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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
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:


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
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

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 July 29, 2014