Pancreatic duct strictures; biodegradable self-expandable versus plastic stents, a randomized trial
- Conditions
- Chronic pancreatitis/chronische pancreatitisPancreatic duct strictures/Ductus pancreaticus stricturen
- Registration Number
- NL-OMON22266
- Lead Sponsor
- Erasmus University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 38
Inclusion Criteria
Chronic pancreatitis patients with a symptomatic fibrotic PD stricture (located proximal from the spine), for which endoscopic drainage is considered.
Exclusion Criteria
1. Age <18 years
2. Contra-indication for endoscopy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is the number of therapeutic interventions during the 24 months follow-up period (defined as therapeutic endoscopic procedures related to the pancreatic duct stricture or pancreatic pain (ERCP, insertion of feeding tubes) and surgical procedures.<br>
- Secondary Outcome Measures
Name Time Method 1. Clinical success, defined as no need for further PD drainage after stent extraction or resolution.<br /><br>2. Complications.<br /><br>3. Pain relief, defined as complete; Izbicki score <10, or partial; >50% decrease.<br /><br>4. Stricture recurrence, defined as need for a re-intervention for a PD stricture after stent extraction or resolution.<br /><br>5. Conversion to surgery.<br>