Videoendoscopic Drainage of Infected Pancreatic Collections

NCT ID: NCT00061269

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatitis, Acute Necrotizing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VARD

Videoscopic-Assisted Retroperitoneal Debridement (VARD)

Group Type EXPERIMENTAL

Videoscopic-Assisted Retroperitoneal Debridement (VARD)

Intervention Type PROCEDURE

Interventions

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Videoscopic-Assisted Retroperitoneal Debridement (VARD)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Veteran's Administration-Portland

Portland, Oregon, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Veteran's Administration Puget Sound

Seattle, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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R03DK061362

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VDIPC (completed)

Identifier Type: -

Identifier Source: org_study_id

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