acute pancreatitis systematic pancreatic fluid collection endoscopic transmural drainage self-expandable metal stent
Conditions
Interventions
Endoscopic transmural drainage of pancreatic fluid collecting with placement of self-expandable metal stent.
Sponsors
University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient over 17 years; 2. Symptomatic pancreatic fluid collection that requires endoscopic drainage.
Exclusion criteria
Exclusion criteria: 1. Infected pancreatic necrosis; 2. Recurrence of prior treated pancreatic fluid collection; 3. Not fulfilling standard criteria to undergo PFC drainage according to local guidelines; 4. ASA class IV or V.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are safety and efficacy: 1. Safety is expressed as the number of SAEs that are related to the procedure; 2. Efficacy is expressed as the number of PFC resolutions at 3 months after drainage. The intervention is considered safe when the maximum rate of SAE’s (related to the treatment) is 5%. The procedure is regarded effective if at least 85% of PFC have been resolved at 3 months. PFC resolution is defined as a PFC < 3 cm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ‘Ease of use’ measured as the scope-in and scope-out time interval during the procedure in which the SEMS is placed; 2. Removability of covered self-expendable metallic stent after PFC resolution. 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. | — |
Contacts
Public ContactTessa Verlaan
Dept. of Gastroenterology and Hepatology/ Dept. of Surgery Academic Medical Center Amsterdam Meibergdreef 9
Outcome results
None listed