Videoendoscopic Drainage of Infected Pancreatic Collections

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.

Study Overview

• Status: Completed
• Conditions: Pancreatitis, Acute Necrotizing
• Intervention / Treatment: Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • University of Toronto
• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University
    • Portland, Oregon, United States, 97239
      • Veteran's Administration-Portland
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98195
      • University of Washington
    • Seattle, Washington, United States, 98108
      • Veteran's Administration Puget Sound

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VARD; Videoscopic-Assisted Retroperitoneal Debridement (VARD)	Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD)

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2003
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: May 22, 2003
• First Submitted That Met QC Criteria: May 22, 2003
• First Posted (Estimate): May 23, 2003

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Infected pancreatic necrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Acute Necrotizing
• Other Study ID Numbers: VDIPC (completed); R03DK061362 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No