CirrhosisPhase 4NCT00966121
Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding
A Phase 4 study testing endoscopic band ligation and EBL+Propranolol in people with Cirrhosis and Variceal Bleeding, run by Korea University at 1 site in South Korea.
Trial summary
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. 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 EBL+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
- 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 Variceal Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding
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. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of endoscopic variceal treatment.
- Conditions
- Cirrhosis, Variceal Bleeding
- Being tested
- endoscopic band ligation, EBL+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 within 7 days after randomization
- Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (at 4,8,12 weeks after initial treatment).
- Acid suppression using proton pump inhibitor until eradicated.
- After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months).
EBL+PropranololProcedure or surgery
- Start with 20 mg b.i.d
- Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min
- After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic band ligation | Active comparator | Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval Receives: Procedure: endoscopic band ligation |
| EBL+Propranolol | Active comparator | Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min Receives: Procedure: EBL+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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966121
- Sponsor's protocol ID
- EBLPPL-1
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2009
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Comparing the Efficacies of Endoscopic Variceal Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding
- ClinicalTrials.gov ID
- NCT00966121
- Acronym / sponsor ID
- EBLPPL-1
- 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.
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. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of 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 esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval |
| EBL+Propranolol | Active comparator | Procedure: EBL+PropranololPerform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min |
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 ligation* Perform EBL within 7 days after randomization * Apply 1-2 band/column/session to varices in the distal 5-7cm of the esophagus till they are eradicated (Disappearance or too small to apply band) with interval of 4weeks (at 4,8,12 weeks after initial treatment). * Acid suppression using proton pump inhibitor until eradicated. * After eradication, then follow-up endoscopy according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3-6 months until 36 months). | Procedure or surgery | Endoscopic band ligation |
| EBL+Propranolol* Start with 20 mg b.i.d * Adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min * After reaching target HR, then FU according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months) | Procedure or surgery | EBL+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 23 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.
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 EBL+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 23 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 23 Aug 2017.