Unresectable Distal Malignant Biliary Obstruction Research Articles

Secondary uncovered versus fully-covered metal stents for the management of occluded stent in unresectable distal malignant biliary obstruction

IntroductionSelf-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 methodsBetween 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. ResultsTechnical (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. ConclusionsThe 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.

Potential of 6-mm-diameter fully covered self-expandable metal stents for unresectable malignant distal biliary obstruction: a propensity score-matched study

Potential of 6-mm-diameter fully covered self-expandable metal stents for unresectable malignant distal biliary obstruction: a propensity score-matched study

Covered Versus Uncovered Metal Stents for the Drainage of the Malignant Distal Biliary Obstruction With ERCP: A Systematic Review and Meta-Analysis.

Unresectable malignant distal biliary obstruction is a condition that should be treated with drainage and clearance of the biliary duct. self-expanded metal stents (SEMS) are known to be better and more effective than plastic stents because the patency is longer. The actual evidence is insufficient to recommend if it is better the use of SEMSu over SEMSc or vice versa for the drainage of the malignant distal biliary obstruction during ERCP. We performed a systematic review and meta-analyses to demonstrate if exists superiority between one or other type of SEMS performed by ERCP. We conducted a systematic review in different databases, such as PubMed, Cochrane, Medline, and OVID database. A search was made of all studies published up to May 2023. Seven studies were analyzed. A total of 1070 patients were included. Of the total of patients, 48.9% were male. The cumulative stent patency, the failure rate, the survival probably and the adverse events rate, were similar between SEMSc and SEMSu groups. The stent migration rate was higher in the SEMSc group (RR=2.34 [95% CI: 1.35-4.08]). The tumor overgrowth was higher in the SEMSc group (RR=2.05 [95% CI: 1.13-3.72]). The tumor ingrowth was higher in the SEMSu group (RR=0.25 [95% CI: 0.11-0.61]). The conclusions of our study show that there are no differences between the use of uncovered SEMS and covered SEMS for palliative treatment of distal biliopancreatic obstructions, and it has no impact on mortality or patient survival. New functional studies regarding the type of stent cover, radial force or length thereof are required.

Endoscopic ultrasound-guided biliary drainage in failed endoscopic retrograde cholangiopancreatography: A case series and review of literature

Abstract Obstructive jaundice is a common clinical manifestation of malignant biliary obstruction (MBO). Pancreaticobiliary malignancy causes a significant proportion of distal biliary obstructions, most of which are unresectable at the time of diagnosis. Palliative biliary drainage is required in cases of unresectable malignant distal biliary obstruction (MDBO). Surgical, endoscopic, or percutaneous methods can relieve biliary obstruction. Percutaneous transhepatic biliary drainage (PTBD) is the most common alternative method if endoscopic retrograde cholangiopancreatography (ERCP) fails. The complication rate of PTBD and associated comorbidities is high. Endoscopic ultrasound-guided biliary drainage (EUS-BD) has two access routes, i.e., intrahepatic and extrahepatic. The technical and clinical success rate of EUS-BD is high, exceeding 90%. When ERCP fails, the EUS rendezvous approach should be attempted first if papilla is accessible. Transmural drainage is the preferred method if the papilla is inaccessible. For distal and mid-common bile duct obstruction, we perform EUS-guided choledochoduodenostomy (EUS-CDS). For EUS-CDS, one can use either a self-expandable metallic stent (SEMS) or a lumen-apposing metal stent. EUS-BD procedures are technically challenging, and adverse events are common even in expert hands. A multidisciplinary approach is most appropriate for patients with distal MBO who fail ERCP.

Secondary uncovered versus fully-covered metal stents for the management of occluded stent in unresectable distal malignant biliary obstruction

IntroductionSelf-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 methodsBetween 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. ResultsTechnical (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. ConclusionsThe 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.

Comparison between Endoscopic Ultrasound-Guided Antegrade and Transluminal Stent Implantation in Distal Malignant Biliary Obstruction after Failed ERCP.

Distal malignant biliary obstruction (DMBO) can result in obstructive jaundice. Endoscopic ultrasound- (EUS-) guided biliary drainage (EUS-BD) has been an alternative for DMBO after failed ERCP. To compare the efficacy and safety between antegrade and transluminal approaches in patients with unresectable DMBO when ERCP failed. Patients with DMBO leading to obstructive jaundice after failed ERCP were enrolled in this study. We retrospectively evaluated the safety and efficacy between EUS-guided transluminal stenting (TLS group) and antegrade stenting (AGS group). 82 patients were enrolled, of which 45 patients were in TLS group and 37 in AGS group. There were no statistical differences in the malignancy type, baseline common bile duct diameter, total bilirubin level, reason for EUS-BD, and history of biliary drainage between TLS and AGS groups. The technical success rate was statistically higher in TLS group than in AGS group (97.8 vs. 81.1%, P = 0.031). There were no statistical differences in clinical success rate, procedure-related adverse events, stent migration rate, stent dysfunction rate, reintervention rate, and overall patient survival time between TLS and AGS groups. The median time to stent dysfunction or patient death in TLS and AGS groups was 53 and 81 days, respectively (P = 0.017). Although AGS had a lower technical success rate than TLS, it was superior to TLS in stent patency in patients with DMBO.

EUS-guided hepaticogastrostomy versus EUS-guided hepaticogastrostomy with antegrade stent placement in patients with unresectable malignant distal biliary obstruction: a propensity score–matched case-control study

Background and aimsEndoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a rescue procedure when endoscopic retrograde cholangiopancreatography fails. Peritonitis and recurrent biliary obstruction (RBO) are adverse events (AEs) associated with EUS-HGS. Antegrade stenting across a malignant distal biliary obstruction (MDBO) followed by EUS-HGS (EUS-HGAS) creates two biliary drainage routes, potentially reducing peritonitis and prolonging time to RBO (TRBO). We compared the outcomes of the two techniques. MethodsData of consecutive patients with MDBO who underwent attempted EUS-HGS or EUS-HGAS across five institutions from January 2014 to December 2020 were retrospectively analyzed. A matched cohort of the patients was obtained using one-to-one propensity score matching. The primary outcome was TRBO, and secondary outcomes included AEs except for RBO and overall survival (OS). ResultsAmong 360 patients, 283 (176 and 107 in the HGS and HGAS groups, respectively) were eligible. The matched cohorts included 81 patients in each group. AEs developed in 10 (12.3%) and 15 (18.5%) patients (p=0.38) in the HGS and HGAS groups, respectively. RBO occurred in 18 and 2 patients in the HGS and HGAS groups, respectively (p<0.001). TRBO was significantly longer in the HGAS group (median 194 vs. 716 days; hazard ratio [HR]=0.050, 95% confidence interval [CI]=0.0066–0.37, p<0.01). However, there was no significant difference in OS between the groups (median 97 vs. 112 days; HR=0.97, 95% CI=0.66–1.4, p=0.88). ConclusionsEUS-HGAS extended TRBO compared with EUS-HGS, while AEs, except for RBO and OS, did not differ. The longer TRBO of EUS-HGAS could benefit patients with longer life expectancy.

Braided-type stent versus laser-cut-type stent for patients with unresectable distal malignant biliary obstruction: a randomized controlled trial

Background and AimsFully covered self-expandable metallic stents (SEMS) are laser-cut (L) or braided (B); however, which is more effective for distal malignant biliary obstruction (DMBO) has been unclear. We compared the clinical outcomes of using L- type and B-type stents because we believe that recurrent biliary obstruction (RBO) is less likely to occur with L-type stents. MethodsPatients diagnosed with unresectable DMBO were randomly assigned to groups L and B in a stratified block fashion, and outcomes were compared. The primary outcome was the rate of RBO within 1 year; secondary outcomes were adverse events, clinical success rate, time to RBO (TRBO), and overall survival. ResultsOf the 60 enrolled participants, 56 (group L: 27, group B: 29) were included. The rates of RBO within 1 year were 44.4% and 17.2% in groups L and B, respectively (odds ratio 2.57 [95% confidence interval {CI}: 1.045–6.353]). Early adverse events, which improved with conservative treatment, included pancreatitis (n=4) in group L and pancreatitis (n=3) and cholecystitis (n=1) in group B (p=0.913). The median TRBO (220 days [95% CI: 56-272] versus 418 days [95% CI: 232-454]) was significantly longer in group B than in group L (log-rank test, p=0.0118). The median overall survival (L: 158 days, B: 204 days) after stenting was not significantly different between the groups (p=0.8544). ConclusionsIn the setting of DMBO, braided (B)-type stents are associated with less recurrent obstruction than laser-cut-type (L) stents, although there was no difference in safety.

Comparison of covered self-expandable metallic stents with 12-mm and 10-mm diameters for unresectable malignant distal biliary obstructions: a prospective randomized trial

Covered self-expandable metallic stents have longer patency than uncovered self-expandable metallic stents for unresectable malignant distal biliary obstruction because of the prevention of tumor ingrowth, and they are removable during reintervention. One main cause of recurrent biliary obstruction in covered self-expandable metallic stents is sludge formation, which can be prevented by using large-bore stents. We evaluated the treatment results of 12-mm and 10-mm covered self-expandable metallic stents for unresectable malignant distal biliary obstructions using a randomized controlled trial. This study was conducted between May 2016 and January 2019 and included 81 consecutive patients with unresectable malignant distal biliary obstruction. The primary endpoint was the rate of nonrecurrent biliary obstruction at 6 months after stent placement. The primary endpoint in the 12-mm group was significantly higher than that in the 10-mm group (P= .0369). Therefore, the median time to recurrent biliary obstruction was 172 days in the 12-mm group and 120 days in the 10-mm group. The median time to recurrent biliary obstruction in the 12-mm group was significantly longer than that in the 10-mm group (P= .0168). Using the 12-mm covered self-expandable metallic stents and receiving chemotherapy were factors affecting the rate of recurrent biliary obstruction in the multivariate analysis. The 12-mm covered self-expandable metallic stents provide a longer time to recurrent biliary obstruction than do 10-mm covered self-expandable metallic stents for managing unresectable malignant distal biliary obstruction. (Clinical trial registration number: UMIN000016911.).

Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis.

Self-expandable metal stent (SEMS) insertion is the standard palliative treatment for unresectable malignant extrahepatic biliary obstruction (MBO). Drawbacks of conventional fully covered SEMS (FCSEMS) and uncovered SEMS (USEMS) include stent migration and tumor ingrowth, respectively. This study aimed to compare stent patency in MBO with the newly design multi-hole SEMS (MHSEMS), which has multiple small side holes in the stent membrane, with conventional FCSEMS and UCSEMS. This retrospective study using a propensity score matching design and stent patency times of 40 patients with MHSEMS was compared to 40 and 34 patients with FCSEMS and UCSEMS during the same period, respectively. Secondary outcomes were procedure-related adverse events, clinical success rate, time to recurrent biliary obstruction (RBO), and etiology of RBO. RBO was compared using Kaplan-Meier analysis. Baseline characteristics after matching were comparable among the 3 groups. RBO rates were 21%, 37%, and 55% for MHSEMS, FCSEMS, and UCSEMS, respectively (p = 0.014), at a mean time of 479, 353, and 306days, respectively (MHSEMS vs UCSEMS, p = 0.002). Rate of tumor ingrowth was highest in the UCSEMS group (42.4% vs 13.2% in MHSEMS; p = 0.005 and vs 0% in FCSEMS; p < 0.001). Stent migration rate was highest in the FCSEMS group at 15.8% vs 2.6% in MHSEMS (p = 0.047) and 0% in UCSEMS (p = 0.005). MHSEMS provided the longest stent patency time with lowest RBO rate compared to conventional SEMS by showing a lower stent migration rate than FCSEMS and a lower tumor ingrowth rate than UCSEMS.

Prospective clinical trial of EUS–guided choledochoduodenostomy without fistula dilation for malignant distal biliary obstruction

ABSTRACT Background and Objectives During EUS–guided choledochoduodenostomy (EUS-CDS), fistula dilation before stent insertion is associated with adverse events (AEs), such as bile leakage and peritonitis. We hypothesized that EUS-CDS without fistula dilation using a novel self-expandable metal stent (SEMS) with a thin delivery system could overcome this problem, and we conducted this study to evaluate its feasibility and safety. Methods This was an open-label, single-arm, phase II study at a single institution. We planned EUS-CDS without fistula dilation using a fully covered SEMS with a 5.9-Fr delivery system for unresectable malignant distal biliary obstruction. The primary outcome was overall technical success. Secondary outcomes were technical success without fistula dilation, procedure time, functional success, time to recurrent biliary obstruction, and AEs. The planned sample size was 25 patients. Results In total, 24 patients were included in this study. In 21 patients, EUS-CDS was performed as primary drainage. The overall technical success rate was 100% (24 of 24 patients). The technical success rate without fistula dilation was 96% (23 of 24). The median procedure time was 16 min (range, 10–66 min). The functional success rate was 96% (23 of 24). The median time to recurrent biliary obstruction was 148 days (95% confidence interval, 29–266 days). There were no procedure-related AEs. Furthermore, computed tomography immediately after the procedure showed no leakage of contrast medium into the abdominal cavity in any patient. Conclusions EUS–guided choledochoduodenostomy without fistula dilation using a fully covered SEMS with a 5.9-Fr delivery system is feasible with a high probability and can be achieved quickly while effectively preventing bile leakage and peritonitis.

A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study.

Endoscopic self-expandable metal stent (SEMS) placement is currently the standard technique for treating unresectable malignant distal biliary obstructions (MDBO). Therefore, covered SEMS with longer stent patency and fewer migrations are required. This study aimed to assess the clinical performance of a novel, fully covered SEMS for unresectable MDBO. This was a multicenter single-arm prospective study. The primary outcome was a non-obstruction rate at 6 months. The secondary outcomes were overall survival (OS), recurrent biliary obstruction (RBO), time to RBO (TRBO), technical and clinical success, and adverse events. A total of 73 patients were enrolled in this study. The non-obstruction rate at 6 months was 61%. The median OS and TRBO were 233 and 216 days, respectively. The technical and clinical success rates were 100% and 97%, respectively. Furthermore, the rate of occurrence of RBO and adverse events was 49% and 21%, respectively. The length of bile duct stenosis (<2.2 cm) was the only significant risk factor for stent migration. The non-obstruction rate of a novel fully covered SEMS for MDBO is comparable to that reported earlier but shorter than expected. Short bile duct stenosis is a significant risk factor for stent migration.

Endoscopic ultrasound-guided gallbladder drainage as a first approach for jaundice palliation in unresectable malignant distal biliary obstruction: Prospective study.

Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in patients with distal malignant biliary obstruction (DMBO). Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. In a palliative setting the endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) could represent an easy and valid option. We performed a prospective study with a new EC-LAMS with the primary aim to assess the clinical success rate of EUS-GBD as a first-line approach to the palliation of DMBO. In all, 37 consecutive patients undergoing EUS-GBD with a new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease >15% within 24 h and >50% within 14 days after EC-LAMS placement. The mean age was 73.5 ± 10.8 years; there were 17 male patients (45.9%). EC-LAMS placement was technically feasible in all patients (100%) and the clinical success rate was 100%. Four patients (10.8%) experienced adverse events, one bleeding, one food impaction, and two cystic duct obstructions because of disease progression. No stent-related deaths were observed. The mean hospitalization was 7.7 ± 3.4 days. Median overall survival was 4 months (95% confidence interval 1-8). Endoscopic ultrasound-guided gallbladder drainage with the new EC-LAMS is a valid option in palliative endoscopic biliary drainage as a first-step approach in low survival patients with malignant jaundice unfit for surgery. A smaller diameter EC-LAMS should be preferred, particularly if the drainage is performed through the stomach, to avoid potential food impaction, which could result in stent dysfunction.

EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial)

Several studies have compared primary endoscopic ultrasound (EUS)-guided biliary drainage to endoscopic retrograde cholangiopancreatography (ERCP) with insertion of metal stents in unresectable malignant distal biliary obstruction (MDBO) and the results were conflicting. The aim of the current study was to compare the outcomes of the procedures in a large-scale study. This was a multicenter international randomized controlled study. Consecutive patients admitted for obstructive jaundice due to unresectable MDBO were recruited. Patients were randomly allocated to receive EUS-guided choledocho-duodenostomy (ECDS) or ERCP for drainage. The primary outcome was the 1-year stent patency rate. Other outcomes included technical success, clinical success, adverse events, time to stent dysfunction, reintervention rates, and overall survival. Between January 2017 and February 2021, 155 patients were recruited (ECDS 79, ERCP 76). There were no significant differences in 1-year stent patency rates (ECDS 91.1% vs ERCP 88.1%, P= .52). The ECDS group had significantly higher technical success (ECDS 96.2% vs ERCP 76.3%, P < .001), whereas clinical success was similar (ECDS 93.7% vs ERCP 90.8%, P= .559). The median (interquartile range) procedural time was significantly shorter in the ECDS group (ECDS 10 [5.75-18] vs ERCP 25 [14-40] minutes, P < .001). The rate of 30-day adverse events (P= 1) and 30-day mortality (P= .53) were similar. Both procedures could be options for primary biliary drainage in unresectable MDBO. ECDS was associated with higher technical success and shorter procedural time then ERCP. Primary ECDS may be preferred when difficult ERCPs are anticipated. This study was registered to Clinicaltrials.gov NCT03000855.

Outcomes of Intraductal Placement of Covered Metal Stents for Unresectable Distal Malignant Biliary Obstruction

Intraductal self-expandable metal stent (SEMS) placement may prolong stent patency by reducing duodenobiliary reflux. This study aimed to evaluate the efficacy and safety of this biliary drainage method in patients with unresectable distal malignant biliary obstruction (MBO). Consecutive patients with unresectable MBO who underwent initial covered SEMS placement between 2015 and 2022 were retrospectively reviewed. We compared the causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates between two biliary drainage methods (SEMSs placed above and across the papilla). A total of 86 patients were included (above: 38 and across: 48). Overall RBO rates (24% vs. 44%, p = 0.069) and median TRBO (11.6 months vs. 9.8 months, p = 0.189) were not significantly different between the two groups. The frequency of overall AEs was similar between the two groups in the entire cohort, but was significantly lower in patients with non-pancreatic cancer (6% vs. 44%, p = 0.035). Reintervention was successfully performed in the majority of patients in both groups. Intraductal SEMS placement was not associated with a prolonged TRBO in this study. Larger studies are warranted to further evaluate the benefit of intraductal SEMS placement.

Double bare metal stent deployment combined with intraductal radiofrequency ablation for malignant distal biliary obstruction: a prospective pilot study

Although uncovered self-expandable metal stents (SEMSs) possess certain advantages such as averting cystic duct obstruction and stent migration, they are susceptible to ingrowth occlusion. The combination of the double bare stent (DBS) and endobiliary radiofrequency ablation (RFA) may reduce ingrowth. Hence, this study aimed to examine the utility of this method for the treatment of unresectable malignant distal biliary obstruction (MDBO). This prospective, single-center, pilot study enrolled 51 patients who met the eligibility criteria between February 2020 and January 2022. The study outcomes included technical success, clinical success, recurrent biliary obstruction (RBO), and other adverse events (AE) besides RBO associated with DBS placement with RFA for MDBO. The technical success rate was 98.0% (50/51). Clinical success was achieved in all patients in whom technical success was achieved. The rates of early and late AEs were 5.9% (3/51) and 8.0% (4/50), respectively. The incidence rate of RBO was 38.0% (19/50). Sludge occlusion, ingrowth occlusion, and overgrowth occlusion occurred in 26.0% (13/50), 8.0% (4/50), and 2.0% (1/50) of patients, respectively (the main cause of RBO was undeterminable in 1 patient). The median time to RBO was 241 days. DBS with RFA showed good technical feasibility, good long-term outcomes, acceptable AE rates, and most importantly, a low ingrowth occlusion rate when employed for the treatment of MDBO.

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.

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. 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. 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). The second intervention with 12-mm CSEMS was associated with a longer TRBO.

Safety and Efficacy of a Large-Bore Biliary Metallic Stent for Malignant Biliary Obstruction.

Self-expandable metallic stents (SEMSs) are typically inserted in patients with unresectable malignant biliary obstruction. However, SEMSs are susceptible to occlusion. To overcome this issue, we developed a large-bore, dumbbell-shaped, fully covered SEMS (FCSEMS-L) and compared its efficacy and safety with those of a conventional FCSEMS (FCSEMS-C) in patients with malignant biliary obstruction. Methods: Patients with unresectable distal malignant biliary obstruction were retrospectively enrolled between January 2011 and February 2021. All patients underwent endoscopic insertion of FCSEMSs. Recurrent biliary obstruction (RBO), patient survival time, complications, and prognosis were analyzed. Results: RBO occurred in 31 patients (35.6%) who received an FCSEMS-L, and in 34 (45.9%) who received an FCSEMS-C. Stent occlusion occurred in 19 patients (21.8%) who received an FCSEMS-L, and in 22 (29.7%) who received an FCSEMS-C. Stent migration occurred in 12 patients (13.8%) with an FCSEMS-L and 12 (16.2%) with an FCSEMS-C. The median time to RBO (TRBO) was 301 days with an FCSEMS-L and 203 days with an FCSEMS-C. The median survival time was 479 days with an FCSEMS-L and 523 days with an FCSEMS-C. The TRBO and patient survival time did not significantly differ between the two groups. Conclusions: There were no significant differences in efficacy and complication rates between the fully covered large bore SEMSs and conventional fully covered SEMSs.

Angle of covered self-expandable metallic stents after placement is a risk factor for recurrent biliary obstruction.

BACKGROUNDStudies have shown that covered self-expandable metallic stents (CSEMS) with a low axial forces after placement can cause early recurrent biliary obstruction (RBO) due to precipitating sludge formation. AIMTo ascertain whether the angle of CSEMS after placement is a risk factor for RBO in unresectable distal malignant biliary obstruction (MBO).METHODSBetween January 2010 and March 2019, 261 consecutive patients underwent self-expandable metallic stent insertion by endoscopic retrograde cholangiopancreatography at our facility, and 87 patients were included in this study. We evaluated the risk factors for RBO, including the angle of CSEMS after placement as the primary outcome. We measured the obtuse angle of CSEMS after placement on an abdominal radiograph using the SYNAPSE PACS system. We also evaluated technical and functional success, adverse events, time to RBO (TRBO), non-RBO rate, survival time, cause of RBO, and reintervention procedure as secondary outcomes.RESULTSWe divided the patients into two cohorts based on the presence or absence of RBO. The angle of CSEMS after placement (per 1° and per 10°) was evaluated using the multivariate Cox proportional hazard analysis, which was an independent risk factor for RBO in unresectable distal MBO [hazard ratio, 0.97 and 0.71; 95% confidence interval (CI): 0.94-0.99 and 0.54-0.92; P = 0.01 and 0.01, respectively]. For early diagnosis of RBO, the cut-off value of the angle of CSEMS after placement using the receiver operating characteristic curve was 130° [sensitivity, 50.0%; specificity 85.5%; area under the curve 0.70 (95%CI: 0.57-0.84)]. TRBO in the < 130° angle group was significantly shorter than that in the ≥ 130° angle group (P < 0.01).CONCLUSIONThis study suggests that the angle of the CSEMS after placement for unresectable distal MBO is a risk factor for RBO. These novel results provide pertinent information for future stent management.

EUS-guided biliary drainage with LAMS for distal malignant biliary obstruction when ERCP fails: single-center retrospective study and maldeployment management.

EUS-guided biliary drainage (EUS-BD) with Lumen Apposing Metal Stent (LAMS) is a mini-invasive approach for jaundice palliation in distal malignant biliary obstruction (D-MBO) not amenable to ERCP, with good efficacy and not exiguous adverse events. From January 2015 to December 2019, we retrospectively enrolled all the EUS-BD with electrocautery-enhanced LAMS for biliary decompression in unresectable D-MBO and failed ERCP. Primary study aims were to evaluate technical/clinical success and AEs rate. In case of maldeployment, we estimated the efficacy of an intra-operative rescue therapy. Secondary aims were to assess the jaundice recurrence and gastric outlet obstruction symptoms. Thirty-six EUS-BD were enrolled over a cohort of 738 patients (ERCP cannulation failure rate was 2.6%): 31 choledocho-duodenostomy and 5 cholecystogastrostomy. A pre-loaded guidewire through the LAMS was systematically used in case of common bile duct ≤ 15mm or scope instability for a safe/preventive biliary entryway in case of intra-procedural complications. Technical success was 80.6% (29/36 patients). Seven cases of LAMS maldeployment during EUS-guided choledocho-duodenostomy were successfully treated with RT by an over-the-wire fully-covered Self-Expandable Metal Stent (FC-SEMS). The FC-SEMS was released through the novel fistula tract in endoscopic fashion in 5/7 cases and transpapillary in percutaneous-transhepatic-endoscopic rendezvous (1/7) and laparoscopic-endoscopic rendezvous (1/7) in the two remaining cases. The total efficacy of rescue therapy was 100%. Same-session duodenal SEMS was placed in 17 patients with optimal gastric outlet obstruction management. Final clinical success was 100% and no other late adverse events or FC-SEMS migration were observed. EUS-BD with LAMS is effective for jaundice palliation after ERCP failure but with considerable adverse events. Maldeployment remains a serious complication with fatal evolution if not correctly recognized/managed. Rescue therapy must be promptly applied especially in tertiary-care centers with highly skilled endoscopists, interventional radiologist and dedicated surgeon.