Endoscopic cutting of the constrictor (sphincter) muscle of the bile ducts before placement of a metal tube (stent) to lower the risk of an inflammation of the pancreas
Not Applicable
Completed
- Conditions
- <p>Malignant biliary obstruction Endoscopic biliary sphincterotomy Post-ERCP pancreatitis</p>10019811
- Registration Number
- NL-OMON21209
- Lead Sponsor
- Cook medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 518
Inclusion Criteria
- Indication for fully covered self-expandable metal stent placement
- (Suspected) malignant biliary outflow obstruction
Exclusion Criteria
- Hilar biliary obstruction, defined as stenosis located within 2 cm of the hilum
- Biliary SEMS or more than 1 plastic endoprothesis in situ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of post-ERCP pancreatitis</p><br>
- Secondary Outcome Measures
Name Time Method <p>- 30-days ERCP-related morbidity<br /><br>- 30 days stent-related morbidity<br /><br>- 30 days mortality<br /><br>- Technical success of stent placement</p><br>