NCT00061269

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2003

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

5 years

First QC Date

May 22, 2003

Last Update Submit

September 7, 2018

Conditions

Pancreatitis, Acute Necrotizing

Keywords

Infected pancreatic necrosis

Study Arms (1)

VARD

EXPERIMENTAL

Videoscopic-Assisted Retroperitoneal Debridement (VARD)

Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD)

Interventions

Videoscopic-Assisted Retroperitoneal Debridement (VARD)PROCEDURE
VARD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Veteran's Administration-Portland

Portland, Oregon, 97239, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Veteran's Administration Puget Sound

Seattle, Washington, 98108, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

University of Toronto

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2003

First Posted

May 23, 2003

Study Start

September 1, 2003

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

CA(1)US(5)