e-Article
Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction—BAMPI TRIAL: an open-label, randomized controlled trial protocol.
Document Type
Article
Author
Garcia-Sumalla, Albert; Loras, Carme; Sanchiz, Vicente; Sanz, Rafael Pedraza; Vazquez-Sequeiros, Enrique; Aparicio, Jose Ramon; de la Serna-Higuera, Carlos; Luna-Rodriguez, Daniel; Andujar, Xavier; Capilla, María; Barberá, Tatiana; Foruny-Olcina, Jose Ramon; Martínez, Belen; Dura, Miguel; Salord, Silvia; Laquente, Berta; Tebe, Cristian; Videla, Sebastia; Perez-Miranda, Manuel; Gornals, Joan B.
Source
Subject
*ENDOSCOPIC ultrasonography
*METALS
*SURVIVAL rate
*BILIRUBIN
*PROGNOSIS
*
*
*
*
Language
ISSN
1745-6215
Abstract
Background: 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. Methods/design: This 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). Discussion: The 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 registration: ClinicalTrials.govNCT04595058. Registered on October 14, 2020. [ABSTRACT FROM AUTHOR]