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CompletedNCT01298271P-GVOUpdated Aug 18, 2026

A Randomized Trial of GVS Alone vs. Propranolol

A Phase 4 interventional study of propranolol in Bleeding Gastric Varices and Liver Cirrhosis, sponsored by Taipei Veterans General Hospital, Taiwan. Completed at 2 sites in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Taipei Veterans General Hospital, Taiwan · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bleeding Gastric Varices
  • Liver Cirrhosis

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Keywords

  • gastric variceal bleeding
  • primaryprevention
  • cyanoacrylate injection
  • non-selective beta-blocker
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 120 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. patients with live cirrhosis and/or hepatoma
  2. Aged 18 to 80, who had endoscopy-Proven EV(-)GV(+)or EV\<GV

Exclusion criteria

Exclusion Criteria:

  1. Patients had previous endoscopic, surgical treatment or Transjugular Intrahepatic Portosystemic Shunt
  2. Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
120 participants (actual)

Study arms

  • No intervention
    Cyanoacrylate

    Endoscopic Cyanoacrylate Injection treatment of primary prevention GVB

  • Active comparator
    Propranolol

    Propranolol is used for primary prevention of GVB

    Drug: propranolol

Interventions

  • Drugpropranolol

    Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

    Also known as: Inderal, Cardolol

06

What researchers measure

Primary outcomes

  1. gastric variceal bleeding

    first bleeding of gastric varices

    Time frame: 5 year

Secondary outcomes

  1. complication surivial

    Time frame: 3 year

07

Study locations

2 sites
  • Veteran General Hospital-Taipei
    Taipei, Taiwan 11217, Taiwan
  • Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
    Kaohsiung City, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01298271
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
Feb 17, 2011
Start date
Apr 2010
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Aug 18, 2026

Study contacts

Ming-Chih Hou, MD
principal investigator · National Yang Ming Chiao Tung University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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