Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Not Applicable
Recruiting
- Conditions
- Malignant Bile Duct Obstruction
- Registration Number
- NCT04805450
- Lead Sponsor
- Istituto Clinico Humanitas
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1075
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction. During procedure
- Secondary Outcome Measures
Name Time Method To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation. periprocedural and 30 days
Trial Locations
- Locations (1)
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Istituto Clinico Humanitas🇮🇹Rozzano, Milano, Italy