Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Not Applicable
Recruiting
- Conditions
- Malignant Bile Duct Obstruction
- Interventions
- Procedure: ES before fully covered SEMS placementProcedure: no ES before fully covered SEMS placement
- 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
- Arm && Interventions
Group Intervention Description ES before SEMS placement ES before fully covered SEMS placement ERCP with ES before biliary fully covered SEMS placement. no ES before SEMS placement no ES before fully covered SEMS placement ERCP without ES before biliary fully covered SEMS placement.
- 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