Comparing cyanoacrylate injection to propranolol for preventing gastric variceal bleeding
Primary Prevention of Gastric Variceal Bleeding : Endoscopic Treatment Versus Non-selective Beta-blocker
PHASE4 · Taipei Veterans General Hospital, Taiwan · NCT01298271
This study is testing whether a new injection treatment or a common medication is better at preventing dangerous bleeding in the stomach for people with liver cirrhosis.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan (other gov) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT01298271 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effectiveness of endoscopic cyanoacrylate injection versus non-selective beta-blocker (propranolol) in preventing gastric variceal bleeding in patients with liver cirrhosis. Gastric varices can lead to severe complications if they rupture, and current treatments for preventing such events are inadequate. The study will enroll patients aged 18 to 80 with liver cirrhosis and assess the outcomes of both interventions. The goal is to determine which method is more effective in preventing the first episode of gastric variceal bleeding.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with liver cirrhosis and evidence of gastric varices.
Not a fit: Patients with previous endoscopic or surgical treatments for varices or those with terminal illnesses affecting major organ systems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the primary prevention strategies for gastric variceal bleeding, potentially reducing morbidity and mortality in affected patients.
How similar studies have performed: While endoscopic cyanoacrylate injection has shown promise in treating acute gastric variceal bleeding, its efficacy in primary prevention is not well established, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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
Where this trial is running
Taipei
- Veteran General Hospital-Taipei — Taipei, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Ming-Chih Hou, MD — National Yang Ming Chiao Tung University
- Study coordinator: Ming-Chih Hou, MD
- Email: mchou@vghtpe.gov.tw
- Phone: 886-2-28712111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bleeding Gastric Varices, Liver Cirrhosis, gastric variceal bleeding, primaryprevention, cyanoacrylate injection, non-selective beta-blocker