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Videoendoscopic Drainage of Infected Pancreatic Collections

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ClinicalTrials.gov Identifier: NCT00061269
Recruitment Status : Completed
First Posted : May 23, 2003
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:

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 or disease Intervention/treatment Phase
Pancreatitis, Acute Necrotizing Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : September 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: VARD
Videoscopic-Assisted Retroperitoneal Debridement (VARD)
Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00061269


Locations
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United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Veteran's Administration-Portland
Portland, Oregon, United States, 97239
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Veteran's Administration Puget Sound
Seattle, Washington, United States, 98108
University of Washington
Seattle, Washington, United States, 98195
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00061269     History of Changes
Other Study ID Numbers: VDIPC (completed)
R03DK061362 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2003    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases