Variceal BleedingPhase 4NCT01383044
Banding Ligation With Carvedilol Versus Carvedilol for the Prevention of First Bleeding
A Phase 4 study testing EVL + carvedilol and carvedilol in people with Variceal Bleeding, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy \& safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Variceal Bleeding
- What is being tested?
- EVL + carvedilol and carvedilol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2011to 30 Jun 2020
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis with esophageal varices are larger than F2.
- No history of variceal bleeding.
- In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs.
Who cannot join
- Association with HCC or other cancers .
- Refractory ascites.
- Jaundice, bilirubin > 5mg/dl.
- Encephalopathy.
- Cr.>3mg/dL.
- A-V,block bradycardia (PR < 60/mim).
Show all 15Show fewer
- Hypotension systolic blood pressure<95/mmHg .
- Refusal to participate.
- Carvedilol allergy
- Second degree-third degree Atrio-ventricular block.
- Bradycardia.
- WPWsyndrome
- Hypotension
- Psychogenic shock.
- Asthma. All the patients are randomized based on a random number.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices
Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy \& safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.
Read the detailed description
Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.
- Conditions
- Variceal Bleeding
- Being tested
- EVL + carvedilol, carvedilol
- Keywords
- Carvedilol, Banding ligation with Carvedilol, the efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVL + carvedilolProcedure or surgery
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
carvedilolDrug
carvedilol 6.25mg-12.5 mg per day
| Study group | Role | What they receive |
|---|---|---|
| EVL + carvedilol | Experimental | EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day Receives: Procedure: EVL + carvedilol |
| carvedilol | Active comparator | carvedilol 6.25-12.5 mg per day Receives: Drug: carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients with first bleeding
the difference of bleeding episode in both groups.
Measured: 3 years
Secondary outcomes (1)
patients with complications and mortality rates
the difference of complications \& survival curve between both groups.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study start8 Jul 2011
- Primary completion30 Jul 2015
- Study completion30 Jun 2020
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Variceal BleedingStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383044
- Sponsor's protocol ID
- Carvedilol
- Status last verified
- Nov 2020
- First submitted
- 16 Jun 2011
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices
- ClinicalTrials.gov ID
- NCT01383044
- Acronym / sponsor ID
- Carvedilol
- Conditions
- Variceal Bleeding
- Keywords
- Carvedilol, Banding ligation with Carvedilol, the efficacy & safety of combining EVL and carvedilol in prevention of first variceal bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 65 participants (actual)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 8 Jul 2011 (actual)
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Jun 2011 (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.
Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy \& safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.
Detailed description
Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVL + carvedilol | Experimental | Procedure: EVL + carvedilolEVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day |
| carvedilol | Active comparator | Drug: carvedilolcarvedilol 6.25-12.5 mg per day |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cirrhosis with esophageal varices are larger than F2.
- No history of variceal bleeding.
- In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs.
Key exclusion criteria (15 listed)
- Association with HCC or other cancers .
- Refractory ascites.
- Jaundice, bilirubin > 5mg/dl.
- Encephalopathy.
- Cr.>3mg/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 |
|---|---|---|
| EVL + carvedilolEVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day | Procedure or surgery | EVL + carvedilol |
| carvedilolcarvedilol 6.25mg-12.5 mg per day | Drug | carvedilol |
Primary outcome
patients with first bleeding
Time frame: 3 years
the difference of bleeding episode in both groups.
1 secondary outcome
patients with complications and mortality rates
Time frame: 3 years
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EVL + carvedilol and carvedilol in people with Variceal Bleeding, run by E-DA Hospital at 1 site in Taiwan.
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 15 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 20 Nov 2020. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: slow 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?
patients with first bleeding (time frame: 3 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 20 Nov 2020.