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.
Por:
Garcia-Sumalla A, Loras C, Sanchiz V, Sanz RP, Vazquez-Sequeiros E, Aparicio JR, de la Serna-Higuera C, Luna-Rodriguez D, Andujar X, Capilla M, Barberá T, Foruny-Olcina JR, Martínez B, Dura M, Salord S, Laquente B, Tebe C, Videla S, Perez-Miranda M, Gornals JB and Spanish Working Group on Endoscopic Ultrasound Guided Biliary Drainage
Publicada:
25 feb 2022
Ahead of Print:
25 feb 2022
Resumen:
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.
Filiaciones:
Garcia-Sumalla A:
Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain
University of Barcelona, Barcelona, Spain
Loras C:
Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, CIBERehd, Terrassa, Spain
Health Sciences, Universitat Oberta de Catalunya, Barcelona, Spain
Sanchiz V:
Endoscopy Unit, Department of Digestive Diseases, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain
Sanz RP:
Endoscopy Unit, Department of Digestive Diseases Endoscopy Unit, Hospital General Universitario de Castellón, Castelló de la Plana, Spain
Vazquez-Sequeiros E:
Endoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain
:
Endoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante
Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain
de la Serna-Higuera C:
Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Rio Hortega, Valladolid, Spain
Luna-Rodriguez D:
Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain
University of Barcelona, Barcelona, Spain
Andujar X:
Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, CIBERehd, Terrassa, Spain
Capilla M:
Endoscopy Unit, Department of Digestive Diseases, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain
Barberá T:
Endoscopy Unit, Department of Digestive Diseases Endoscopy Unit, Hospital General Universitario de Castellón, Castelló de la Plana, Spain
Foruny-Olcina JR:
Endoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain
:
Endoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante
Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain
Dura M:
Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Rio Hortega, Valladolid, Spain
Salord S:
Hepato-Bilio-Pancreatic Unit, Digestive Diseases Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
Laquente B:
Clinical Oncology Department, Hospital Duran y Reynalds, Institu Oncologic de Catalunya, Barcelona, Catalonia, Spain
Tebe C:
Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain
Biostatistics Unit, Institute of Biomedical Research of Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain
Videla S:
Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain
University of Barcelona, Barcelona, Spain
Clinical Research and Clinical Trial Unit (UICEC), Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
Perez-Miranda M:
Endoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante
Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain
Gornals JB:
Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.
Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.
University of Barcelona, Barcelona, Spain.
Health Sciences, Universitat Oberta de Catalunya, Barcelona, Spain.
Green Published, Green Submitted, gold
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