Clinical trial · Interventional
Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices
Endoscopic Treatment Versus Propranolol for Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices
NCT01970748CI-TRIAL-00040350P-HCCunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Randomized comparison within the endoscopic esophageal varices ligation versus non-selective beta-blocker in the primary prevention of esophageal variceal bleeding in patients with HCC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding Esophageal Varices | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Esophageal variceal ligation | Procedure | — | UNRESOLVED |
| Propranolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Propranolol
- description
- Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate\>55 or systemic blood pressure\>90mmHg)
- interventionNames
- Drug: Propranolol
- type
- ACTIVE_COMPARATOR
- label
- Esophageal variceal ligation
- description
- Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy. After eradication, follow-up endoscopy every 3 months and variceal ligation again if recurrence.
- interventionNames
- Procedure: Esophageal variceal ligation
Primary outcomes (1)
- measure
- Bleeding
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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...)
References
Publications (1)
- DERIVEDYang TC, Chen WC, Hou MC, Chen PH, Lee PC, Chang CY, Lu HS, Chen YJ, Hsu SJ, Huang HC, Luo JC, Huang YH, Lee FY. Endoscopic variceal ligation versus propranolol for the primary prevention of oesophageal variceal bleeding in patients with hepatocellular carcinoma: an open-label, two-centre, randomised controlled trial. Gut. 2024 Mar 7;73(4):682-690. doi: 10.1136/gutjnl-2023-330419. PMID 38123994