Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts. (Disduct)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2015 by 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 Endpoint Classification: Safety/Efficacy Study 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:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
U.S. FDA Resources
Further study details as provided by University of Schleswig-Holstein:
Primary Outcome Measures:
- Recurrence of pancreatic pseudocyst [ Time Frame: two years ] [ Designated as safety issue: No ]
| 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) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by 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 September 26, 2016