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Videoendoscopic Drainage of Infected Pancreatic Collections

This study has been completed.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00061269
  Purpose

The VARD (Videoendoscopic Assisted Retroperitoneal Drainage) approach as treatment for necrotizing pancreatitis proposes an alternative to standard complicated open abdomen treatment methods.

This treatment involves making a small incision and looking inside the abdomen with a videoendoscope. A videoendoscope is an instrument with a small camera and light on the end. It also has an extension tool that the surgeon can use to clean out any dead and infected tissue in the abdomen.

This approach may reveal a treatment opportunity with faster recovery potential and shorter hospitalizations for patients with necrotizing pancreatitis.


Condition Intervention Phase
Pancreatitis, Acute Necrotizing
Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD)
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:   40
Study Start Date:   September 2003

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • Pancreatic necrosis or peripancreatic fluid collection following acute pancreatitis noted on CT scan
  • Infected pancreatic necrosis or pancreatic abscess and determined by + FNA (gram stain or culture), as defined by the Atlanta Symposium
  • Not neutropenic or pregnant
  • No prior necrosectomy
  • No pancreatic pseudocyst, either sterile or infected
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061269

Locations
United States, Oregon
Oregon Health Sciences University    
      Portland, Oregon, United States, 97239
Veteran's Administration-Portland    
      Portland, Oregon, United States, 97239
United States, Washington
University of Washington    
      Seattle, Washington, United States, 98195
Harborview Medical Center    
      Seattle, Washington, United States, 98104
Veteran's Administration Puget Sound    
      Seattle, Washington, United States, 98108
Canada, Ontario
University of Toronto    
      Toronto, Ontario, Canada

Sponsors and Collaborators
  More Information


Study ID Numbers:   VDIPC
First Received:   May 22, 2003
Last Updated:   November 28, 2007
ClinicalTrials.gov Identifier:   NCT00061269
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Infected pancreatic necrosis  

Study placed in the following topic categories:
Necrosis
Digestive System Diseases
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Pancreatitis

ClinicalTrials.gov processed this record on November 30, 2008




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