CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
EUS-BD with LAMS +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03870386
NCT03870386N/ACompleted

EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial

In Brief

A clinical study evaluating EUS-BD with LAMS and ERCP for Biliary Obstruction. Completed, enrolled 144 participants across 11 sites in 2 countries.

Detailed Summary

Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, France
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 12, 2019
Enrollment StartMar 8, 2019
Primary CompletionMay 1, 2023
Study CompletionJul 1, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.3 years ago

Interventions

EUS-BD with LAMSprocedure

Endoscopic ultrasound guided insertion of lumen apposing metal stent forming a choledochoduodenostomy

ERCPprocedure

Endoscopic retrograde cholangiopancreatography to localize and cannulate the bile duct using the guidewire-assisted technique.