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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:
ClinicalTrials.gov Identifier:
NCT01276002
First Posted: January 13, 2011
Last Update Posted: December 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark Ellrichmann, University of Schleswig-Holstein
January 12, 2011
January 13, 2011
December 7, 2015
January 2011
December 2016   (Final data collection date for primary outcome measure)
Recurrence of pancreatic pseudocyst [ Time Frame: two years ]
Same as current
Complete list of historical versions of study NCT01276002 on ClinicalTrials.gov Archive Site
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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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
December 2016
December 2016   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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
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Mark Ellrichmann, University of Schleswig-Holstein
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
December 2015

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