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 ≤ 15 mm 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.

Di Mitri R ，Amata M ，Mocciaro F ，Conte E ，Bonaccorso A ，Scrivo B ，Scimeca D ... -  《-》

EUS-guided biliary drainage with electrocautery-enhanced lumen-apposing metal stent placement should replace PTBD after ERCP failure in patients with distal tumoral biliary obstruction: a large real-life study.

In cases of malignant distal biliary obstruction, ERCP is the preferred technique for bile duct drainage. In case of failure, the alternative techniques are percutaneous transhepatic biliary drainage (PTBD) and more recently endoscopic ultrasound-guided biliary drainage. A new type of stent called the electrocautery-enhanced lumen-apposing metal stent (EC-LAMS) has been developed to enable the performance of biliary-enteric anastomosis under EUS-guidance in a single step, without prior bile duct puncture or the need for a guidewire. The aim of our study was to compare the real-life efficacies of PTBD and EUS-BD with the EC-LAMS for cases of ERCP failure in patients with malignant biliary obstruction. We performed a monocentric retrospective study comparing PTBD and EUS-BD with the use of electrocautery-enhanced lumen-apposing metal stent in the context of a malignant distal biliary obstruction after ERCP failure. 95 patients were included (50 in EUS-BD group and 45 in PTBD group). The main etiology of malignant obstruction was adenocarcinoma of the head of pancreas (85%). There was a significant difference in favor of endoscopic ultrasound-guided biliary drainage using electrocautery-enhanced lumen-apposing metal stent for the following criteria: clinical success: 89.3% vs. 45.5%; p < 0.0001; procedure-related adverse event rate: 2.12% vs. 22.7%; p = 0.003; duration of post-drainage hospitalization: 3.5 vs. 8.2 days; p < 0.0001, overall survival (median survival): 118.2 vs. 42 days; p = 0.012, overall cost of the strategy per patient: 5098 vs. 9363 euros; p < 0.001. Our results are in favor of EUS-BD using electrocautery-enhanced lumen-apposing metal stent in case of ERCP failure for a distal tumor biliary obstruction. Operators performing ERCP for distal tumor biliary obstruction must learn this backup procedure because of its superiority over percutaneous transhepatic biliary drainage in terms of clinical success, safety, cost, and overall survival.

Ginestet C ，Sanglier F ，Hummel V ，Rouchaud A ，Legros R ，Lepetit H ，Dahan M ，Carrier P ，Loustaud-Ratti V ，Sautereau D ，Albouys J ，Jacques J ，Geyl S ... -  《-》

Lumen apposing metal stents versus tubular self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy in malignant biliary obstruction.

EUS-guided choledochoduodenostomy (EUS-CDS) is an effective option for biliary drainage in malignant biliary obstruction. Lumen apposing metal stents (LAMS) are increasingly been used for EUS-CDS. It is unknown how LAMS compare to tubular self-expandable metal stents (SEMS) for EUS-CDS. Our aim is to compare the clinical outcomes of LAMS versus SEMS for EUS-CDS. Single-center retrospective cohort study of consecutive patients with unresectable malignant biliary obstruction who underwent EUS-CDS after failed ERCP for initial biliary drainage between 2011 and 2019. Clinical outcomes were compared between patients who had conventional covered SEMS and LAMS placed for EUS-CDS. Outcome measures included unplanned procedural events, technical success, clinical success, adverse events and reinterventions. Survival was analyzed by the Kaplan-Meier method. During the study period 57 patients met inclusion criteria (37 LAMS, 20 SEMS). All EUS-CDS were technically successful (LAMS group 95% CI 90.3-100%, SEMS group 95% CI 83.2-100%). There were no differences between groups in unplanned procedural events (4 LAMS deployment issues, 2 mild bleeding in SEMS group; 10 vs 10.8%), clinical success (37/37 [100%] vs 19/20 [95%]), and short-term adverse events (5/37 [13.5%] vs 4/20 [20%], p = 0.71). Complete follow-up data were available in 41 patients for a mean of 376 ± 145 days. Endoscopic reintervention was required for duodenal stent placement (n = 9) or biliary stent dysfunction (n = 4), with no difference between LAMS and SEMS group (6/37 [16.2%] vs 7/20 [35%]). There were no differences in overall survival between both groups. EUS-guided choledochoduodenostomy after failed ERCP has equally high technical and clinical success rates with either LAMS or SEMS in patients with malignant biliary obstruction. No differences in adverse events, reinterventions and survival were seen with either type of stent. The cost-effectiveness of LAMS vs SEMS for EUS-guided choledochoduodenostomy remains to be proven.

de Benito Sanz M ，Nájera-Muñoz R ，de la Serna-Higuera C ，Fuentes-Valenzuela E ，Fanjul I ，Chavarría C ，García-Alonso FJ ，Sanchez-Ocana R ，Carbajo AY ，Bazaga S ，Perez-Miranda M ... -  《-》

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.

Teoh AYB ，Napoleon B ，Kunda R ，Arcidiacono PG ，Kongkam P ，Larghi A ，Van der Merwe S ，Jacques J ，Legros R ，Thawee RE ，Saxena P ，Aerts M ，Archibugi L ，Chan SM ，Fumex F ，Kaffes AJ ，Ma MTW ，Messaoudi N ，Rizzatti G ，Ng KKC ，Ng EKW ，Chiu PWY ... -  《-》

Lumen-apposing metal stents for malignant biliary obstruction: Is this the ultimate horizon of our experience?

Anderloni A ，Troncone E ，Fugazza A ，Cappello A ，Del Vecchio Blanco G ，Monteleone G ，Repici A ... -  《-》