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

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...

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Detalles Bibliográficos
Autores: Garcia Sumalla, Albert, Loras, Carme, Sanchiz, Vicente, Pedraza Sanz, Rafael, Vazquez Sequeiros, Enrique, Aparicio, Jose Ramon, Serna Higuera, Carlos de la, Luna Rodriguez, Daniel, Andujar, Xavier, Capilla, María, Barberá, Tatiana, Foruny Olcina, José Ramón, Martínez, Belen, Dura, Miguel, Salord, Silvia, Laquente, Berta, Tebé, Cristian, Videla, Sebastià, Perez Miranda, Manuel, Gornals Soler, Joan B., Spanish Working Group on Endoscopic Ultrasound Guided Biliary Drainage
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/184396
Acceso en línea:https://hdl.handle.net/2445/184396
Access Level:acceso abierto
Palabra clave:Assaigs clínics
Malalties del tracte biliar
Endoscòpia
Colèstasi
Clinical trials
Bilious diseases and biliousness
Endoscopy
Cholestasis
Descripción
Sumario: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.

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