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Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts. (Disduct)
This study is currently recruiting participants.
Verified December 2015 by Mark Ellrichmann, University of Schleswig-Holstein
Sponsor:
University of Schleswig-Holstein
Information provided by (Responsible Party):
Mark Ellrichmann, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01276002
First received: January 12, 2011
Last updated: December 4, 2015
Last verified: December 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Chronic Acute Pancreatitis | Procedure: pancreatic duct stenting |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts. |
Resource links provided by NLM:
Further study details as provided by Mark Ellrichmann, University of Schleswig-Holstein:
Primary Outcome Measures:
- Recurrence of pancreatic pseudocyst [ Time Frame: two years ]
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: No stenting
Control group, no stenting of the pancreatic duct in case of a disrupted duct
|
|
|
Active Comparator: Pancreatic duct stenting
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting in this arm
|
Procedure: pancreatic duct stenting
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01276002
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276002
Contacts
| Contact: Mark Ellrichmann, MD | +494315972075 | mark.ellrichmann@uk-sh.de | |
| Contact: Annette Fritscher-Ravens, MD, PhD | +494315972075 | fri.rav@btopenworld.com |
Locations
| Germany | |
| Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel | Recruiting |
| Kiel, Germany, 24105 | |
| Contact: Mark Ellrichmann, MD +494315972075 mark.ellrichmann@uk-sh.de | |
| Contact: Annette Fritscher-Ravens, MD, PhD +494315972075 fri.rav@btopenworld.com | |
| Principal Investigator: Mark Ellrichmann, MD | |
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
| Principal Investigator: | Mark Ellrichmann, MD | Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany |
| Study Director: | Annette Fritscher-Ravens, MD, PhD | Interdisciplinary Endoscopy, University hospital Schleswig-Holstein, Campus Kiel, Germany |
More Information
| Responsible Party: | Mark Ellrichmann, Head Interdisciplinary Endoscopy, University of Schleswig-Holstein |
| ClinicalTrials.gov Identifier: | NCT01276002 History of Changes |
| Other Study ID Numbers: |
UKSH-122010 |
| Study First Received: | January 12, 2011 |
| Last Updated: | December 4, 2015 |
Keywords provided by Mark Ellrichmann, University of Schleswig-Holstein:
|
disrupted duct pancreatic pseudocysts |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatic Pseudocyst Pancreatic Diseases Digestive System Diseases |
Pancreatic Cyst Cysts Neoplasms |
ClinicalTrials.gov processed this record on June 23, 2017