Gastric Variceal HemorrhagePhase 3NCT00292331
N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage
A Phase 3 study testing cyanoacrylate injection to treat gastric variceal hemorrhage in people with Gastric Variceal Hemorrhage, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The purpose of this study was to test the hypothesis by comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute GVH in liver cirrhotic patients with or without concomitant hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Variceal Hemorrhage
- What is being tested?
- cyanoacrylate injection to treat gastric variceal hemorrhage
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Start not givento not given
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were aged between 18 and 80 years and had endoscopy-proven acute gastric variceal hemorrhage (GVH)
Who cannot join
- Cases with concomitant large GV and large EV, but without stigmata of recent bleeding
- Cases had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt for GVH
- Cases had a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or nonhepatic malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Endoscopic Treatment of Acute Gastric Variceal Hemorrhage: N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation
The purpose of this study was to test the hypothesis by comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute GVH in liver cirrhotic patients with or without concomitant hepatocellular carcinoma (HCC).
Read the detailed description
Gastric variceal hemorrhage (GVH) has a poorer prognosis than esophageal variceal hemorrhage. However, data on its optimal treatment are limited. We designed a prospective study to compare the efficacy of endoscopic band ligation (GVL) and endoscopic N-butyl-2-cyanoacrylate injection (GVO). Liver cirrhotic patients with or without concomitant hepatocelluar carcinoma (HCC) and patients presenting with acute GVH were randomized into two treatment groups. Forty-eight patients received GVL, and another 49 patients received GVO. Both treatments were equally successful in controlling active bleeding (14/15 vs. 14/15, P = 1.000). More of the patients who underwent GVL had GV rebleeding (GVL vs. GVO, 21/48 vs. 11/49; P = .044). The 2-year and 3-year cumulative rate of GV rebleeding were 63.1% (95% confidence interval [CI], 44.5%-81.7%), 72.3% (95% CI, 51.3%-93.3%) for GVL and 26.8% (95% CI, 12.5%-41.1%), 26.8% (95% CI, 12.5%-41.1%) for GVO; P = .0143, log-rank test. The rebleeding risk of GVL sustained throughout the entire follow-up period. Multivariate Cox regression indicated that concomitance with HCC (relative hazard: 2.453, 95% CI: 1.036-5.806, P = .041) and the treatment method (GVL vs. GVO, relative hazard: 2.660, 95% CI: 1.167-6.061, P = .020) were independent factors predictive of GV rebleeding. There was no difference in survival between the two groups. Severe complications due to these two treatments were rare. In conclusion, the efficacy of GVL to control active GVH appears to have no difference with GVO, but GVO is associated with a lower GV rebleeding rate.
- Conditions
- Gastric Variceal Hemorrhage
- Being tested
- cyanoacrylate injection to treat gastric variceal hemorrhage
- Keywords
- gastric varices, liver cirrhosis, hepatocelluar carcinoma, rebleeding, long-term
- Medical subject headings
- Esophageal and Gastric Varices, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyanoacrylate injection to treat gastric variceal hemorrhageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute gastric variceal hemorrhage (GVH) in liver cirrhotic patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Variceal HemorrhageStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Investigators
- Ming-Chih Hou, M.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292331
- Sponsor's protocol ID
- VGH-88-B251
- Status last verified
- Feb 2006
- First submitted
- 14 Feb 2006
- Last updated
- 15 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Endoscopic Treatment of Acute Gastric Variceal Hemorrhage: N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation
- ClinicalTrials.gov ID
- NCT00292331
- Acronym / sponsor ID
- VGH-88-B251
- Conditions
- Gastric Variceal Hemorrhage
- Keywords
- gastric varices, liver cirrhosis, hepatocelluar carcinoma, rebleeding, long-term
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- First posted
- 15 Feb 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.
The purpose of this study was to test the hypothesis by comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute GVH in liver cirrhotic patients with or without concomitant hepatocellular carcinoma (HCC).
Detailed description
Gastric variceal hemorrhage (GVH) has a poorer prognosis than esophageal variceal hemorrhage. However, data on its optimal treatment are limited. We designed a prospective study to compare the efficacy of endoscopic band ligation (GVL) and endoscopic N-butyl-2-cyanoacrylate injection (GVO). Liver cirrhotic patients with or without concomitant hepatocelluar carcinoma (HCC) and patients presenting with acute GVH were randomized into two treatment groups. Forty-eight patients received GVL, and another 49 patients received GVO. Both treatments were equally successful in controlling active bleeding (14/15 vs. 14/15, P = 1.000). More of the patients who underwent GVL had GV rebleeding (GVL vs. GVO, 21/48 vs. 11/49; P = .044). The 2-year and 3-year cumulative rate of GV rebleeding were 63.1% (95% confidence interval [CI], 44.5%-81.7%), 72.3% (95% CI, 51.3%-93.3%) for GVL and 26.8% (95% CI, 12.5%-41.1%), 26.8% (95% CI, 12.5%-41.1%) for GVO; P = .0143, log-rank test. The rebleeding risk of GVL sustained throughout the entire follow-up period. Multivariate Cox regression indicated that concomitance with HCC (relative hazard: 2.453, 95% CI: 1.036-5.806, P = .041) and the treatment method (GVL vs. GVO, relative hazard: 2.660, 95% CI: 1.167-6.061, P = .020) were independent factors predictive of GV rebleeding. There was no difference in survival between the two groups. Severe complications due to these two treatments were rare. In conclusion, the efficacy of GVL to control active GVH appears to have no difference with GVO, but GVO is associated with a lower GV rebleeding rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were aged between 18 and 80 years and had endoscopy-proven acute gastric variceal hemorrhage (GVH)
Key exclusion criteria (3 listed)
- Cases with concomitant large GV and large EV, but without stigmata of recent bleeding
- Cases had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt for GVH
- Cases had a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or nonhepatic 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 |
|---|---|---|
| cyanoacrylate injection to treat gastric variceal hemorrhage | Procedure or surgery | – |
Primary outcome
Comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute gastric variceal hemorrhage (GVH) in liver cirrhotic patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2006.
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Cirrhosis, Liver, Portal Hypertension
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.
Ming-Chih Hou, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
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 cyanoacrylate injection to treat gastric variceal hemorrhage in people with Gastric Variceal Hemorrhage, run by Taipei Veterans General Hospital, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 15 Feb 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute gastric variceal hemorrhage (GVH) in liver cirrhotic patients. 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 Feb 2006.