Esophageal and Gastric VaricesPhase 3NCT00006161
Decompression Intervention of Variceal Rebleeding Trial (DIVERT)
A Phase 3 study testing Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Distal Splenorenal Shunt in people with Esophageal and Gastric Varices and Liver Cirrhosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 5 sites in United States.
Trial summary
The Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center prospective randomized clinical trial comparing the radiologic procedure of transjugular intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal shunt (DSRS) for variceal bleeding in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal and Gastric Varices, Liver Cirrhosis
- What is being tested?
- Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Distal Splenorenal Shunt
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 1996to Dec 2003
- Phase
- Phase 3
- 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
Who may be able to join
- Variceal bleeding secondary to cirrhosis and portal hypertension
- Child's Class A or B cirrhosis of any etiology
- Patients who have failed endoscopic therapy (sclerotherapy or banding) of varices; or patients who are not candidates for endoscopic therapy
Who cannot join
- Prior shunt procedure
- Portal vein thrombosis
- Polycystic liver disease
- Intractable ascites
- Prior organ transplant
- Any medical intractable disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30322
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Wisconsin
Madison, Wisconsin, 53792
University of Miami School of Medicine
Miami, Florida, 31336
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Decompression Intervention of Variceal Rebleeding Trial
The Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center prospective randomized clinical trial comparing the radiologic procedure of transjugular intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal shunt (DSRS) for variceal bleeding in patients with Child's Class A and B cirrhosis.
This is recognized nationally and internationally as the study that will answer the question as to which of these is the best treatment for decompression of varices in patients who have failed endoscopic and pharmacologic therapy.
- Conditions
- Esophageal and Gastric Varices, Liver Cirrhosis
- Being tested
- Transjugular Intrahepatic Portosystemic Shunt (TIPS), Distal Splenorenal Shunt
- Keywords
- TIPS, DSRS, Varices, Variceal bleeding, Splenorenal Shunt, Transjugular Intrahepatic Portosystemic Shunt, Cirrhosis, Portal hypertension, Liver disease
- Medical subject headings
- Esophageal and Gastric Varices, Liver Cirrhosis, Varicose Veins, Fibrosis, Hypertension, Portal, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular Intrahepatic Portosystemic Shunt (TIPS)Procedure or surgery
Distal Splenorenal ShuntProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2000 (estimated)
- Study startDec 1996
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal and Gastric VaricesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 140 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- J. Michael Henderson, M.D., Principal investigator, The Cleveland ClinicThomas D. Boyer, M.D., Principal investigator, Emory UniversityLennox Jeffers, M.D., Principal investigator, University of MiamiEnrique Molina, M.D., Principal investigator, University of MiamiLayton F. Rikkers, M.D., Principal investigator, University of Wisconsin, MadisonKareem Abu-Elmagd, M.D., Principal investigator, University of Pittsburgh Medical CenterAmrik Shah, Sc.D., Principal investigator, Cleveland Clinic Foundation - Data Coordinating Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006161
- Sponsor's protocol ID
- DIVERT (completed)
- Other IDs
- DK50680-02
- Status last verified
- Jan 2010
- First submitted
- 8 Aug 2000
- Last updated
- 13 Jan 2010
- Results posted
- No
Publications
Boyer TD, Henderson JM, Heerey AM, Arrigain S, Konig V, Connor J, Abu-Elmagd K, Galloway J, Rikkers LF, Jeffers L; DIVERT Study Group. Cost of preventing variceal rebleeding with transjugular intrahepatic portal systemic shunt and distal splenorenal shunt. J Hepatol. 2008 Mar;48(3):407-14. doi: 10.1016/j.jhep.2007.08.014. Epub 2007 Oct 23.
PubMed 18045724
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompression Intervention of Variceal Rebleeding Trial
- ClinicalTrials.gov ID
- NCT00006161
- Acronym / sponsor ID
- DIVERT (completed)
- Conditions
- Esophageal and Gastric Varices, Liver Cirrhosis
- Keywords
- TIPS, DSRS, Varices, Variceal bleeding, Splenorenal Shunt, Transjugular Intrahepatic Portosystemic Shunt, Cirrhosis, Portal hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Dec 1996
- Study completion
- Dec 2003
- First posted
- 9 Aug 2000 (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 Decompression Intervention of Variceal Rebleeding Trial (DIVERT) is a multi-center prospective randomized clinical trial comparing the radiologic procedure of transjugular intrahepatic portal-systemic shunt (TIPS) with the surgical procedure of distal splenorenal shunt (DSRS) for variceal bleeding in patients with Child's Class A and B cirrhosis.
This is recognized nationally and internationally as the study that will answer the question as to which of these is the best treatment for decompression of varices in patients who have failed endoscopic and pharmacologic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Variceal bleeding secondary to cirrhosis and portal hypertension
- Child's Class A or B cirrhosis of any etiology
- Patients who have failed endoscopic therapy (sclerotherapy or banding) of varices; or patients who are not candidates for endoscopic therapy
Key exclusion criteria (6 listed)
- Prior shunt procedure
- Portal vein thrombosis
- Polycystic liver disease
- Intractable ascites
- Prior organ transplant
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 |
|---|---|---|
| Transjugular Intrahepatic Portosystemic Shunt (TIPS) | Procedure or surgery | – |
| Distal Splenorenal Shunt | Procedure or surgery | – |
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 13 Jan 2010.
- Derived from this study: PubMed 18045724Boyer TD, Henderson JM, Heerey AM, Arrigain S, Konig V, Connor J, Abu-Elmagd K, Galloway J, Rikkers LF, Jeffers L; DIVERT Study Group. Cost of preventing variceal rebleeding with transjugular intrahepatic portal systemic shunt and distal splenorenal shunt. J Hepatol. 2008 Mar;48(3):407-14. doi: 10.1016/j.jhep.2007.08.014. Epub 2007 Oct 23.
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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.
J. Michael Henderson, M.D. principal investigator
The Cleveland Clinic
Thomas D. Boyer, M.D. principal investigator
Emory University
Lennox Jeffers, M.D. principal investigator
University of Miami
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Distal Splenorenal Shunt in people with Esophageal and Gastric Varices and Liver Cirrhosis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
On the ClinicalTrials.gov record for NCT00006161, which also lists 1 linked publication.
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 13 Jan 2010.