BleedingPhase 4NCT00371943
EVL Plus Drug to Prevent Variceal Rebleeding
A Phase 4 study testing band ligation in people with Bleeding, run by National Science and Technology Council, Taiwan at 1 site in Taiwan.
Trial summary
Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal ligation have been proven plausible in the prevention of variceal rebleeding. However, the relative efficacy and safety of the combined treatment for preventing rebleeding remains unresolved. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Bleeding
- What is being tested?
- band ligation
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2001to Mar 2005
- 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
- Acute bleeding from esophageal varices (defined below);
- the etiology of portal hypertension was cirrhosis; and
- age was between 20 and 75 years old. The diagnosis of cirrhosis was based on pathology, clinical, biochemical, and sonographic or computed tomographic findings. Acute esophageal variceal bleeding was defined as when blood was directly seen by endoscopy to issue from an esophageal varix, or when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified.
Who cannot join
- association with hepatocellular carcinoma or other malignancy,
- association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
- had history of gastric variceal bleeding,
- received beta blocker within one month prior to entry,
- had history of contraindication to the use of beta blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate <55/min) or arterial hypotension (systolic blood pressure<90 mmHg).
- had history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt), EIS or EVL,
Show all 11Show fewer
- deep jaundice (serum bilirubin >10mg/dl),
- encephalopathy greater than stage II,
- failure in control of index variceal bleeding,
- death within 24 hours of admission, or
- refused to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Trial of Ligation Plus Drug Vs. Drug Alone in the Prevention of Variceal Rebleeding
Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal ligation have been proven plausible in the prevention of variceal rebleeding. However, the relative efficacy and safety of the combined treatment for preventing rebleeding remains unresolved.
Read the detailed description
Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients still carry a high risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality (1). Therefore, preventive procedures are required in patients surviving an episode of acute variceal bleeding. In recent years, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the management of bleeding esophageal varices (2-3). On the other hand, nonselective beta blockers have been well documented to be effective in reducing variceal rebleeding (4-5). The addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding (6). Some studies showed that the combination of nadolol and ISMN is more effective than EIS or EVL in the reduction of variceal rebleeding (7-8). It is still unknown whether EVL combined with nadolol and ISMN is superior to nadolol and ISMN in the prevention of variceal rebleeding. This study was undertaken to compare the effectiveness and complications of ligation plus nadolol and isosorbide mononitrate vs. nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding.
- Conditions
- Bleeding
- Being tested
- band ligation
- Keywords
- variceal bleeding,band ligation, beta-blocker, had history of esophageal variceal bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
band ligationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
rebleeding rate
Secondary outcomes (1)
complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startJul 2001
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Science and Technology Council, Taiwan
- Sponsor type
- Other government
- Investigators
- Gin Ho Lo, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371943
- Sponsor's protocol ID
- EVL
- Status last verified
- Sep 2006
- First submitted
- 1 Sep 2006
- Last updated
- 15 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Ligation Plus Drug Vs. Drug Alone in the Prevention of Variceal Rebleeding
- ClinicalTrials.gov ID
- NCT00371943
- Acronym / sponsor ID
- EVL
- Conditions
- Bleeding
- Keywords
- variceal bleeding,band ligation, beta-blocker, had history of esophageal variceal bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants
- Lead sponsor
- National Science and Technology Council, TaiwanOther government
- Study start
- Jul 2001
- Study completion
- Mar 2005
- First posted
- 4 Sep 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.
Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal ligation have been proven plausible in the prevention of variceal rebleeding. However, the relative efficacy and safety of the combined treatment for preventing rebleeding remains unresolved.
Detailed description
Bleeding from esophageal varices is a severe complication of portal hypertension. After initial control of acute variceal bleeding, patients still carry a high risk of rebleeding. Of those do rebleed, there is a 20%-35% mortality (1). Therefore, preventive procedures are required in patients surviving an episode of acute variceal bleeding. In recent years, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the management of bleeding esophageal varices (2-3). On the other hand, nonselective beta blockers have been well documented to be effective in reducing variceal rebleeding (4-5). The addition of isosorbide-5-mononitrate (ISMN) has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding (6). Some studies showed that the combination of nadolol and ISMN is more effective than EIS or EVL in the reduction of variceal rebleeding (7-8). It is still unknown whether EVL combined with nadolol and ISMN is superior to nadolol and ISMN in the prevention of variceal rebleeding. This study was undertaken to compare the effectiveness and complications of ligation plus nadolol and isosorbide mononitrate vs. nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute bleeding from esophageal varices (defined below);
- the etiology of portal hypertension was cirrhosis; and
- age was between 20 and 75 years old. The diagnosis of cirrhosis was based on pathology, clinical, biochemical, and sonographic or computed tomographic findings. Acute esophageal variceal bleeding was defined as when blood was directly seen by endoscopy to issue from an esophageal varix, or when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified.
Key exclusion criteria (11 listed)
- association with hepatocellular carcinoma or other malignancy,
- association with cerebral vascular accident, uremia, sepsis or other debilitating disease,
- had history of gastric variceal bleeding,
- received beta blocker within one month prior to entry,
- had history of contraindication to the use of beta blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate <55/min) or arterial hypotension (systolic blood pressure<90 mmHg).
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 |
|---|---|---|
| band ligation | Procedure or surgery | – |
Primary outcome
rebleeding rate
1 secondary outcome
complications
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2006.
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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.
Gin Ho Lo principal investigator
Kaohsiung Veterans General Hospital.
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 band ligation in people with Bleeding, run by National Science and Technology Council, Taiwan 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 11 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 15 Sep 2006. 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. 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?
rebleeding rate. 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 15 Sep 2006.