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LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent — BAMPI  

Pancreatic Cancer Clinical Trial

Official title:
Multicenter, Randomized and Comparative Study of Lumen-apposing Metal Stents With or Without Coaxial Plastic Stent for Endoscopic Ultrasound-guided Transmural Biliary Drainage

Clinical Trial Summary

The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with and without a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies (CDS) for the management of biliary obstruction.

Clinical Trial Description

The introduction of specific biliary lumen-apposing metal stents (LAMS) represented a great technical improvement in EUS-guided transmural Biliary drainage (BD) of distal malignant biliary obstruction Data is still limited, but recent studies and reviews have been reported with acceptable technical and clinical success. However, some concerns exist regarding its safety, as secondary adverse events There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided choledochoduodenostomy (CDS). Our hypothesis is that adding a coaxial plastic stent may offer benefits in terms of safety in CDS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04595058
Study type Interventional
Source Hospital Universitari de Bellvitge
Contact
Status Completed
Phase N/A
Start date November 17, 2020
Completion date October 17, 2023
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