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2022-02-25

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cc-by (c) Garcia Sumalla, Albert et al., 2022
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/184396

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

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Recurs relacionat

https://doi.org/10.1186/s13063-022-06106-1

Resum

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.

Matèries

Assaigs clínics, Malalties del tracte biliar, Endoscòpia, Colèstasi

Matèries (anglès)

Clinical trials, Bilious diseases and biliousness, Endoscopy, Cholestasis

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Articles publicats en revistes (Patologia i Terapèutica Experimental)
Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

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, TEBE, Cristian, VIDELA, Sebastià, PEREZ MIRANDA, Manuel, GORNALS SOLER, Joan b., Spanish Working Group on Endoscopic Ultrasound Guided Biliary Drainage. 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. _Trials_. 2022. Vol. 23, núm. 181. [consulta: 22 de gener de 2026]. ISSN: 1745-6215. [Disponible a: https://hdl.handle.net/2445/184396]

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