Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices

Hepatocellular Carcinoma Clinical Trial

— P-HCC  

Official title:

Endoscopic Treatment Versus Propranolol for Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01970748
• Other study ID #: V101C-016;V102C-094
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ming-Chih Hou, MD
• Phone: 886-2-28712121
• Email: mchou[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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...)

Related Conditions & MeSH terms

• Bleeding Esophageal Varices
• Carcinoma
• Carcinoma, Hepatocellular
• Esophageal and Gastric Varices
• Hemorrhage
• Hepatocellular Carcinoma
• Varicose Veins

Intervention

Drug:
• Propranolol
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)

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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding		2 years
Secondary	Complication survival		2 years