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Background: Same-session endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) is an attractive policy for patients with distal malignant biliary obstruction (DMBO) requiring fine-needle biopsy (FNB) and biliary drainage. However, scanty and conflicting data exists regarding safety and efficacy when comparing these two procedures performed in same versus separate sessions. Methods: Single-center, retrospective, propensity score-matched study including patients with DMBO who underwent EUS-FNB followed by ERCP during the same or separate sessions. The primary outcome was the safety of the procedure [number of patients experiencing adverse events (AEs), overall AEs, its severity, post-ERCP pancreatitis (PEP)]. Secondary outcomes were successful ERCP, use of advanced cannulation techniques, EUS-FNB adequacy, length of hospital stay, overall procedure time, and time to recurrent biliary obstruction. Results: After propensity matching, 87 patients were allocated to each group. AEs developed in 23 (26.4%) vs. 17 (19.5%) patients in the same and separate sessions group, respectively (p = 0.280). The overall number, the severity of AEs, and the rate of PEP were similar in the two groups. Secondary outcome parameters were also comparable in the 2 groups. Conclusions: Same-session EUS-FNB followed by ERCP with biliary drainage is safe and does not impair technical outcomes of tissue adequacy and biliary cannulation. [ABSTRACT FROM AUTHOR]

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

Abstract Background 10‐mm self‐expandable metal stents (SEMSs) are commonly used for preoperative biliary drainage in pancreatic cancer. However, smaller diameter SEMSs have attracted attention with the attempt to reduce stent‐related adverse events (AEs). Methods We retrospectively analyzed consecutive borderline resectable pancreatic cancer patients who underwent neoadjuvant therapy and fully covered SEMS (FCSEMS) placement from April 2015 to May 2023. The primary outcome was stent‐related non‐event rate (NER), which was defined as the rate of completion of surgery without developing any preoperative events (recurrent biliary obstruction [RBO] or stent‐related AEs). Secondary outcomes included stent‐related AEs, causes of RBO, and cumulative incidence of RBO. Risk factors for pancreatitis, RBO, and stent migration were also examined. Results A total of 76 patients were included (6‐mm group: 23; 10‐mm group: 53). Stent‐related NER (57% vs. 64%, p = 0.610), stent‐related AEs (4% vs. 15%, p = 0.263), overall RBO rates (39% vs. 23%, p = 0.168), cumulative incidence of RBO (hazard ratio, 2.24; 95% confidence interval, 0.95–5.25; p = 0.065) were not significantly different between the two groups. Tumor involvement of the pancreatic duct was identified as a risk‐reducing factor for pancreatitis, while an FCSEMS diameter of 6 mm was not identified as a risk factor for RBO and stent migration. Conclusions Stent‐related NER was not significantly affected by FCSEMS diameter. Further studies are needed to confirm the usefulness of 6‐mm diameter FCSEMS for preoperative biliary drainage in patients with borderline resectable pancreatic cancer.

Background: The use of duckbill-type anti-reflux metal stents (DMS) in reinterventions after covered metal stent (CMS) dysfunction has been reported in patients with distal malignant biliary obstruction (MBO). However, the superiority of DMS over conventional CMS (c-CMS) has not been established. Therefore, we conducted this retrospective study to evaluate the long-term efficacy and safety of DMS as a second stent in comparison with c-CMS. Methods: We investigated consecutive patients with distal MBO due to unresectable pancreatic cancer who underwent reintervention after dysfunction of initial biliary CMS at our institution. We compared causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates of DMS and c-CMS in this stenting. Results: A total of 76 patients were included (DMS 41 and c-CMS 35). While overall RBO rates were similar between the two groups (46% vs. 63%, p = 0.172), RBO due to non-occlusion cholangitis tended to be less frequent in the DMS group than in the c-CMS group (2% vs. 14%, p = 0.089). Median TRBO was significantly longer in the DMS group (286 days vs. 112 days, p = 0.029). DMS was identified as the only significant risk factor for TRBO (hazard ratio, 0.52; p = 0.044). Overall AE rates were significantly lower in the DMS group (2% vs. 23%, p = 0.010), with non-occlusion cholangitis being the most common AE in the c-CMS group. Endoscopic reintervention was successfully performed in all patients in both groups, despite failed stent removal in 15% of patients in DMS group. Conclusions: DMS was associated with a significantly longer TRBO and lower rate of AEs compared with c-CMS in reinterventions after initial CMS dysfunction. DMS may be preferable to c-CMS as a second stent after biliary CMS dysfunction. [ABSTRACT FROM AUTHOR]

Background: Treatment for unresectable distal malignant biliary obstruction (DMBO) involves placing a 10‐mm covered self‐expandable metallic stent (CSEMS). In recurrent biliary obstruction (RBO), replacement of the CSEMS is recommended; however, the appropriate stent type remains unknown. We speculated that large‐bore CSEMSs would provide longer patency. We compared the efficacy of 10‐mm and 12‐mm CSEMS in patients with RBO. Methods: We retrospectively retrieved data on patients who underwent CSEMS replacement from the endoscopic database. We investigated the time to RBO (TRBO) after CSEMS replacement. The hazard ratio (HR) for the the second TRBO was estimated using the Cox proportional hazard model. The estimated median second TRBO was determined using the Kaplan‐Meier method. Results: Among the 493 patients with DMBOs treated with 10‐mm CSEMS, 48 and 29 patients underwent re‐intervention with 10‐mm and 12‐mm CSEMS, respectively. The use of 12‐mm CSEMS was inversely associated with second TRBO (multivariable‐adjusted HR, 0.62; 95% CI, 0.39‐0.98; P =.042). The estimated median second TRBO was greater with the 12 mm CSEMS than with the 10 mm variety (562 days vs 207 days; P =.019). Conclusion: The second intervention with 12‐mm CSEMS was associated with a longer TRBO. [ABSTRACT FROM AUTHOR]

Abstract Objectives Selection criteria for self‐expandable metal stents (SEMSs) with or without cover during palliative treatment of distal malignant biliary obstruction (DMBO) remain unclear. We evaluated factors associated with time to recurrent biliary obstruction (TRBO) in fully covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs). Methods We retrospectively analyzed consecutive patients with DMBO who received a SEMS. TRBO was determined using the Kaplan–Meier analysis, and complications were compared between the FCSEMS and UCSEMS groups. After TRBO‐associated factors were extracted using multivariate competing‐risks regression (CRR), propensity score‐adjusted CRRs were performed to verify their robustness. Results There were 180 patients (66 FCSEMSs and 114 UCSEMSs) enrolled in this study. There was no significant difference between median TRBO in the FCSEMS and UCSEMS groups (275 vs. 255 days, p = 0.67). Complications were more frequent in the FCSEMS than UCSEMS group (21.2% vs. 8.8%; p = 0.023). Multivariate CRR for TRBO‐associated factors revealed that “pancreatic ductal carcinoma (PDAC) treated with UCSEMS” was the only independent predictor of TRBO (p = 0.03). Similarly, the propensity score‐adjusted CRRs showed no significant difference in TRBO in “FCSEMS” vs “UCSEMS” (p = 0.96); however, there was a significant difference in “PDAC using UCSEMS” vs “other” (p = 0.043). In the palliative care group including any DMBO without chemotherapy, the first quartile of the TRBO of UCSEMS was 100 days. Conclusions UCSEMSs are a possible option for both patients with DMBO arising from PDAC and for patients with any DMBO receiving palliative care who should avoid SEMS‐related complications.

Abstract Background The usefulness of duckbill‐type anti‐reflux metal stent (DMS) in self‐expandable metal stent‐naïve pancreatic cancer (PC) patients has not been well‐studied. This study aimed to evaluate the efficacy and safety of DMS in such patients. Methods We analyzed consecutive patients with unresectable PC who received a covered metal stent (CMS) as the initial self‐expandable metal stent at our institution. Technical success, functional success, causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates were compared between DMS and conventional CMS (c‐CMS). Results A total of 69 patients were included (DMS: 28, c‐CMS: 41). Technical success, functional success, and AEs were similar between groups. Tumor ingrowth was more common in the DMS group (18% vs. 0%, p = 0.009), while non‐occlusion cholangitis tended to be more common in the c‐CMS group (0% vs. 15%, p = 0.074). Median time to RBO was similar between groups (276 vs. 273 days, p = 0.915). The anti‐reflux valve of DMS was found torn in 56% of patients. Endoscopic reintervention was successful in all cases, despite failed stent removal in 88% of patients in the DMS group. Conclusions DMS was not associated with longer time to RBO compared to c‐CMS in self‐expandable metal stent‐naïve patients.

Background: Stent migration and sludge formation remain significant problems associated with covered self-expandable metal stents (CSEMSs). The EGIS biliary stent fully covered flare type (EGIS biliary stent), a new type of polytetrafluoroethylene-coated self-expandable metal stent with low axial force and an anti-migration system, was developed to overcome these disadvantages. We conducted this study to evaluate the efficacy and safety of this stent in comparison with conventional CSEMS (c-CSEMS)., Methods: We retrospectively analyzed consecutive patients with unresectable pancreatic cancer who received initial CSEMS for distal malignant biliary obstruction. The primary outcome was time to recurrent biliary obstruction (RBO). Secondary outcomes included technical success rate, functional success rate, stent-related adverse events, causes of RBO, and re-intervention., Results: A total of 40 patients were included (EGIS group: 20; c-CSEMS group: 20). The technical and functional success rates were similar between the two groups. Stent-related adverse event rates (20% vs. 15%, p > 0.99) and overall RBO rates (56% vs. 50%, p > 0.99) were not significantly different between the two groups. Stent migration was the most common cause of RBO in the EGIS group, while stent occlusion was in the c-CSEMS group. The median time to RBO (102 vs. 434 days, p = 0.10) was not significantly different between the two groups. Endoscopic transpapillary re-intervention was successful in most patients in both groups., Conclusions: The EGIS biliary stent was not associated with a longer time to RBO compared to c-CSEMS. Further improvements, especially against stent migration, are needed to improve its efficacy., Competing Interests: Tsuyoshi Takeda received honoraria from Boston Scientific Japan and SB‐Kawasumi Laboratories. Takashi Sasaki received honoraria from Boston Scientific Japan, Century Medical, SB‐Kawasumi Laboratories, JAPAN LIFELINE, and KANEKA MEDIX. Naoki Sasahira received honoraria from SB‐Kawasumi Laboratories., (© 2024 The Author(s). DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Introduction: Self-expandable metallic stents (SEMS) have been widely placed for unresectable distal malignant biliary obstruction (UDMBO). However, the dysfunction rate is 19-40% and its treatment is controversial. We aimed asses the efficacy and safety of a secondary biliary stents (uncovered (UC) versus fully-covered (FC) stent) for the management of occluded SEMS., Patients and Methods: Between 2015 and June 2023, 41 patients with UDMBO underwent secondary biliary stent placement as "stent-in-stent" (20 FCSEMS and 21 UCSEMS). The primary outcomes were technical and clinical success of SEMS placement. Secondary outcomes included adverse events (AEs), patency and survival. Patients were prospectively followed until death or loss of follow-up., Results: Technical (100% vs 85.5%) and clinical (100% vs 95.2%) success rates were similar in FCSEMS and UCSEMS groups. The median follow-up period was 510 days (range 290-630). The median duration of stent patency of FCSEMS (220 days, IQR 137.5-442.5) was longer than UCSEMS (150 days, IQR 110-362.5) (P=0.395), although stent dysfunction within 6 months was not different between groups. Multivariate analysis indicated that sex (HR=0.909, 0.852-0.970), antitumor treatment (HR=0.248, 0.032-0.441), stent patency (HR=0.992, 0.986-0.998) and clinical success (HR=0.133, 0.026-0.690) were significant factors for overall survival. There were no remarkable differences in AEs., Conclusions: The placement of additional biliary stent using the stent-in-stent method is an effective and safe rescue treatment for patients with UDMBO and occluded stent. In addition, the use of FCSEMS compared UCSEMS has unclear benefits regarding stent patency and overall survival., (Copyright © 2024 Elsevier España, S.L.U. All rights reserved.)

Background and Aim: Two methods of transpapillary covered self‐expandable metal stent (SEMS) placement are used for distal malignant biliary obstruction (MBO): after initial drainage by plastic stent (two‐step method) and without previous drainage (one‐step method). Methods: In total, 90 patients with unresectable pancreatic cancer and distal MBO were enrolled in this prospective multicenter randomized study and allocated to one‐step (n = 45) and two‐step (n = 45) groups. The main outcome was the time to recurrent biliary obstruction (TRBO). Secondary outcomes were the rates of early and late adverse events, survival time, the time required for bilirubin level reduction, and cost‐effectiveness. Results: The median TRBO did not differ significantly between the one‐step and two‐step groups (not available vs 314 days, P = 0.134). SEMS migration occurred significantly more frequently in the two‐step group (14.3% vs 0%, P = 0.026). No significant difference was observed between groups in early (7.3% vs 14.3%, P = 0.483) or late (12.2% and 11.9%, P = 1) adverse events other than RBO, survival time (P = 0.104), or the median number of days required to reach a bilirubin level considered to be acceptable for chemotherapy administration (<3 mg/dL; P = 0.881). The total costs of stent placement and reintervention were significantly lower in the one‐step SEMS group (3347 vs 5465 US dollars, P < 0.001). Conclusions: The superiority of TRBO with two‐step SEMS placement was not demonstrated. One‐step SEMS placement might be a promising method from the viewpoints of cost‐effectiveness and less invasiveness (UMIN‐CTR clinical trial registration number: UMIN000016010). [ABSTRACT FROM AUTHOR]

Background: 10-mm self-expandable metal stents (SEMSs) are commonly used for preoperative biliary drainage in pancreatic cancer. However, smaller diameter SEMSs have attracted attention with the attempt to reduce stent-related adverse events (AEs)., Methods: We retrospectively analyzed consecutive borderline resectable pancreatic cancer patients who underwent neoadjuvant therapy and fully covered SEMS (FCSEMS) placement from April 2015 to May 2023. The primary outcome was stent-related non-event rate (NER), which was defined as the rate of completion of surgery without developing any preoperative events (recurrent biliary obstruction [RBO] or stent-related AEs). Secondary outcomes included stent-related AEs, causes of RBO, and cumulative incidence of RBO. Risk factors for pancreatitis, RBO, and stent migration were also examined., Results: A total of 76 patients were included (6-mm group: 23; 10-mm group: 53). Stent-related NER (57% vs. 64%, p = 0.610), stent-related AEs (4% vs. 15%, p = 0.263), overall RBO rates (39% vs. 23%, p = 0.168), cumulative incidence of RBO (hazard ratio, 2.24; 95% confidence interval, 0.95-5.25; p = 0.065) were not significantly different between the two groups. Tumor involvement of the pancreatic duct was identified as a risk-reducing factor for pancreatitis, while an FCSEMS diameter of 6 mm was not identified as a risk factor for RBO and stent migration., Conclusions: Stent-related NER was not significantly affected by FCSEMS diameter. Further studies are needed to confirm the usefulness of 6-mm diameter FCSEMS for preoperative biliary drainage in patients with borderline resectable pancreatic cancer., Competing Interests: Tsuyoshi Takeda and Takafumi Mie received honoraria from Boston Scientific Japan. Takashi Sasaki received honoraria from Boston Scientific Japan, Cook Medical Japan, and Century Medical., (© 2024 The Authors. DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Background: Palliative endoscopic biliary drainage is the primary treatment option for the management of patients with jaundice which results from distal malignant biliary obstruction (DMBO). In this group of patients, decompression of the bile duct (BD) allows for pain reduction, symptom relief, chemotherapy administration, improved quality of life, and increased survival rate. To reduce the unfavorable effects of BD decompression, minimally invasive surgical techniques require continuous improvement., Aim: To develop a technique for internal-external biliary-jejunal drainage (IEBJD) and assess its effectiveness in comparison to other minimally invasive procedures in the palliative treatment of patients with DMBO., Methods: A retrospective analysis of prospectively collected data was performed, which included 134 patients with DMBO who underwent palliative BD decompression. Biliary-jejunal drainage was developed to divert bile from the BD directly into the initial loops of the small intestine to prevent duodeno-biliary reflux. IEBJD was carried out using percutaneous transhepatic access. Percutaneous transhepatic biliary drainage (PTBD), endoscopic retrograde biliary stenting (ERBS), and internal-external transpapillary biliary drainage (IETBD) were used for the treatment of study patients. Endpoints of the study were the clinical success of the procedure, the frequency and nature of complications, and the cumulative survival rate., Results: There were no significant differences in the frequency of minor complications between the study groups. Significant complications occurred in 5 (17.2%) patients in the IEBJD group, in 16 (64.0%) in the ERBS group, in 9 (47.4%) in the IETBD group, and in 12 (17.4%) in the PTBD group. Cholangitis was the most common severe complication. In the IEBJD group, the course of cholangitis was characterized by a delayed onset and shorter duration as compared to other study groups. The cumulative survival rate of patients who underwent IEBJD was 2.6 times higher in comparison to those of the PTBD and IETBD groups and 20% higher in comparison to that of the ERBS group., Conclusion: IEBJD has advantages over other minimally invasive BD decompression techniques and can be recommended for the palliative treatment of patients with DMBO., Competing Interests: Conflict-of-interest statement: The authors declare that they have no conflicts of interest to disclose., (©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.)

Background: Treatment for unresectable distal malignant biliary obstruction (DMBO) involves placing a 10-mm covered self-expandable metallic stent (CSEMS). In recurrent biliary obstruction (RBO), replacement of the CSEMS is recommended; however, the appropriate stent type remains unknown. We speculated that large-bore CSEMSs would provide longer patency. We compared the efficacy of 10-mm and 12-mm CSEMS in patients with RBO., Methods: We retrospectively retrieved data on patients who underwent CSEMS replacement from the endoscopic database. We investigated the time to RBO (TRBO) after CSEMS replacement. The hazard ratio (HR) for the the second TRBO was estimated using the Cox proportional hazard model. The estimated median second TRBO was determined using the Kaplan-Meier method., Results: Among the 493 patients with DMBOs treated with 10-mm CSEMS, 48 and 29 patients underwent re-intervention with 10-mm and 12-mm CSEMS, respectively. The use of 12-mm CSEMS was inversely associated with second TRBO (multivariable-adjusted HR, 0.62; 95% CI, 0.39-0.98; P = .042). The estimated median second TRBO was greater with the 12 mm CSEMS than with the 10 mm variety (562 days vs 207 days; P = .019)., Conclusion: The second intervention with 12-mm CSEMS was associated with a longer TRBO., (© 2022 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)

Background: The usefulness of duckbill-type anti-reflux metal stent (DMS) in self-expandable metal stent-naïve pancreatic cancer (PC) patients has not been well-studied. This study aimed to evaluate the efficacy and safety of DMS in such patients., Methods: We analyzed consecutive patients with unresectable PC who received a covered metal stent (CMS) as the initial self-expandable metal stent at our institution. Technical success, functional success, causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates were compared between DMS and conventional CMS (c-CMS)., Results: A total of 69 patients were included (DMS: 28, c-CMS: 41). Technical success, functional success, and AEs were similar between groups. Tumor ingrowth was more common in the DMS group (18% vs. 0%, p = 0.009), while non-occlusion cholangitis tended to be more common in the c-CMS group (0% vs. 15%, p = 0.074). Median time to RBO was similar between groups (276 vs. 273 days, p = 0.915). The anti-reflux valve of DMS was found torn in 56% of patients. Endoscopic reintervention was successful in all cases, despite failed stent removal in 88% of patients in the DMS group., Conclusions: DMS was not associated with longer time to RBO compared to c-CMS in self-expandable metal stent-naïve patients., Competing Interests: None., (© 2023 The Authors. DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Background: Self-expandable metal stents (SEMS) are widely utilized to relieve symptoms of malignant gastric outlet obstruction (GOO), but GOO is frequently complicated by nonresectable distal biliary obstruction. The optimal endoscopic approach to biliary drainage in this setting remains controversial and has yet to be resolved. Aims: To compare the safety and efficacy of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) and transpapillary drainage in patients with an indwelling duodenal SEMS. Methods: Patients who underwent EUS-BD or transpapillary drainage for distal malignant biliary obstruction with an indwelling duodenal SEMS between June 2007 and August 2012 at three Japanese tertiary referral centers were identified retrospectively. We compared times to stent dysfunction, causes of dysfunction, and procedural related complications between these two groups. Results: Twenty patients were included in the study (7 EUS-BD and 13 transpapillary drainage). EUS-BD was performed via hepaticogastrostomy using a SEMS in three patients and via choledochoduodenostomy using a SEMS or a plastic stent in two patients each. Transpapillary drainage was performed using a SEMS in all patients. The stent patency rate in the EUS-BD group was higher than that in the transpapillary drainage group (100 vs. 71 % at 1 month and 83 vs. 29 % at 3 months, respectively). The rate of stent dysfunction in the EUS-BD group tended to be lower than that in the transpapillary group (14 vs. 54 %; P = 0.157). Complication rates were similar between the groups ( P = 1.000), with moderate bleeding in one patient in the EUS-BD group and mild pancreatitis in one patient in the transpapillary group. Conclusion: Endoscopic ultrasound-guided transmural biliary drainage is an alternative to transpapillary drainage in patients with an indwelling duodenal SEMS. [ABSTRACT FROM AUTHOR]

Background Feasibility of antireflux metal stent ( ARMS), designed to prevent duodenobiliary reflux, was reported in patients with distal malignant biliary obstruction. In this prospective pilot study, we aimed to evaluate a newly designed ARMS as a reintervention for self-expandable metallic stent ( SEMS) occlusion believed to be caused by duodenobiliary reflux. Patients and Methods Patients with non-resectable distal malignant biliary obstruction were included in whom a prior SEMS was occluded as a result of sludge or food impaction between March 2010 and January 2012 at two Japanese tertiary referral centers. The occluded SEMS were endoscopically removed, if possible, and subsequently replaced by a newly designed ARMS. We evaluated the technical success rate and complications of ARMS and compared the time to occlusion of ARMS with that of prior SEMS. Results A total of 13 patients were included. ARMS was successfully placed in all patients in a single procedure. No procedure-related complications were identified. ARMS occlusion occurred in two patients (15%), the causes of which were sludge in one patient and unknown in the other. ARMS migration occurred in four patients (31%). ARMS patency time was significantly longer than that of prior SEMS (median, not available vs 58 days; P = 0.039). Conclusions This newly designed ARMS is a technically feasible, safe, and effective reintervention for SEMS occlusion as a result of sludge or food impaction. An anti-migration mechanism to improve the outcomes of ARMS should be considered. [ABSTRACT FROM AUTHOR]

Background Self-expandable metallic stent ( SEMS) placement is widely carried out for distal malignant biliary obstruction, and survival analysis is used to evaluate the cumulative incidences of SEMS dysfunction (e.g. the Kaplan- Meier [ KM] method and the log-rank test). However, these statistical methods might be inappropriate in the presence of 'competing risks' (here, death without SEMS dysfunction), which affects the probability of experiencing the event of interest ( SEMS dysfunction); that is, SEMS dysfunction can no longer be observed after death. A competing risk analysis has rarely been done in studies on SEMS. Patients and Methods We introduced the concept of a competing risk analysis and illustrated its impact on the evaluation of SEMS outcomes using hypothetical and actual data. Our illustrative study included 476 consecutive patients who underwent SEMS placement for unresectable distal malignant biliary obstruction. Results A significant difference between cumulative incidences of SEMS dysfunction in male and female patients via the KM method ( P = 0.044 by the log-rank test) disappeared after applying a competing risk analysis ( P = 0.115 by Gray's test). In contrast, although cumulative incidences of SEMS dysfunction via the KM method were similar with and without chemotherapy ( P = 0.647 by the log-rank test), cumulative incidence of SEMS dysfunction in the non-chemotherapy group was shown to be significantly lower ( P = 0.031 by Gray's test) in a competing risk analysis. Conclusion Death as a competing risk event needs to be appropriately considered in estimating a cumulative incidence of SEMS dysfunction, otherwise analytical results may be biased. [ABSTRACT FROM AUTHOR]

Background We aimed to clarify the clinical usefulness of one-step self-expandable metal stent ( SEMS) placement for distal malignant biliary obstruction by comparing with two-step SEMS placement. Methods We retrospectively compared early complications, bilirubin level decreasing rate, and period of hospitalization between 40 patients with one-step SEMS and 52 patients with two-step SEMS. We also evaluated the complications in patients with two-step SEMS by classifying them into first drainage ( ERBD or ENBD) and second drainage ( SEMS). Results The total incidence of early complications was significantly higher in patients with one-step SEMS than the second drainage of two-step SEMS (42.5% [17/40] vs. 13.5% [7/52]; P = 0.004). However, there was no significant difference in the early complications between one-step SEMS and two-step SEMS (total of first and second drainage) (42.5% [17/40] vs. 36.5% [19/52]; P = 0.561). The period required to reach the bilirubin level (<3 mg/dL) after initial drainage was significantly shorter in one-step SEMS than in two-step SEMS (5.7 vs. 10.1 days; P = 0.025). Similar results were observed in the period of hospitalization for patients without chemotherapy (22.2 vs. 37.3 days; P = 0.004). Conclusions One-step SEMS placement is the alternative option of drainage method for distal malignant biliary obstruction. [ABSTRACT FROM AUTHOR]

Endoscopic placement of a self-expandable metal stent ( SEMS) has become a mainstream treatment to relieve non-resectable distal malignant biliary obstructions-its longer patency and cost-effectiveness were demonstrated in comparison with plastic biliary stents in several randomized controlled trials. Despite advances in ERCP devices and SEMSs themselves to enable safe and effective biliary drainage via a SEMS, several significant aspects of the endoscopic placement of SEMS must be considered; otherwise, SEMS-related complications and early SEMS dysfunction may occur. Also, SEMS dysfunction, including occlusion and migration, occurs at a certain frequency in the long term, and appropriate reintervention is necessary to preserve the quality of life of the patient. Here, we present tips for endoscopic transpapillary SEMS placement for distal malignant biliary obstruction and reintervention for SEMS dysfunction. [ABSTRACT FROM AUTHOR]

Objectives: Selection criteria for self-expandable metal stents (SEMSs) with or without cover during palliative treatment of distal malignant biliary obstruction (DMBO) remain unclear. We evaluated factors associated with time to recurrent biliary obstruction (TRBO) in fully covered SEMSs (FCSEMSs) and uncovered SEMSs (UCSEMSs)., Methods: We retrospectively analyzed consecutive patients with DMBO who received a SEMS. TRBO was determined using the Kaplan-Meier analysis, and complications were compared between the FCSEMS and UCSEMS groups. After TRBO-associated factors were extracted using multivariate competing-risks regression (CRR), propensity score-adjusted CRRs were performed to verify their robustness., Results: There were 180 patients (66 FCSEMSs and 114 UCSEMSs) enrolled in this study. There was no significant difference between median TRBO in the FCSEMS and UCSEMS groups (275 vs. 255 days, p = 0.67). Complications were more frequent in the FCSEMS than UCSEMS group (21.2% vs. 8.8%; p = 0.023). Multivariate CRR for TRBO-associated factors revealed that "pancreatic ductal carcinoma (PDAC) treated with UCSEMS" was the only independent predictor of TRBO ( p = 0.03). Similarly, the propensity score-adjusted CRRs showed no significant difference in TRBO in "FCSEMS" vs "UCSEMS" ( p = 0.96); however, there was a significant difference in "PDAC using UCSEMS" vs "other" ( p = 0.043). In the palliative care group including any DMBO without chemotherapy, the first quartile of the TRBO of UCSEMS was 100 days., Conclusions: UCSEMSs are a possible option for both patients with DMBO arising from PDAC and for patients with any DMBO receiving palliative care who should avoid SEMS-related complications., Competing Interests: The author Kazuki Sumiyama is DEIC of DEN Open. The rest of the authors declare that they have no conflict of interest., (© 2022 The Authors. DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.)

Endoscopic biliary drainage with biliary stent placement is the treatment of choice for palliation in patients with malignant biliary obstruction caused by unresectable neoplasms. Various biliary stent designs have become available, but lack of a clear consensus persists on the use of covered versus uncovered metal stents in malignant distal bile duct obstructions, and plastic versus metal stents. In 2012, the European Society of Gastrointestinal Endoscopy indicated guidelines for biliary stenting. Accordingly, the consensus meeting for biliary stenting was held at the Endoscopic Forum Japan 2012, and four selected statements related to stent placement for distal malignant biliary obstruction were discussed to produce a consensus. Two of fourstatements (related to the usefulness of self-expandable metallic stents, and reintervention after stenting) were agreed upon by almost all participants. Nevertheless, our opinions were divided on the other two statements (necessity of sphincterotomy for stenting, and covered metal stent versus uncovered metal stent). We herein report the results of the meeting, and present proposed new statements via discussion. [ABSTRACT FROM AUTHOR]

Background: Although the combination of biliary and duodenal self-expandable metal stents (SEMS) is useful, the exacerbating effect of duodenal SEMS placement on biliary SEMS has not been documented. We conducted a multicenter retrospective study to evaluate the effect of duodenal SEMS placement on biliary SEMS. Methods: Patients who underwent first-time biliary SEMS placement for a distal malignant biliary obstruction between September 1994 and November 2010 were included. Time to dysfunction of biliary SEMS was analyzed to identify risk factors for biliary SEMS dysfunction. Duodenal SEMS placement was analyzed as a time-dependent covariate. Results: In total, 410 eligible patients were identified. Duodenal SEMS were placed in 33 patients (8 %). The median time to dysfunction of biliary SEMS was 170 days. Male gender (hazard ratio 1.37, 95 % confidence interval 1.03-1.83, P = 0.029) and duodenal SEMS placement (hazard ratio 2.00, 95 % confidence interval 1.16-3.45, P = 0.013) were risk factors in the multivariate Cox model. In patients undergoing duodenal SEMS, biliary SEMS dysfunction was observed in 17 (52 %) with a median time to dysfunction of 64 days after duodenal SEMS placement. As many as 60 % of the patients with biliary SEMS dysfunction after duodenal SEMS placement needed permanent percutaneous transhepatic biliary external drainage. Conclusions: Duodenal SEMS placement is a risk factor for biliary SEMS dysfunction. Alternative methods for biliary drainage should be considered for better biliary drainage in patients with a gastric outlet obstruction. [ABSTRACT FROM AUTHOR]

Background and Aim Pancreatitis and cholecystitis are major complications after self-expandable metal stent ( SEMS) placement in distal malignant biliary obstruction. We aimed to clarify predictive factors for pancreatitis and cholecystitis after covered SEMS placement. Methods We retrospectively reviewed 74 consecutive patients with distal malignant biliary obstruction who underwent initial endoscopic drainage using covered SEMS. Predictive factors for pancreatitis and cholecystitis were evaluated in the 74 patients described above and in 66 patients who had not undergone cholecystectomy. Results The incidences of pancreatitis and cholecystitis were 10.8% (8/74) and 6.1% (4/66), respectively. Univariate analysis revealed that non-pancreatic cancer ( P = 0.018) and contrast injection into the pancreatic duct ( P = 0.030) were significant predictive factors for pancreatitis. Multivariate analysis revealed that non-pancreatic cancer (odds ratio [ OR], 4.21; 95% confidence interval [ CI], 1.63-14.18; P = 0.007) and contrast injection into the pancreatic duct ( OR, 3.34; 95% CI, 1.33-9.60; P = 0.016) were significant independent predictive factors for pancreatitis. On the other hand, univariate and multivariate analyses revealed that tumor involvement to the orifice of the cystic duct ( OCD) was a significant independent predictive factor for cholecystitis ( OR, 5.85; 95% CI, 1.91-27.74; P = 0.005). Conclusions Non-pancreatic cancer and contrast injection into the pancreatic duct were predictive factors for pancreatitis, and tumor involvement to the OCD was a positive predictive factor for cholecystitis after endoscopic covered SEMS placement for distal malignant biliary obstruction. [ABSTRACT FROM AUTHOR]

Background: Although self-expandable metal stents (SEMS) are widely used for distal malignant biliary obstruction, one-step SEMS (direct placement without a prior plastic stent) and two-step SEMS (placement at second endoscopic retrograde cholangiopancreatography [ERCP] following plastic stent placement) have not been fully compared. Methods: In this multicenter retrospective study, patients were included who underwent first-time endoscopic SEMS placement between September 1994 and December 2010. We compared the one-step and two-step strategies using a propensity analysis. Results: In total, 370 patients were identified and one-step SEMS was performed in 59 patients. After adjustment using propensity scores, the median times to dysfunction were 116 and 219 days, respectively, for one-step and two-step SEMS ( P = 0.058). Stent migration was more frequently observed in one-step SEMS as compared with two-step SEMS (25 vs. 11 %, P = 0.031). In one-step SEMS, the number of days of hospitalization associated with first-time SEMS placement was shorter compared with that in two-step SEMS (21 vs. 30 days, P = 0.001), and the total costs of SEMS-related interventions within 6 months were lower (6510 and 8100 USD, P = 0.004). The pathological diagnosis rates for pancreatic and biliary tract cancer at initial ERCP were 52 and 61 %. After failed diagnosis at initial ERCP, pathological diagnosis rates for pancreatic cancer were 32 versus 76 % ( P = 0.005) by repeated ERCP versus endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA). Conclusions: One-step SEMS was associated with increased stent migration, despite having potential cost-effectiveness. The additional yield of pathological diagnosis at repeated ERCP was low compared with that yielded by EUS-guided FNA. [ABSTRACT FROM AUTHOR]

Distal malignant biliary obstruction is caused by various malignant diseases that require biliary drainage. In patients with operable situations, preoperative biliary drainage is required to control jaundice and cholangitis until surgery. In view of tract seeding, endoscopic biliary drainage is the first choice. Since neoadjuvant therapies are being developed, the time to surgery is increasing, especially in pancreatic cancer cases. Therefore, it requires long stent patency. Recently, preoperative biliary drainage using self-expandable metal stents has been reported as a useful modality to secure long stent patency. In patients with unresectable distal malignant biliary obstruction, self-expandable metal stent is the first choice for maintaining long stent patency. Although there are many comparison studies between a covered and an uncovered self-expandable metal stent, their use is still controversial. Recently, endoscopic ultrasound-guided biliary drainage has been performed as an alternative treatment. The clinical success and stent patency are favorable. We should take into consideration that both endoscopic retrograde cholangiopancreatography-guided biliary drainage and endoscopic ultrasound-guided biliary drainage have advantages and disadvantages and chose the drainage method depending on the patient's situation or the expertise of the endoscopist. Here, we discuss the current status of endoscopic biliary drainage in patients with distal malignant biliary obstruction. [ABSTRACT FROM AUTHOR]

Background: Endoscopic biliary stenting is a well-established palliative treatment for patients with unresectable distal malignant biliary obstruction (MBO). However, the main problem with stent placement is the relatively short duration of stent patency. Although self-expanding metal stents (SEMSs) have a longer patency period than plastic stents (PSs), the higher costs limit the wide use of SEMSs. A PS with an antireflux valve is an attractive idea to prolong stent patency, but no ideal design for an antireflux PS (ARPS) has been proposed. We developed a new ARPS with a "duckbilled" valve attached to the duodenal end of the stent., Aim: To compare the patency of ARPSs with that of traditional PSs (TPSs) in patients with unresectable distal MBO., Methods: We conducted a single-center, prospective, randomized, controlled, double-blind study. This study was conducted at the West China Hospital of Sichuan University. Consecutive patients with extrahepatic MBO were enrolled prospectively. Eligible patients were randomly assigned to receive either an ARPS or a TPS. Patients were followed by clinic visits or telephone interviews every 1-2 mo until stent exchange, death, or the final study follow-up in October 2018. The primary outcome was the duration of stent patency. Secondary outcomes included the rate of technical success, the rate of clinical success, adverse events, and patient survival., Results: Between February 2016 and December 2017, 38 patients were randomly assigned to two groups, with 19 patients in each group, to receive ARPSs or TPSs. Stent insertion was technically successful in all patients. There were no significant differences between the two groups in the rates of clinical success or the rates of early or late adverse events ( P = 0.660, 1.000, and 1.000, respectively). The median duration of stent patency in the ARPS group was 285 d [interquartile range (IQR), 170], which was significantly longer than that in the TPS group (median, 130 d; IQR, 90, P = 0.005). No significant difference in patient survival was noted between the two groups ( P = 0.900)., Conclusion: The new ARPS is safe and effective for the palliation of unresectable distal MBO, and has a significantly longer stent patency than a TPS., Competing Interests: Conflict-of-interest statement: Professor Bing Hu is one of the inventors of the antireflux plastic stent. He has worked in collaboration with Micro-Tech (Nanjing) Co. Ltd., Nanjing, China to develop the stent. No free device was offered for this study. The authors disclose no conflicts of interest.

Background: We aimed to clarify the clinical usefulness of one-step self-expandable metal stent (SEMS) placement for distal malignant biliary obstruction by comparing with two-step SEMS placement., Methods: We retrospectively compared early complications, bilirubin level decreasing rate, and period of hospitalization between 40 patients with one-step SEMS and 52 patients with two-step SEMS. We also evaluated the complications in patients with two-step SEMS by classifying them into first drainage (ERBD or ENBD) and second drainage (SEMS)., Results: The total incidence of early complications was significantly higher in patients with one-step SEMS than the second drainage of two-step SEMS (42.5% [17/40] vs. 13.5% [7/52]; P = 0.004). However, there was no significant difference in the early complications between one-step SEMS and two-step SEMS (total of first and second drainage) (42.5% [17/40] vs. 36.5% [19/52]; P = 0.561). The period required to reach the bilirubin level (<3 mg/dL) after initial drainage was significantly shorter in one-step SEMS than in two-step SEMS (5.7 vs. 10.1 days; P = 0.025). Similar results were observed in the period of hospitalization for patients without chemotherapy (22.2 vs. 37.3 days; P = 0.004)., Conclusions: One-step SEMS placement is the alternative option of drainage method for distal malignant biliary obstruction., (© 2013 Japanese Society of Hepato-Biliary-Pancreatic Surgery.)