1. 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.
- Author
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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, and Gornals, Joan B.
- Subjects
ENDOSCOPIC ultrasonography ,METALS ,SURVIVAL rate ,BILIRUBIN ,PROGNOSIS - 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]
- Published
- 2022
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