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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

January 12, 2011
January 12, 2011
January 2011
June 2012   (final data collection date for primary outcome measure)
Recurrence of pancreatic pseudocyst [ Time Frame: two years ] [ Designated as safety issue: No ]
-
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.
Randomized Multicenter Study on Pancreatic Duct Stenting in Disrupted or Obstructed Ducts in Context With Endoscopic Treatment of Pancreatic Pseudocysts.

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Acute Pancreatitis
Procedure: pancreatic duct stenting
in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.
  • 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
    Intervention: Procedure: pancreatic duct stenting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
June 2014
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mark Ellrichmann, MD +494315972075 mark.ellrichmann@uk-sh.de
Contact: Annette Fritscher-Ravens, MD, PhD +494315972075 fri.rav@btopenworld.com
Germany
 
NCT01276002
UKSH-122010
No
Annette Fritscher-Ravens/Prof. Dr., Interdisciplinary Endoscopy, Universityclinic Schleswig-Holstein, Campus Kiel, Germany
University of Schleswig-Holstein
Not Provided
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
University of Schleswig-Holstein
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP