Inside stent placement is suitable for preoperative biliary drainage in patients with perihilar cholangiocarcinoma.

BACKGROUND/PURPOSE: Endoscopic biliary stenting (EBS) is commonly used for preoperative drainage of localized perihilar cholangiocarcinoma (LPHC). This study retrospectively compared the utility of inside stent (IS) and conventional stent (CS) for preoperative EBS in patients with LPHC. METHODS: EBS was performed in 56 patients with LPHC. EBS involved the placement of a CS (n = 32) or IS (n = 24). Treatment outcomes were compared between these two groups. RESULTS: Preoperative recurrent biliary obstruction (RBO) occurred in 23 patients (71.9%) in the CS group and 7 (29.2%) in the IS group, with a significant difference (p = 0.002). The time to RBO (TRBO) was significantly longer in IS than in CS (log-rank: p < 0.001). The number of stent replacements was significantly lower in IS than CS [0.38 (0-3) vs. 1.88 (0-8), respectively; p < 0.001]. Gemcitabine-based neoadjuvant chemotherapy (NAC) was administered to 26 patients (46.4%). Among patients who received NAC, TRBO was longer in IS than in CS group (log-rank: p < 0.001). The IS group had a significantly shorter preoperative and postoperative hospital stay than the CS group (20.0 vs. 37.0 days; p = 0.024, and 33.5 vs. 41.5 days; p = 0.016).　 Both the preoperative and the postoperative costs were significantly lower in the IS group than in the CS group (p = 0.049 and p = 0.0034, respectively). CONCLUSION: Compared with CS, IS for preoperative EBS in LPHC patients resulted in fewer complications and lower re-intervention rates. The fact that the IS group had shorter preoperative and postoperative hospital stays and lower costs both preoperatively and postoperatively compared to the CS group may suggest that the use of IS has the potential to benefit not only the patient but also the healthcare system.

Impact of sarcopenia on recurrent biliary obstruction after EUS-guided biliary drainage in patients with malignant biliary obstruction.

BACKGROUND AND AIMS: Sarcopenia is an important prognostic factor for cancer patients. The aim of this study was to assess the ability of sarcopenia to predict recurrent biliary obstruction (RBO) in patients with unresectable cancer after EUS-guided biliary drainage (EUS-BD). METHODS: The study enrolled 113 patients who underwent EUS-BD using the self-expandable metal stent (SEMS) for unresectable malignant biliary obstruction (MBO) between April 2016 and December 2021 at Wakayama Medical University Hospital. The skeletal muscle index at the third lumbar spine level (L3) was calculated from computed tomography images. We analyzed the cumulative incidence of RBO at 180 days after stent insertion. Univariate and multivariate analyses were performed to identify variables significantly associated with RBO. RESULTS: Seventy-six patients were assigned to the sarcopenia group, and 37 were assigned to the non-sarcopenia group. The 180-day cumulative incidence of RBO was 11% in the non-sarcopenia group and 29% in the sarcopenia group (p = 0.034). The time to RBO was significantly shorter for the sarcopenia group (p = 0.028; Gray's test). Multivariate analyses identified sarcopenia as an independent prognostic factor for RBO (present vs absent; HR 4.61; 95% CI 1.76-12.10, p = 0.001). The rates of biliary sludge/food impaction were significantly higher in the sarcopenia group for the causes of RBO (p = 0.048). There were no significant differences between the sarcopenia and the non-sarcopenia groups with respect to related EUS-BD adverse events. CONCLUSION: Sarcopenia is an independent indicator of RBO in patients with MBO who receive EUS-BD with SEMS.

Long-term outcomes of duckbill-type anti-reflux metal stents versus conventional covered metal stents in reinterventions after covered biliary metal stent dysfunction in unresectable 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.

Comparable Efficacy of Laser-Cut and Braided Self Expanding Metallic Biliary Stent: A Systematic Review and Meta-Analysis.

BACKGROUND AND AIMS: In patients with unresectable malignant biliary obstruction (MBO), endoscopic biliary drainage is the treatment of choice. Self-expanding metallic stents (SEMS) are mainly used for this purpose, and data is limited on the comparative outcomes of laser-cut versus braided SEMS. Herein, we performed the first systematic review and meta-analysis to study the effectiveness and safety of braided and laser-cut SEMS in MBO. METHODS: Multiple databases, including Medline, Scopus, and Embase, were searched (in May 2022) using specific terms for studies evaluating the outcomes of braided and laser-cut SEMS in MBO. Outcomes of interest were technical and clinical success, recurrent biliary obstruction, and adverse events. Standard meta-analysis methods were employed using the random-effects model. I2% heterogeneity was used to assess the heterogeneity. RESULTS: Seven studies were included in the final analysis. (Laser-cut: 271 patients, 46% females, mean age 70 years; and braided: 282 patients, 47% females, mean age 72 years). The pooled rate of technical success and clinical success with laser-cut SEMS was 99% (95% CI [95-99; I2 = 0%]), 86% [60-96; I2 = 74%], and 98% [96-99; I2 = 0%], 89% [74-95; I2 = 78%] with braided. The pooled rate of recurrent biliary obstruction with laser-cut SEMS was 26% [14-43; I2 = 88%] and 12% [5-27; I2 = 56%) with braided. Pooled total adverse events were 11% [5-21; I2 = 77%] in laser-cut and 12% [6-24; I2 = 63%] in braided. CONCLUSION: Our meta-analysis demonstrates similar clinical outcomes with laser-cut and braided SEMS in MBO. Given the comparable performance, a cost-effectiveness analysis might help in choosing one type versus another in patients with MBO.

Endoscopic re-intervention after stent-in-stent versus side-by-side bilateral self-expandable metallic stent deployment.

BACKGROUND AND AIM: Endoscopic bilateral self-expandable metallic stent (SEMS) placement for unresectable malignant hilar biliary obstruction (MHBO) is widely performed; however, re-intervention after recurrent biliary obstruction (RBO) is often challenging. We compared stent-in-stent (SIS) and side-by-side (SBS) SEMS placement for MHBO considering re-intervention for RBO. METHODS: One hundred five consecutive patients with MHBO who underwent endoscopic bilateral SEMS placement in our hospital and its affiliated institutions were enrolled in this study; 75 patients underwent partial SIS deployment between December 2005 and December 2012; and 30 underwent SBS deployment between January 2013 and March 2019. Initial treatments and re-interventions in each group were retrospectively evaluated. RESULTS: Technical success rate (92% vs 100%, P = 0.179), procedure duration (46 vs 35 min, P = 0.382), functional success rate (97.1% vs 100%, P = 1.00), complication rate (24.6% vs 20.0%, P = 0.797), time to RBO (260 vs 312 days; Gray test, P = 0.815), and rate of RBO (59.4% vs 70.0%, P = 0.371) were not significantly different between the SIS and SBS groups. However, bilateral re-stenting with plastic stents through SEMS was successful in 63.4% of patients in the SIS group compared with 100% of patients in the SBS group (P = 0.0013). Median time to RBO upon first re-stenting with a plastic stent was 75 days (range, 11-195 days). CONCLUSIONS: Endoscopic re-stenting after RBO was significantly more successful in the SBS group than in the SIS group. SBS method is suitable for MHBO considering revisionary stent placement.

Comparison of outcomes between secondary fully covered and uncovered self-expandable metal stents in the treatment of recurrent biliary obstruction of pancreatic cancer.

BACKGROUND: The overall survival (OS) of pancreatic cancer (PC) has been prolonged by advances in chemotherapy, and the number of cases of recurrent biliary obstruction (RBO) after self-expandable metal stent (SEMS) placement is expected to increase. We herein compared outcomes between secondary fully covered SEMS (FC) and uncovered SEMS (UC) for RBO of PC with FC placed as the 1st SEMS. METHODS: Between May 2010 and March 2021, 62 PC patients who underwent SEMS exchange to FC (n = 34) or UC (n = 28) for RBO were retrospectively analyzed. Patient characteristics, OS, time to RBO (TRBO), and stent-related adverse events were compared between the FC and UC groups. Cox's proportional hazard model was used to identify risk factors for RBO with the 2nd SEMS. RESULTS: There was a significant difference between the FC and UC groups only in the 2nd SEMS diameter. Median OS and TRBO were 195 and 238 days in FC patients and 306 and 455 days in UC patients, respectively, with no significant differences between the two groups. No significant differences were observed in the stent-related adverse event rate. In multivariate analyses, only the 2nd SEMS diameter was significant (P = 0.009). Median TRBO were 455, 238, and 103 days in 10-mm UC, 10-mm FC, and 8-mm UC patients, with 10-mm UC patients having significantly longer TRBO than 10-mm FC and 8-mm UC patients (P = 0.020 and 0.001). CONCLUSION: SEMS exchange to 10-mm UC may be appropriate for RBO of PC with FC as the 1st SEMS.

Hepatic Cyst Infection Following Recurrent Biliary Obstruction in Polycystic Liver Disease.

An 89-year-old man with polycystic liver disease (PCLD) received uncovered self-expandable metallic stent (SEMS) placement above the papilla for malignant biliary obstruction caused by cholangiocarcinoma. He developed cholangitis ten months later due to SEMS occlusion caused by tumor ingrowth, and 2 plastic biliary stents were placed inside the SEMS across the papilla. Fever and right costal pain appeared two weeks after reintervention. Suspecting hepatic cyst infection based on imaging studies, percutaneous transhepatic cyst drainage was performed. Increased inflammatory cells and the presence of pathogens in the cyst fluid led to a definitive diagnosis of hepatic cyst infection. Following drainage, the hepatic cyst shrank with resolution of the symptoms. SEMS occlusive-related cholangitis or retrograde infection due to duodenal-biliary reflux after reintervention was considered as the cause of the hepatic cyst infection. Careful clinical and imaging evaluation should be performed in patients with PCLD undergone biliary stenting, because cyst infection may occur following stent occlusion or subsequent biliary reintervention.

Recurrence of biliary tract obstructions after primary laparoscopic hepaticojejunostomy in children with choledochal cysts.

BACKGROUND: The aim of the current study was to investigate the cause and develop a management strategy for recurrent biliary obstructions after primary laparoscopic hepaticojejunostomy in children with choledochal cyst (CDC). METHODS: Thirty CDC patients (mean age: 7.15 years, range 8 months-24 years, F/M: 22/8) who suffered from recurrent biliary obstructions after primary laparoscopic hepaticojejunostomies were referred to our hospital between January 2006 and June 2014. All patients underwent redo hepaticojejunostomy ± ductoplasty ± reposition of aberrant right hepatic arteries. RESULTS: All patients developed recurrent cholangitis or persistent abnormal liver function 1 month to 7 years postoperatively. Liver biopsy pathology verified that 56.7 % (17/30) of patients had grades I-IV of liver fibrosis. We identified a previously unreported cause of biliary obstruction, i.e., aberrant right hepatic arteries crossing anteriorly to the proximal common hepatic duct in high percentage of the patients who suffered from postoperative recurrent biliary obstructions (7/30, 23.3 %). The hepatic arteries were repositioned behind Roux loop during the redo hepaticojejunostomies. Of remaining patients, nine (30 %) patients had associated hepatic duct strictures and underwent ductoplasties and wide hepaticojejunostomies. Fourteen (46.7 %) patients had anastomotic strictures and underwent redo hepaticojejunostomies. The median follow-up period was 62 months (14-115 months). No recurrent biliary obstruction or cholangitis was observed up to date. Liver functions were normalized. CONCLUSIONS: Aberrant hepatic artery, unsolved hepatic duct stricture, as well as poor anastomotic technique, can all contribute to recurrent biliary obstructions after the primary laparoscopic hepaticojejunostomies. Early surgical correction is advocated to minimize liver damage.

Reintervention for stent occlusion after bilateral self-expandable metallic stent placement for malignant hilar biliary obstruction.

BACKGROUND AND AIM: Endoscopic reintervention for stent occlusions following bilateral self-expandable metallic stent (SEMS) placement for malignant hilar biliary obstruction (MHBO) is challenging, and time to recurrent biliary obstruction (RBO) of the revisionary stent remains unclear. We aimed to clarify a suitable reintervention method for stent occlusions following bilateral SEMS placement for MHBO. METHODS: Between 2002 and 2014, 52 consecutive patients with MHBO who underwent endoscopic reintervention for stent occlusion after bilateral SEMS placement were enrolled at two university hospitals and one tertiary care referral center. We retrospectively evaluated the technical and functional success rates of the reinterventions, and the time to RBO of the revisionary stents. RESULTS: Technical and functional success rates of the reinterventions were 92% (48/52) and 90% (43/48), respectively. Univariate analysis did not determine any significant predictive factors for technical and functional failures. Median time to RBO of the revisionary stents was 68 days. Median time to RBO was significantly longer for revisionary SEMS placement than for plastic stent placement (131 days vs 47 days, respectively; log-rank test, P = 0.005). Revisionary SEMS placement was the only independent factor that was significantly associated with a longer time to RBO of the revisionary stent in the multivariate Cox proportional hazards analysis (hazard ratio 0.37; 95% confidence interval 0.14-0.95; P = 0.039). CONCLUSION: Revisionary SEMS placement is a suitable endoscopic reintervention method for stent occlusion following bilateral SEMS placement from the perspective of time to RBO of the revisionary stent.

Impact of sarcopenia on biliary drainage during neoadjuvant therapy for pancreatic cancer.

BACKGROUND/AIMS: Since the usefulness of neoadjuvant chemo(radiation) therapy (NAT) for pancreatic cancer has been demonstrated, recurrent biliary obstruction (RBO) in patients with pancreatic cancer with a fully covered self-expandable metal stent (FCSEMS) during NAT is expected to increase. This study investigated the impact of sarcopenia on RBO in this setting. METHODS: Patients were divided into normal and low skeletal muscle index (SMI) groups and retrospectively analyzed. Patient characteristics, overall survival, time to RBO (TRBO), stent-related adverse events, and postoperative complications were compared between the two groups. A Cox proportional hazard model was used to identify the risk factors for short TRBO. RESULTS: A few significant differences were observed in patient characteristics, overall survival, stent-related adverse events, and postoperative complications between 38 patients in the normal SMI group and 17 in the low SMI group. The median TRBO was not reached in the normal SMI group and was 112 days in the low SMI group (p=0.004). In multivariate analysis, low SMI was the only risk factor for short TRBO, with a hazard ratio of 5.707 (95% confidence interval, 1.148-28.381; p=0.033). CONCLUSION: Sarcopenia was identified as an independent risk factor for RBO in patients with pancreatic cancer with FCSEMS during NAT.

Risk factors for recurrent biliary obstruction following suprapapillary placement of a plastic stent as preoperative biliary drainage for perihilar biliary malignancy.

BACKGROUND/PURPOSE: The usefulness of endoscopic biliary stenting by deploying a plastic stent suprapapillary, called inside-stent (IS) placement, as preoperative biliary drainage (PBD) for perihilar biliary malignancy (PHBM) has been demonstrated. This study investigated risk factors for recurrent biliary obstruction (RBO) after IS placement. METHODS: Consecutive patients with potentially resectable PHBM treated with IS placement as PBD between 2017 and 2023 at Nagoya University Hospital were retrospectively reviewed. RESULTS: A total of 157 patients were included, with RBO occurring in 34 (22%) patients. The non-RBO rates were 83% at 30 days, 77% at 60 days, and 57% at 90 days. The most common cause of RBO was stent occlusion (n = 14), followed by segmental cholangitis (n = 12) and stent migration (n = 8). Stent migration and occlusion occurred more frequently within and after 1 week post-stenting, respectively. In multivariate analysis, biliary infection before IS was the sole risk factor for RBO, with a hazard ratio of 2.404 (95% confidence interval 1.163-4.972; p = .018). This risk was reduced by temporary endoscopic nasobiliary drainage prior to definitive IS placement. CONCLUSIONS: Biliary infection before IS was identified as an independent risk factor for RBO in patients with PHBM with IS as PBD. CLINICAL TRIAL REGISTER: Clinical trial registration number: UMIN000025631.

Risk factors for recurrent biliary obstruction following endoscopic biliary stenting in patients with unresectable ampullary cancer: A multicenter retrospective study.

OBJECTIVES: Unresectable ampullary cancer (AC) is a rare disease entity. The risk factors for recurrent biliary obstruction (RBO) following endoscopic biliary stenting (EBS) for unresectable AC remain unknown. In this study we aimed to evaluate the cumulative RBO rate and to identify risk factors for RBO following palliative EBS in patients with unresectable AC. METHODS: This multicenter retrospective observational study enrolled consecutive patients with unresectable AC who had undergone palliative EBS between April 2011 and December 2021. The cumulative rate of and risk factors for RBO following palliative EBS were evaluated via multivariate analysis. RESULTS: The study analysis comprised 107 patients with a median age of 84 years (interquartile range 79-88 years). Plastic stents (PSs) and self-expandable metal stents (SEMSs) were placed in 53 and 54 patients, respectively. Functional success was accomplished in 104 (97.2%) patients. Of these, RBO occurred in 62 (59.6%) patients, with obstruction and complete/partial migration occurring in 47 and 15 patients, respectively. The median time to RBO was 190 days. Multivariate analysis showed that PS was associated with a higher rate of RBO compared to SEMS (hazard ratio [HR] 2.48; P < 0.01) and that the presence of common bile duct stones/sludge immediately after EBS was an independent risk factor for RBO (HR 1.99; P = 0.04). CONCLUSIONS: The use of SEMS compared to PS during EBS reduced the time to RBO in patients with unresectable AC. Common bile duct stones/sludge immediately after EBS was a risk factor for RBO.

Comparison of the utility of covered metal stents versus uncovered metal stents in the management of malignant biliary strictures in 749 patients.

BACKGROUND: Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstruction. OBJECTIVE: To compare outcomes between covered self-expandable metal stents (CSEMSs) and uncovered self-expandable metal stents (USEMSs) in malignant biliary obstruction. DESIGN: Retrospective cohort study. SETTING: Tertiary cancer center. PATIENTS: Patients with malignant biliary obstruction. INTERVENTIONS: Placement of CSEMS or USEMS. MAIN OUTCOME MEASUREMENTS: Time to recurrent biliary obstruction (TRO), overall survival (OS), and adverse events. RESULTS: From January 2000 to June 2011, 749 patients received SEMSs: 171 CSEMSs and 578 USEMSs. At 1 year, there was no significant difference in the percentage of patients with recurrent obstruction (CSEMSs, 35% vs USEMSs, 38%) and survival (CSEMSs, 45% vs USEMSs, 49%). There was no significant difference in the median OS (CSEMSs, 10.4 months vs USEMSs, 11.8 months; P = .84) and the median TRO (CSEMSs, 15.4 months vs USEMSs, 26.3 months; P = .61). The adverse event rate was 27.5% for the CSEMS group and 27.7% for the USEMS group. Although tumor ingrowth with recurrent obstruction was more common in the USEMS group (76% vs 9%, P < .001), stent migration (36% vs 2%, P < .001) and acute pancreatitis (6% vs 1%, P < .001) were more common in the CSEMS group. LIMITATIONS: Retrospective study. CONCLUSIONS: There was no significant difference in the patency rate or overall survival between CSEMSs and USEMSs for malignant distal biliary strictures. The CSEMS group had a significantly higher rate of migration and pancreatitis than the USEMS group. No significant SEMS-related adverse events were observed in patients undergoing neoadjuvant chemoradiation or surgical resection.

Re-intervention with 10-mm vs 12-mm covered self-expandable metallic stent for recurrent unresectable distal biliary obstruction in patients with previous stent implantation.

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.

Efficacy of Fully Covered Self-Expandable Metal Stents for Distal Biliary Obstruction Caused by Pancreatic Ductal Adenocarcinoma: Primary Metal Stent vs. Metal Stent following Plastic Stent.

Fully covered self-expandable metallic stents (FCSEMSs) are inserted in patients with unresectable pancreatic ductal adenocarcinoma (PDAC) to resolve malignant distal bile duct obstructions. Some patients receive FCSEMSs during primary endoscopic retrograde cholangiopancreatography (ERCP), and others receive FCSEMSs during a later session, after the placement of a plastic stent. We aimed to evaluate the efficacy of FCSEMSs for primary use or following plastic stent placement. A total of 159 patients with pancreatic adenocarcinoma (m:f, 102:57) who had achieved clinical success underwent ERCP with the placement of FCSEMSs for palliation of obstructive jaundice. One-hundred and three patients had received FCSEMSs in a first ERCP, and 56 had received FCSEMSs after prior plastic stenting. Twenty-two patients in the primary metal stent group and 18 in the prior plastic stent group had recurrent biliary obstruction (RBO). The RBO rates and self-expandable metal stent patency duration did not differ between the two groups. An FCSEMS longer than 6 cm was identified as a risk factor for RBO in patients with PDAC. Thus, choosing an appropriate FCSEMS length is an important factor in preventing FCSEMS dysfunction in patients with PDAC with malignant distal bile-duct obstruction.

Comparison of recurrent biliary obstruction with the use of metal and plastic stents in EUS-guided biliary drainage: A propensity score-matched analysis.

Background and Objectives: In transpapillary biliary drainage, metal stents (MSs) exhibit a lower incidence of a biliary obstruction than plastic stents (PSs). However, few studies have compared recurrent biliary obstruction (RBO) when MSs and PSs are used in EUS-guided hepaticogastrostomy (EUS-HGS) and choledochoduodenostomy (EUS-CDS). We retrospectively evaluated the RBO for both stents in each procedure. Patients and Methods: : Between November 2012 and December 2020, 85 and 53 patients who underwent EUS-HGS and EUS-CDS for unresectable malignant biliary obstruction, respectively, were enrolled. Factors associated with RBO were assessed. Clinical outcomes were compared between the MS and PS groups using propensity score matching. Results: : The clinical success rate and procedure-related adverse events were similar in the MS and PS groups. Multivariate analysis identified the use of PS as a factor associated with RBO (EUS-HGS, P = 0.03; EUS-CDS, P = 0.02). After matching, the median time to RBO in EUS-HGS (MS: 313; PS: 125 days; P = 0.01) in the MS group was longer than that in the PS group. The cumulative incidence of RBO at 1, 3, and 6 months in the MS group was significantly lower than that in the PS group for EUS-HGS (MS: 4.0%, 8.2%, and 8.2%; PS: 12.4%, 24.9%, and 39.5%, respectively, P = 0.01). Conclusions: : MS exhibited a lower rate of RBO than PS for EUS-HGS and EUS-CDS.

Efficacy and safety of a novel anti-reflux metal stent during neoadjuvant chemotherapy for pancreatic cancer: A prospective multicenter exploratory study.

BACKGROUND/PURPOSE: The benefits of anti-reflux metal stents, used for treating biliary obstruction in patients receiving neoadjuvant chemotherapy (NAC) for pancreatic cancer, are yet unknown. Herein, the safety and efficacy of the novel duckbill-type anti-reflux metal stent (D-ARMS) were prospectively evaluated for biliary drainage. Additionally, the incidence of recurrent biliary obstruction (RBO) after placement of D-ARMS vs conventional covered self-expandable metal stents (CCSEMSs) was retrospectively compared. METHODS: Patients who received D-ARMS (n = 33) for treatment of distal biliary obstruction before NAC between September 2019 and January 2021 and those that received CCSEMSs (n = 38) between January 2013 and August 2019 were included in the historical control group. Technical and clinical successes, rate of RBO, and cumulative incidence of RBO were compared between the two groups. RESULTS: The technical success rate was 100% for both the D-ARMS and CCSEMS groups, and the clinical success rate were not significantly different (93.9% and 89.5%, respectively; P = .68). In the multivariate analysis, D-ARMS was identified as the independent factor for cumulative incidence of RBO (P = .03). The cumulative incidence of RBO was significantly lower in the D-ARMS group than that in the CCSEMS group (P = .04). CONCLUSIONS: D-ARMS is safe and effective for patients receiving NAC.

The efficacy and safety of a duckbill-type anti-reflux metal stent as the initial metal stent for distal malignant biliary obstruction in unresectable pancreatic cancer.

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.

Comparison of unilateral and bilateral intraductal plastic stent placement for unresectable malignant hilar biliary obstruction: A propensity score-matched cohort analysis.

BACKGROUND: Although intraductal plastic stent (IS) placement is an effective treatment for unresectable malignant hilar biliary obstruction (UMHBO), the effectiveness of unilateral and bilateral IS drainage remains controversial. This retrospective study investigated the effectiveness of bilateral IS placement for UMHBO using the propensity score matching method. METHODS: Patients who underwent transpapillary endoscopic stenting for UMHBO were analyzed for technical and clinical success, adverse events, and time to recurrent biliary obstruction (TRBO). RESULTS: A total of 321 patients were enrolled in the study with 27 patients in each unilateral and bilateral IS group in the propensity score-based cohort. Technical success was 100%, while clinical success was 93% and 96% in the unilateral and bilateral IS groups, respectively (p = 1.0). Cholecystitis occurred in 4% and 7%, respectively (p = 1.0). The median TRBO was shorter in the unilateral group (129 [5-383] days) than that in the bilateral group (226 [16-563] days) (p = .0281). Bilateral IS placement was an independent long TRBO factor (hazard ratio [HR] 0.46; 95% confidence interval [CI]: 0.21-0.97; p = .041). CONCLUSIONS: Unilateral and bilateral IS placement had high technical and clinical success rates in primary stent placement. However, bilateral IS placement showed a longer TRBO. Bilateral IS placement may be a good option for initial UMHBO drainage.

Potential significance of uncovered self-expandable metal stents for distal malignant biliary obstruction: A propensity score-adjusted competing risk regression analysis.

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.