Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices

Trial Title: Primary Prevention of Patients With Hepatocellular Carcinoma and Concomitant Esophageal Varices

NCT ID: NCT01970748

Condition: Bleeding Esophageal Varices
Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Esophageal and Gastric Varices
Varicose Veins
Propranolol

Conditions: Keywords:
Variceal bleeding
Portal hypertension
Hepatocellular carcinoma
Endoscopic variceal ligation
Non-selective beta-blocker

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 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)
Arm group label: Propranolol

Other name: Inderal, Cardolol

Intervention type: Procedure
Intervention name: Esophageal variceal ligation
Description: Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy
Arm group label: Esophageal variceal ligation

Other name: EVL

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.

Criteria for eligibility:
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...)

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Taipei Veterans General Hospital

Address:
City: Taipei
Zip: 11217
Country: Taiwan

Status: Recruiting

Contact:
Last name: Ming-Chih Hou, MD

Phone: 886-2-28712121

Phone ext: 1320
Email: mchou@vghtpe.gov.tw

Contact backup:
Last name: Han-Chieh Lin, MD

Phone: 886-2-28712121

Phone ext: 7506
Email: hclin@vghtpe.gov.tw

Investigator:
Last name: Ming-Chih Hou, MD
Email: Principal Investigator

Start date: August 2009

Completion date: December 31, 2025

Lead sponsor:
Agency: Taipei Veterans General Hospital, Taiwan
Agency class: Other

Source: Taipei Veterans General Hospital, Taiwan

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01970748