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

This study is currently recruiting participants.

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Contacts and Locations

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

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 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.

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary pancreatitis

MedlinePlus related topics: Endoscopy Pancreatitis

U.S. FDA Resources

Further study details as provided by Mark Ellrichmann, University of Schleswig-Holstein:

Primary Outcome Measures:

Recurrence of pancreatic pseudocyst [ Time Frame: two years ]


Estimated Enrollment:	120
Study Start Date:	January 2011
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


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 Submitted:	January 12, 2011
First Posted:	January 13, 2011
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

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