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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01970748
Acronym
P-HCC
Enrollment
200
Registered
2013-10-28
Start date
2009-08-31
Completion date
2025-12-31
Last updated
2019-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Esophageal Varices, Hepatocellular Carcinoma

Keywords

Variceal bleeding, Portal hypertension, Hepatocellular carcinoma, Endoscopic variceal ligation, Non-selective beta-blocker

Brief summary

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.

Detailed description

Gastroesophageal variceal bleeding is a major complication of cirrhosis and has high rate of rebleeding and mortality. In these 20 to 30 years, medical advances have significantly improved the prognosis of variceal bleeding. Nevertheless, the mortality of gastroesophageal variceal bleeding is still nearly 20 to 30%. Hepatocellular carcinoma (HCC) is one of the most common malignancy in Asian, and is also the special group in portal hypertension. Studies in Italy, more than 50% of patients diagnosed with HCC are concomitant with esophageal varices. HCC and portal thrombosis caused by HCC itself are all independent risk factors of gastroesophageal bleeding. Once the bleeding, rebleeding rate is up to 50% even if early use of vasoconstrictor agents and endoscopic therapy, which is generally 2 times in patients with cirrhosis. According to 2010 Baveno V recommendations, non-selective beta-blockers (NSBB) or endoscopic variceal ligation (EVL) are first choice for primary prevention of first variceal bleeding in cirrhotic patients. However, risk factors of variceal bleeding caused by HCC or cirrhosis are different, and portal hypertension is particularly high in patients with HCC and may be combined with portal vein thrombosis. NSBB sufficient to decreased portal hypertension to prevent variceal bleeding is not clear. In Hepatology 2010, Lebrec claimed that NSBB used for cirrhotic patients with refractory ascites had poor prognosis, the main cause of death were the progression of HCC and sepsis, although the impact of NSBB for HCC patients are not entirely clear, but this issue remind clinicians to careful use of NSBB in these patients. Since NSBB possible adverse effects, the use of EVL to prevent bleeding in patents with HCC is superior to NSBB? These need further study to clarify. So we designed this study to evaluate the feasibility and effectiveness of using EVL or NSBB to prevent first bleeding in patients with HCC concomitant with esophageal varices.

Interventions

DRUGPropranolol

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)

PROCEDUREEsophageal variceal ligation

Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frame
Bleeding2 years

Secondary

MeasureTime frame
Complication survival2 years

Countries

Taiwan

Contacts

Primary ContactMing-Chih Hou, MD
mchou@vghtpe.gov.tw886-2-28712121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026