Trial Information
Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
Inclusion Criteria:
- pancreatic pseudocyst, at least 6 cm in diameter
- symptomatic pancreatic pseudocyst
- increasing size of pancreatic pseudocyst within 6 weeks
Exclusion Criteria:
- Pregnancy
- Age less than 18 years
- Postoperative status preventing access to papilla
- Allergy to contrast preventing from ERP
- Missing informed consent to study
- PTT above 1.5 times of normal, unless substituted
- Platelet count less than 50.000/µl, unless substituted
- Pancreatic ascites or fistula
- Life expectancy less than 2 years
- Percutaneously drained cysts are not part of the study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recurrence of pancreatic pseudocyst
Outcome Description:
-
Outcome Time Frame:
two years
Safety Issue:
No
Principal Investigator
Mark Ellrichmann, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany
Authority:
Germany: Ethics Commission
Study ID:
UKSH-122010
NCT ID:
NCT01276002
Start Date:
January 2011
Completion Date:
June 2014
Related Keywords:
- Chronic Acute Pancreatitis
- disrupted duct
- pancreatic pseudocysts
- Pancreatic Pseudocyst
- Pancreatitis