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

Albert Garcia-Sumalla, Carme Loras, Vicente Sanchiz, Rafael Pedraza Sanz, Enrique Vazquez-Sequeiros, Jose Ramon Aparicio, Carlos de la Serna-Higuera, Daniel Luna-Rodriguez, Xavier Andujar, María Capilla, Tatiana Barberá, Jose Ramon Foruny-Olcina, Belen Martínez, Miguel Dura, Silvia Salord, Berta Laquente, Cristian Tebe, Sebastia Videla, Manuel Perez-Miranda, Joan B Gornals, Spanish Working Group on Endoscopic Ultrasound Guided Biliary Drainage, Albert Garcia-Sumalla, Carme Loras, Vicente Sanchiz, Rafael Pedraza Sanz, Enrique Vazquez-Sequeiros, Jose Ramon Aparicio, Carlos de la Serna-Higuera, Daniel Luna-Rodriguez, Xavier Andujar, María Capilla, Tatiana Barberá, Jose Ramon Foruny-Olcina, Belen Martínez, Miguel Dura, Silvia Salord, Berta Laquente, Cristian Tebe, Sebastia Videla, Manuel Perez-Miranda, Joan B Gornals, Spanish Working Group on Endoscopic Ultrasound Guided Biliary Drainage

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.gov NCT04595058 . Registered on October 14, 2020.

Keywords: Biliary drainage; Choledochoduodenostomy; Endoscopic ultrasound; Lumen-apposing metal stent; Malignant biliary obstruction; Plastic stent; Trial.

Conflict of interest statement

- A Garcia-Sumalla is a PhD student at the Faculty of Medicine and Health Sciences, University of Barcelona, and this paper is part of his doctoral project.

- JB Gornals acts as a PhD Director; is a consultant for Boston Scientific and has received a research grant from this company.

- M Pérez-Miranda is a consultant and speaker for Medtronic, Olympus, Taewoong, and M.I.Tech.

- E Vazquez-Sequeiros is a consultant for Boston Scientific.

- JR Aparició is a consultant for Boston Scientific.

- The other authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Enrollment, interventions, and assessment in the BAMPI trial (SPIRIT-Figure). ªMandatory only in case of NOT meeting clinical success criteria on a previous visit (14 days).BRI biliary reintervention; d days; EUS-BD, endoscopic ultrasound-guided biliary drainage
Fig. 2
Fig. 2
BAMPI trial Flowchart. DPS double-pigtail plastic stent, ERCP endoscopic retrograde cholangio-pancreatography, EUS-BD endoscopic ultrasound-guided biliary drainage, EE-LAMS, electrocautery-enhanced, lumen-apposing metal stent

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