Videoendoscopic Drainage of Infected Pancreatic Collections

This study has been completed.

First Received on May 22, 2003. Last Updated on January 12, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis

U.S. FDA Resources

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00061269 History of Changes
Other Study ID Numbers:	VDIPC (completed)
Study First Received:	May 22, 2003
Last Updated:	January 12, 2010
Health Authority:	United States: Federal Government

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

Infected pancreatic necrosis

Additional relevant MeSH terms:

Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012