Clinical Trial

Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Ducts: Comparing Two Types of Endoscopically Placed Internal Stents to Prevent Blockage of a Lumen Apposing Metal Stent

Study acronym: Opti-LAMS
Not Yet Recruiting
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Summary
This study looks at the best way to treat bile duct blockage in people with advanced cancer that cannot be removed by surgery. A blocked bile duct can cause serious symptoms like yellowing of the skin (jaundice), infection, and pain. A common procedure called ERCP sometimes doesn't work in these patients. A newer method called EUS-guided choledochoduodenostomy (EUS-CDS) uses internal ultrasound to place a special metal tube (called a LAMS) to allow bile to drain. However, over time this stent can still become blocked. To reduce this risk, doctors can place a second stent inside the first. This study is comparing two types of these second stents: * A plastic stent (double pigtail stent or DPS) * A metal stent (fully covered self-expanding metal stent or FCSEMS) The study will include patients at Waikato Hospital. After the first stent is placed, they will be randomly assigned to receive either a DPS or FCSEMS. Patients will be followed for 6 months to see how well the stents work. The aim is to find out which approach keeps the bile duct open longer and reduces the need for further procedures or hospitalisation, helping improve care and comfort for people with advanced cancer
Trial Details
NCT Number NCT07115420
Lead Sponsor Waikato Hospital
Conditions Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma, Inoperable Malignant Biliary Obstruction, Lumen Apposing Metal Stents
Enrollment 100 participants
Start Date 2025-09
Primary Completion 2027-09 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2025-08-11