Chronic Acute Pancreatitis Clinical Trial
— DisductOfficial title:
Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.
NCT number | NCT01276002 |
Other study ID # | UKSH-122010 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2011 |
Est. completion date | December 2016 |
Verified date | June 2022 |
Source | University Hospital Schleswig-Holstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical recovery and avoidance of recurrence of pancreatic pseudocysts.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel | Kiel |
Lead Sponsor | Collaborator |
---|---|
University Hospital Schleswig-Holstein |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of pancreatic pseudocyst | two years |