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Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts. (Disduct)

This study is currently recruiting participants.
Verified January 2011 by University of Schleswig-Holstein
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01276002
First received: January 12, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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:

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: June 2014
Estimated Primary Completion Date: June 2012 (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
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
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

No publications provided

Responsible Party: Annette Fritscher-Ravens/Prof. Dr., Interdisciplinary Endoscopy, Universityclinic Schleswig-Holstein, Campus Kiel, Germany
ClinicalTrials.gov Identifier: NCT01276002     History of Changes
Other Study ID Numbers: UKSH-122010
Study First Received: January 12, 2011
Last Updated: January 12, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
disrupted duct
pancreatic pseudocysts

Additional relevant MeSH terms:
Pancreatic Pseudocyst
Pancreatitis
Pancreatic Cyst
Cysts
 Neoplasms
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013