Pancreatitis, Acute NecrotizingNCT00061269
Videoendoscopic Drainage of Infected Pancreatic Collections
A study testing Videoscopic-Assisted Retroperitoneal Debridement (VARD) in people with Pancreatitis, Acute Necrotizing, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Acute Necrotizing
- What is being tested?
- Videoscopic-Assisted Retroperitoneal Debridement (VARD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Sep 2003to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Oregon Health Sciences University
Portland, Oregon, 97239
Veteran's Administration-Portland
Portland, Oregon, 97239
Harborview Medical Center
Seattle, Washington, 98104
Veteran's Administration Puget Sound
Seattle, Washington, 98108
University of Washington
Seattle, Washington, 98195
About this study
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.
- Conditions
- Pancreatitis, Acute Necrotizing
- Being tested
- Videoscopic-Assisted Retroperitoneal Debridement (VARD)
- Keywords
- Infected pancreatic necrosis
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videoscopic-Assisted Retroperitoneal Debridement (VARD)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| VARD | Experimental | Videoscopic-Assisted Retroperitoneal Debridement (VARD) Receives: Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2003 (estimated)
- Study startSep 2003
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, Acute NecrotizingStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061269
- Sponsor's protocol ID
- VDIPC (completed)
- Other IDs
- R03DK061362
- Status last verified
- Sep 2018
- First submitted
- 22 May 2003
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videoendoscopic Drainage of Infected Pancreatic Collections
- ClinicalTrials.gov ID
- NCT00061269
- Acronym / sponsor ID
- VDIPC (completed)
- Conditions
- Pancreatitis, Acute Necrotizing
- Keywords
- Infected pancreatic necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 2003 (actual)
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VARD | Experimental | Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD)Videoscopic-Assisted Retroperitoneal Debridement (VARD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videoscopic-Assisted Retroperitoneal Debridement (VARD) | Procedure or surgery | VARD |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videoscopic-Assisted Retroperitoneal Debridement (VARD) in people with Pancreatitis, Acute Necrotizing, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.