NL-OMON39445
Recruiting
Not Applicable
Biodegradable self-expandable stents for pancreatic duct strictures due to chronic pancreatitis - BSPD study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic duct obstruction
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. A diagnosis of chronic pancreatitis, based on clinical symptoms in combination with morphological changes established by imaging studies (atrophy, calcifications or ductal changes) and/or pancreatic functional insufficiency.
- •2\. A benign fibrotic pancreatic duct stricture.
- •3\. Previous endoscopic dilatation with plastic stents for at least 6 months has failed to resolve this stricture.
Exclusion Criteria
- •1\. Age less than 18 years
- •2\. Contra\-indication for endoscopy; Roux\-en\-Y reconstruction
- •3\. Suspected pancreatic malignancy
- •4\. Limited life expectancy due to co\-morbidity (\< 1 year)
- •5\. Pregnancy
Outcomes
Primary Outcomes
Not specified
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