NCT01451658

A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol (S-HCC)

Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patients with hepatocellular carcinoma and esophageal varices bleeding were randomized to undergo endoscopic ligation alone (group A) and additive propranolol treatment (group B) after stabilization of their first acute bleeding.

Detailed description

Esophageal variceal bleeding is characteristic of high rebleeding rate and mortality. Thanks to the recent advance of treatment for variceal bleeding such as non-selective beta blocker (NSBB) added to endoscopic ligation further reduce rebleeding in cirrhotic patients, the rebleeding rate and mortality has a marked reduction. However, hepatocellular carcinoma (HCC) is a distinct group characteristic of very poor prognosis in patients with portal hypertension when compared to those of liver cirrhosis only. Therefore, the investigators design a study to randomize patients with HCC and acute variceal bleeding to endoscopic treatment alone and combination with endoscopic treatment and NSBB. This is the two years study.

Conditions

• Gastroesophageal Varices Hemorrhage
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	propranolol	Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

Timeline

• Start date: 2009-12-01
• Primary completion: 2020-07-31
• Completion: 2020-12-31
• First posted: 2011-10-14
• Last updated: 2019-09-04

Locations

1 site across 1 country: Taiwan