Transluminal drainage of pancreatic fluid collections using a self-expandable metallic stent.
- Conditions
- acute pancreatitissystematic pancreatic fluid collectionendoscopic transmural drainageself-expandable metal stent
- Registration Number
- NL-OMON23102
- Lead Sponsor
- niversity Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
1. Patient over 17 years;
2. Symptomatic pancreatic fluid collection that requires endoscopic drainage.
Exclusion Criteria
1. Infected pancreatic necrosis;
2. Recurrence of prior treated pancreatic fluid collection;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints are safety and efficacy:<br /><br>1. Safety is expressed as the number of SAEs that are related to the procedure;<br /><br>2. Efficacy is expressed as the number of PFC resolutions at 3 months after drainage.<br><br /><br /><br>The intervention is considered safe when the maximum rate of SAE’s (related to the treatment) is 5%.<br /><br>The procedure is regarded effective if at least 85% of PFC have been resolved at 3 months.<br>PFC resolution is defined as a PFC < 3 cm.
- Secondary Outcome Measures
Name Time Method 1. ‘Ease of use’ measured as the scope-in and scope-out time interval during the procedure in which the SEMS is placed;<br /><br>2. Removability of covered self-expendable metallic stent after PFC resolution.<br><br /><br /><br>Removability and ease of use will be graded on a visual analogue scale of 0-10: 0 being not able to remove the SEMS and 10 very easy removal of the SEMS.