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
; 23(1): 181, 2022 Feb 25.
Article
em En
| MEDLINE
| ID: mdl-35216619
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.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Colestase
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Endossonografia
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Prognostic_studies
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Qualitative_research
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article