissue was present at resection margins in two patients and was treated endoscopically., Conclusions: Wire-guided endoscopic snare papillectomy in selected patients is a useful technique that maintains pancreatic-duct access for stent placement. This appears to prevent pancreatitis and to improve the outcome for patients undergoing endoscopic resection of papillary tumors.

Background: Electrohydraulic lithotripsy is a highly effective method for fragmenting biliary stones, but direct visual control is required. The efficacy and the safety of electrohydraulic lithotripsy without cholangioscopy by using a balloon catheter were evaluated in patients with bile-duct stones that could not be extracted by using standard techniques., Methods: Nineteen patients with extrahepatic bile-duct stones that could not be extracted by using conventional endoscopic methods, e.g., mechanical lithotripsy, were selected to undergo electrohydraulic lithotripsy without peroral cholangioscopy. An electrohydraulic lithotripsy probe with a 3.0 F radio-opaque tip was inserted through a balloon catheter. Electrohydraulic lithotripsy was performed under fluoroscopy until the fragmented stone could be captured in a large basket for mechanical lithotripsy. Endoscopic removal of the fragments was attempted during the electrohydraulic lithotripsy session., Results: Stones were successfully fragmented in 17 of 19 patients. In 16 patients (84.2%), the bile duct was cleared of all stones. A mean of 1.8 endoscopic sessions was required for complete removal. Additional mechanical lithotripsy was performed in 9 (56.2%) of the 16 patients. Minor complications were noted in 4 patients (2 hemobilia, 1 pancreatitis, 1 cholangitis). There was no 30-day mortality., Conclusions: For a selected group of patients with bile-duct stones not extractable by using standard techniques, fluoroscopically controlled electrohydraulic lithotripsy with a balloon catheter seems to be an effective method of fragmentation.

Background: Mirizzi syndrome refers to common hepatic duct obstruction caused by extrinsic compression that is usually from a stone impacted in the cystic duct. The utility of transpapillary intraductal US for assessment of biliary strictures with radiographic features of Mirizzi syndrome was studied retrospectively., Methods: Intraductal US was performed in 16 patients with a common hepatic duct stricture caused by extrinsic compression and nonvisualization of the gallbladder by endoscopic retrograde cholangiography. An over-the-wire catheter US probe (20 MHz) was inserted into the bile duct. Intraductal US findings were compared with the final diagnoses at surgery., Results: Intraductal US was successful in all patients. The extraluminal cause of the common hepatic duct stricture was detected in 14 patients (87.5%). In 9 patients, intraductal US detected an impacted stone outside the common hepatic duct. Intraductal US demonstrated extraluminal lesions without evidence of a stone in 5 patients, including a mass in 4 and asymmetrical, irregular thickening of the bile duct wall in 1 patient. In the remaining 2 patients, intraductal US demonstrated only a distended gallbladder., Conclusions: Transpapillary wire-guided intraductal US is useful for assessing biliary strictures with features that suggest Mirizzi syndrome and optimizes management of patients with these findings.

Background: Bleeding from gastric varices larger than 2 cm in diameter represents a major limitation for endoscopic hemostasis., Methods: Endoscopic ligation of gastric varices was performed with detachable snares and elastic bands in 41 patients who had recent bleeding from gastric varices larger than 2 cm in diameter. Gastric varices larger than 2 cm were ligated with detachable snares, and then adjacent small gastric varices were ligated with elastic bands., Results: Among the 41 patients, 10 of 12 patients with active bleeding and 28 of 29 patients with red color signs at initial endoscopy were successfully treated by endoscopic ligation by using detachable snares and elastic bands. Bleeding recurred early (before variceal eradication) in 4 of 38 patients (10.5%). The overall hemostatic rate for endoscopic ligation was 82.9% (34/41). In 33 of 36 patients (91.7%) who underwent repeated ligation treatments, variceal eradication was nearly complete. Mean follow-up in 30 of 33 patients after eradication of varices was 16.4 months (3-32 months), and 29 of 30 did not have recurrent bleeding. During and after ligation there were no serious complications., Conclusions: Endoscopic ligation therapy with large detachable snares and elastic bands is safe and effective for treatment of large bleeding gastric varices.