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

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ClinicalTrials.gov Identifier: NCT01276002
Recruitment Status : Unknown
Verified December 2015 by Mark Ellrichmann, University of Schleswig-Holstein.
Recruitment status was:  Recruiting
First Posted : January 13, 2011
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Mark Ellrichmann, University of Schleswig-Holstein

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Acute Pancreatitis Procedure: pancreatic duct stenting Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence of pancreatic pseudocyst [ Time Frame: two years ]

Eligibility Criteria
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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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 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