Bleeding Gastric VaricesPhase 4P-GVONCT01298271
A Randomized Trial of GVS Alone vs. Propranolol
A Phase 4 study testing propranolol in people with Bleeding Gastric Varices and Liver Cirrhosis, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
Trial summary
Design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bleeding Gastric Varices, Liver Cirrhosis
- What is being tested?
- propranolol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- Apr 2010to 31 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with live cirrhosis and/or hepatoma
- Aged 18 to 80, who had endoscopy-Proven EV(-)GV(+)or EV<GV
Who cannot join
- Patients had previous endoscopic, surgical treatment or Transjugular Intrahepatic Portosystemic Shunt
- Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
Kaohsiung City
Veteran General Hospital-Taipei
Taipei, Taiwan, 11217
About this study
Official title: Primary Prevention of Gastric Variceal Bleeding : Endoscopic Treatment Versus Non-selective Beta-blocker
Design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal bleeding.
Read the detailed description
Up to date, the treatment of gastric variceal bleeding (GVB) is still sub-optimal in contrast to the treatment of esophageal variceal bleeding (EVB), which already had a big improvement of prognosis in recent two decades. Gastric varices (GV) rarely rupture. However should it occur, the outcome would be worse than rupture of esophageal varies (EV). Rupture of GV is characteristic of a higher rebleeding rate (90%), a requirement for a larger amount of blood transfusion and a higher mortality (40-50%). Therefore, primary prevention of GV rupture is critically important. The management of GV has been focused on treatment of acute GVB. Tissue adhesive (cyanoacrylate) may polymerize and occlude the vascular channels in seconds and obliterate for more than 70% cases of GV. The rebleeding rate after endoscopic cyanoacrylate injection(GVO) of acute GVB is around 30~40% and expertise is required to reduce the embolic complications and instrumental injuries.GVO may arrest more than 90% active GVB. The 2005 Baveno IV International Consensus and 2007 AASLD Guidelines endorsed that endoscopic cyanoacrylate injection is the first line treatment for acute GVB. However, its efficacy on prevention of first GV bleeding is not known. Non-selective beta-blocker (NSBB) is effective to prevent first and second bleeding from esophageal varices. The 2005 Baveno IV International Consensus and 2007 AASLD Guidelines also endorsed that NSBB is the first choice for the primary prevention of EVB. However, its effect on gastric variceal hemorrhage has never been clarified. Actually, GV usually has a large gastrorenal shunting and the portal pressure of GV is lower than that of EV. For ethical concerns, NSBB is usually be used for primary prevention of GVB, the preventive effect of NSBB had never been proved. Study on the primary prevention of GVB is scanty. This is an important issue prompted by current portal hypertension experts. The investigators have a lot of experience in the treatment of gastric variceal bleeding and published fruitful results in high ranking journals. Therefore, the investigators design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal bleeding.
- Conditions
- Bleeding Gastric Varices, Liver Cirrhosis
- Being tested
- propranolol
- Keywords
- gastric variceal bleeding, primaryprevention, cyanoacrylate injection, non-selective beta-blocker
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
Also called Inderal, Cardolol
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
| Study group | Role | What they receive |
|---|---|---|
| Cyanoacrylate | No intervention | Endoscopic Cyanoacrylate Injection treatment of primary prevention GVB |
| Propranolol | Active comparator | Propranolol is used for primary prevention of GVB Receives: Drug: propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric variceal bleeding
first bleeding of gastric varices
Measured: 5 year
Secondary outcomes (1)
complication surivial
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startApr 2010
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding Gastric VaricesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ming-Chih Hou, MD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298271
- Sponsor's protocol ID
- NSC99-2314-B-010-049-MY3
- Acronym
- P-GVO
- Status last verified
- Aug 2026
- First submitted
- 4 Oct 2010
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Gastric Variceal Bleeding : Endoscopic Treatment Versus Non-selective Beta-blocker
- ClinicalTrials.gov ID
- NCT01298271
- Acronym / sponsor ID
- P-GVO / NSC99-2314-B-010-049-MY3
- Conditions
- Bleeding Gastric Varices, Liver Cirrhosis
- Keywords
- gastric variceal bleeding, primaryprevention, cyanoacrylate injection, non-selective beta-blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Apr 2010
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Feb 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.
Design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal bleeding.
Detailed description
Up to date, the treatment of gastric variceal bleeding (GVB) is still sub-optimal in contrast to the treatment of esophageal variceal bleeding (EVB), which already had a big improvement of prognosis in recent two decades. Gastric varices (GV) rarely rupture. However should it occur, the outcome would be worse than rupture of esophageal varies (EV). Rupture of GV is characteristic of a higher rebleeding rate (90%), a requirement for a larger amount of blood transfusion and a higher mortality (40-50%). Therefore, primary prevention of GV rupture is critically important. The management of GV has been focused on treatment of acute GVB. Tissue adhesive (cyanoacrylate) may polymerize and occlude the vascular channels in seconds and obliterate for more than 70% cases of GV. The rebleeding rate after endoscopic cyanoacrylate injection(GVO) of acute GVB is around 30~40% and expertise is required to reduce the embolic complications and instrumental injuries.GVO may arrest more than 90% active GVB. The 2005 Baveno IV International Consensus and 2007 AASLD Guidelines endorsed that endoscopic cyanoacrylate injection is the first line treatment for acute GVB. However, its efficacy on prevention of first GV bleeding is not known. Non-selective beta-blocker (NSBB) is effective to prevent first and second bleeding from esophageal varices. The 2005 Baveno IV International Consensus and 2007 AASLD Guidelines also endorsed that NSBB is the first choice for the primary prevention of EVB. However, its effect on gastric variceal hemorrhage has never been clarified. Actually, GV usually has a large gastrorenal shunting and the portal pressure of GV is lower than that of EV. For ethical concerns, NSBB is usually be used for primary prevention of GVB, the preventive effect of NSBB had never been proved. Study on the primary prevention of GVB is scanty. This is an important issue prompted by current portal hypertension experts. The investigators have a lot of experience in the treatment of gastric variceal bleeding and published fruitful results in high ranking journals. Therefore, the investigators design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyanoacrylate | No intervention | –Endoscopic Cyanoacrylate Injection treatment of primary prevention GVB |
| Propranolol | Active comparator | Drug: propranololPropranolol is used for primary prevention of GVB |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with live cirrhosis and/or hepatoma
- Aged 18 to 80, who had endoscopy-Proven EV(-)GV(+)or EV<GV
Key exclusion criteria (2 listed)
- Patients had previous endoscopic, surgical treatment or Transjugular Intrahepatic Portosystemic Shunt
- Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
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 |
|---|---|---|
| propranololAlso: Inderal, CardololStarting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period | Drug | Propranolol |
Primary outcome
gastric variceal bleeding
Time frame: 5 year
first bleeding of gastric varices
1 secondary outcome
complication surivial
Time frame: 3 year
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 18 Aug 2026.
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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.
Ming-Chih Hou, MD principal investigator
National Yang Ming Chiao Tung University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propranolol in people with Bleeding Gastric Varices and Liver Cirrhosis, run by Taipei Veterans General Hospital, Taiwan at 2 sites 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 2 inclusion and 2 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
gastric variceal bleeding (time frame: 5 year). 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 18 Aug 2026.