Esophageal VaricesPhase 3NCT00409084
Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding
A Phase 3 study testing endoscopic variceal band ligation in people with Esophageal Varices, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Varices
- What is being tested?
- endoscopic variceal band ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jun 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cirrhosis
- medium to large varices
Who cannot join
- contraindications to beta blockers
- refusal to give consent
- prior history of variceal hemorrhage
- creatinine > 1.5 mg/dl
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Current recommendations are to prevent bleeding of medium or large varices (when there is no history of bleeding) by starting a blood pressure lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation). Using both therapies at the same time has not been studied. In this study, we hope to determine if the use of combination therapy with endoscopic variceal band ligation and beta blockers is more effective than using beta blockers alone to prevent the first bleeding episode from the varices (dilated veins). The efficacy, ability to tolerate, and cost-effectiveness of these two treatment strategies will be compared.
- Conditions
- Esophageal Varices
- Being tested
- endoscopic variceal band ligation
- Keywords
- varices, band ligation, portal hypertension, primary prophylaxis, cirrhosis, beta blockers
- Medical subject headings
- Esophageal and Gastric Varices, Varicose Veins, Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic variceal band ligationProcedure or surgery
endoscopic variceal band ligation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | endoscopic variceal band ligation Receives: Procedure: endoscopic variceal band ligation |
| 2 | Active comparator | subjects will receive nadolol (beta blocker) at 20mg/day with dose titration Receives: Procedure: endoscopic variceal band ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
first variceal bleed
Measured: 2 years
Secondary outcomes (7)
survival
Measured: 2 years
liver function
Measured: 1 year
encephalopathy
Measured: 1 year
quality of life
Measured: 1 year
frequency of other complications of cirrhosis
Measured: 2 years
cost utility
Measured: 1 year
patient preference
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Investigators
- Arun J Sanyal, M.D., Principal investigator, Division of Gastroenterology, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409084
- Sponsor's protocol ID
- HM10546
- Status last verified
- Jul 2010
- First submitted
- 6 Dec 2006
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding
- ClinicalTrials.gov ID
- NCT00409084
- Acronym / sponsor ID
- HM10546
- Conditions
- Esophageal Varices
- Keywords
- varices, band ligation, portal hypertension, primary prophylaxis, cirrhosis, beta blockers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Dec 2006 (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.
Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Current recommendations are to prevent bleeding of medium or large varices (when there is no history of bleeding) by starting a blood pressure lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation). Using both therapies at the same time has not been studied. In this study, we hope to determine if the use of combination therapy with endoscopic variceal band ligation and beta blockers is more effective than using beta blockers alone to prevent the first bleeding episode from the varices (dilated veins). The efficacy, ability to tolerate, and cost-effectiveness of these two treatment strategies will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: endoscopic variceal band ligationendoscopic variceal band ligation |
| 2 | Active comparator | Procedure: endoscopic variceal band ligationsubjects will receive nadolol (beta blocker) at 20mg/day with dose titration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cirrhosis
- medium to large varices
Key exclusion criteria (4 listed)
- contraindications to beta blockers
- refusal to give consent
- prior history of variceal hemorrhage
- creatinine > 1.5 mg/dl
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 |
|---|---|---|
| endoscopic variceal band ligationendoscopic variceal band ligation | Procedure or surgery | 1, 2 |
Primary outcome
first variceal bleed
Time frame: 2 years
7 secondary outcomes
survival
Time frame: 2 years
liver function
Time frame: 1 year
encephalopathy
Time frame: 1 year
quality of life
Time frame: 1 year
frequency of other complications of cirrhosis
Time frame: 2 years
cost utility
Time frame: 1 year
patient preference
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
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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.
Arun J Sanyal, M.D. principal investigator
Division of Gastroenterology, Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing endoscopic variceal band ligation in people with Esophageal Varices, run by Virginia Commonwealth University at 1 site 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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.
What does the primary outcome measure?
first variceal bleed (time frame: 2 years). It is what the study was designed to measure, not a finding.
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 5 Jul 2010.