Preventing bleeding in liver cancer patients with esophageal varices
Endoscopic Treatment Versus Propranolol for Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices
PHASE4 · Taipei Veterans General Hospital, Taiwan · NCT01970748
This study tests whether a procedure called endoscopic esophageal variceal ligation or a medication called Propranolol is better at preventing bleeding in liver cancer patients with swollen veins in their esophagus.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan (other gov) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT01970748 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of endoscopic esophageal variceal ligation (EVL) versus non-selective beta-blocker (Propranolol) in preventing variceal bleeding in patients with hepatocellular carcinoma (HCC) and esophageal varices. The study aims to address the high rates of rebleeding and mortality associated with gastroesophageal variceal bleeding, particularly in patients with HCC. Participants will be randomized to receive either treatment, and their outcomes will be monitored to determine which method is more effective in reducing the risk of bleeding.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 80 with hepatocellular carcinoma and esophageal varices classified as F2 or F3.
Not a fit: Patients with a history of variceal bleeding or those who have received prior endoscopic treatments will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of life-threatening variceal bleeding in patients with liver cancer.
How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of EVL and NSBB in HCC patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 20 and 80 years old * Hepatocellular carcinoma (HCC) associated with esophageal varices * F2 or F3 esophageal varices (Beppu et al classification) * Hepatocellular carcinoma (HCC) associated with portal thrombosis Exclusion Criteria: * History of esophageal variceal bleeding * Had received endoscopic variceal ligation (EVL) or endoscopic injection sclerotherapy (EIS) * Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...) * Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
Where this trial is running
Taipei
- Taipei Veterans General Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Ming-Chih Hou, MD — Taipei Veterans General Hospital, Taiwan
- Study coordinator: Ming-Chih Hou, MD
- Email: mchou@vghtpe.gov.tw
- Phone: 886-2-28712121
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 Esophageal Varices, Hepatocellular Carcinoma, Variceal bleeding, Portal hypertension, Hepatocellular carcinoma, Endoscopic variceal ligation, Non-selective beta-blocker