CirrhosisPhase 4NCT00966082
EBL Versus EBL and Propranolol for the Prevention of Variceal Rebleeding in Pts With Previous Variceal Treatment
A Phase 4 study testing endoscopic band ligation and endoscopic band ligation+Propranolol in people with Cirrhosis and Variceal Bleeding, run by Korea University at 1 site in South Korea.
Trial summary
This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Variceal Bleeding
- What is being tested?
- endoscopic band ligation and endoscopic band ligation+Propranolol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2008to Jul 2021
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver cirrhosis
- Age between 18 and 70 years
- Successful control of esophageal variceal bleeding within 6 weeks before enrollment
Who cannot join
- Gastric variceal bleeding
- Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
- Portal vein thrombosis
- Prominent hepatic encephalopathy
- Coexisting untreated malignancy
- Severe cerebrovascular or cardiovascular disease, renal failure
Show all 10Show fewer
- No previous history of endoscopic, radiologic, or surgical treatment for varices or ascites
- Contraindication to beta-blocker
- Pregnancy
- Refusal to give consent to participate in the trial
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, 136-705
About this study
Official title: RCT Comparing the Efficacies of Endoscopic Band Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding in Patients With Previous Endoscopic Variceal Treatment
This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.
Read the detailed description
Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.
- Conditions
- Cirrhosis, Variceal Bleeding
- Being tested
- endoscopic band ligation, endoscopic band ligation+Propranolol
- Keywords
- Cirrhosis, Esophagus Disorders, Varicose Veins
- Medical subject headings
- Fibrosis, Esophageal Diseases, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic band ligationProcedure or surgery
Perform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
endoscopic band ligation+PropranololProcedure or surgery
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic band ligation | Active comparator | Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval Receives: Procedure: endoscopic band ligation |
| endoscopic band ligation+Propranolol | Active comparator | Perform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval, with propranolol Receives: Procedure: endoscopic band ligation+Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding from esophageal varices
Rebleeding from esophageal varices
Measured: 2 years
Secondary outcomes (1)
Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events
Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startAug 2008
- Primary completionJul 2019 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Model description
- Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Ho Um, Korea University
- Investigators
- Soon Ho Um, Prof, Principal investigator, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966082
- Sponsor's protocol ID
- EBLPPL-2
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2009
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Comparing the Efficacies of Endoscopic Band Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding in Patients With Previous Endoscopic Variceal Treatment
- ClinicalTrials.gov ID
- NCT00966082
- Acronym / sponsor ID
- EBLPPL-2
- Conditions
- Cirrhosis, Variceal Bleeding
- Keywords
- Cirrhosis, Esophagus Disorders, Varicose Veins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 26 Aug 2009 (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.
This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.
Detailed description
Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. In addition, most of all recent studies included patients without previous endoscopic treatment for varices. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients who were previously performed endoscopic variceal treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol
| Arm | Type | Receives |
|---|---|---|
| Endoscopic band ligation | Active comparator | Procedure: endoscopic band ligationPerform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval |
| endoscopic band ligation+Propranolol | Active comparator | Procedure: endoscopic band ligation+PropranololPerform endoscopic band ligation (EBL) until eradication of esophageal varices, and then follow-up endoscopy with 3-6 months interval, with propranolol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Liver cirrhosis
- Age between 18 and 70 years
- Successful control of esophageal variceal bleeding within 6 weeks before enrollment
Key exclusion criteria (10 listed)
- Gastric variceal bleeding
- Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
- Portal vein thrombosis
- Prominent hepatic encephalopathy
- Coexisting untreated malignancy
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 band ligationPerform EBL until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval | Procedure or surgery | Endoscopic band ligation |
| endoscopic band ligation+PropranololPerform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min | Procedure or surgery | endoscopic band ligation+Propranolol |
Primary outcome
Rebleeding from esophageal varices
Time frame: 2 years
Rebleeding from esophageal varices
1 secondary outcome
Upper gastrointestinal bleeding; Significant esophageal variceal bleeding; Mortality; Adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
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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.
Soon Ho Um, Prof principal investigator
Korea University
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 endoscopic band ligation and endoscopic band ligation+Propranolol in people with Cirrhosis and Variceal Bleeding, run by Korea University at 1 site in South Korea.
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 10 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soon Ho Um, Prof (82-2-920-5019, umsh@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding from esophageal varices (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 22 Aug 2017.