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

Istituto Clinico Humanitas1 site in 1 country1,075 target enrollmentOctober 1, 2015

ConditionsMalignant Bile Duct Obstruction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Malignant Bile Duct Obstruction
Sponsor: Istituto Clinico Humanitas
Enrollment: 1075
Locations: 1
Primary Endpoint: To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 1, 2015

End Date

December 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Istituto Clinico Humanitas

Responsible Party

Principal Investigator

Michele Tedeschi

Istituto Clinico Humanitas

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.

Time Frame: During procedure

Secondary Outcomes

To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.(periprocedural and 30 days)