Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction\u2014BAMPI TRIAL: an open-label, randomized controlled trial protocol

Albert García-Sumalla ,Tatiana Barberá,Rafael Pedraza Sanz,Carme Loras,Enrique Vázquez-Sequeiros ,Belén Martínez ,Sílvia Salord ,José Ramón Foruny ,Carlos De La Serna‐Higuera ,Cristian Tebé ,Sebastià Videla ,Xavier Andújar ,Daniel Luna-Rodriguez,Mercedes Ramón Capilla ,Miguel Durà ,Vicente Sánchiz ,Manuel Pérez-Miranda ,Berta Laquente,José Ramón Aparicio ,Joan B Gornals

doi:10.1186/s13063-022-06106-1

Abstract

BackgroundIt is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction.Methods/designThis is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate).DiscussionThe BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction.Trial registrationClinicalTrials.govNCT04595058. Registered on October 14, 2020.

Highlights

The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting double-pigtail plastic stent (DPS) through lumen-apposing meal stent (LAMS) is superior to LAMS alone to prevent stent dysfunction
Transpapillary stenting by endoscopic retrograde cholangiopancreatography (ERCP) remains the gold standard treatment for malignant biliary obstruction (MBO), but may fail in up to 15% of cases, and it carries the risks of post-ERCP pancreatitis and stent dysfunction secondary to tumor ingrowth and/or overgrowth [1, 2]
Currently, in vogue in the recent literature is reporting that Endoscopic ultrasound (EUS)-biliary drainage (BD) (CDS type) using EE-LAMS is an effective and safe technique for biliary decompression in patients who failed ERCP [5, 6, 10,11,12, 23]

Summary

Introduction

Background Transpapillary stenting by endoscopic retrograde cholangiopancreatography (ERCP) remains the gold standard treatment for malignant biliary obstruction (MBO), but may fail in up to 15% of cases, and it carries the risks of post-ERCP pancreatitis and stent dysfunction secondary to tumor ingrowth and/or overgrowth [1, 2] For these reasons, since the emergence of Endoscopic Ultrasound-guided biliary drainage (EUS-BD) using electrocautery-enhanced (EE) lumen-apposing metal stents (LAMS), by creating a choledochoduodensotomy (CDS), it has been proposed as a viable alternative to ERCP [3, 4]. A recent retrospective study by our group did not encounter sufficient evidence to recommend its routine use [19] It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction

Objectives

Methods

Findings

Conclusion