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Videoendoscopic Drainage of Infected Pancreatic Collections

Primary Purpose

Pancreatitis, Acute Necrotizing

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Videoscopic-Assisted Retroperitoneal Debridement (VARD)
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Acute Necrotizing focused on measuring Infected pancreatic necrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health Sciences University
  • Veteran's Administration-Portland
  • Harborview Medical Center
  • Veteran's Administration Puget Sound
  • University of Washington
  • University of Toronto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VARD

Arm Description

Videoscopic-Assisted Retroperitoneal Debridement (VARD)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 22, 2003
Last Updated
September 7, 2018
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00061269
Brief Title
Videoendoscopic Drainage of Infected Pancreatic Collections
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2003 (Actual)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Acute Necrotizing
Keywords
Infected pancreatic necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VARD
Arm Type
Experimental
Arm Description
Videoscopic-Assisted Retroperitoneal Debridement (VARD)
Intervention Type
Procedure
Intervention Name(s)
Videoscopic-Assisted Retroperitoneal Debridement (VARD)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Veteran's Administration-Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Veteran's Administration Puget Sound
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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Videoendoscopic Drainage of Infected Pancreatic Collections

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