Spots Global Cancer Trial Database for LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

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

Study ID: NCT04595058

Conditions

Biliary Obstruction

Pancreatic Cancer

Biliary Tract Neoplasms

Interventions

Double pigtail plastic stent through lumen-apposing metal stent

Lumen-apposing metal stent without double pigtail plastic stent

Study Description

Brief 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.

Detailed 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.