NCT04805450

Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,075 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered \[1\]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents \[2-5\]. The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.

Conditions

• Malignant Bile Duct Obstruction

Interventions

Type	Name	Description
PROCEDURE	ES before fully covered SEMS placement
PROCEDURE	no ES before fully covered SEMS placement

Timeline

• Start date: 2015-10-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-03-18
• Last updated: 2023-03-21

Locations

1 site across 1 country: Italy