Biodegradable self-expandable stents for pancreatic duct strictures due to chronic pancreatitis

Recruiting

• Conditions: Pancreatic duct obstruction; Pancreatic duct stricture; 10018008

• Registration Number: NL-OMON39445
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is safety. Therefor, all complications will be<br /><br>documented.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are;<br /><br><br /><br>Successful stent placement<br /><br>Stent resolution<br /><br>Clinical success; pain relief<br /><br>Technical success; stricture resolution</p><br>