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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01451658
• Other study ID #: V99C1-026;V100C-024
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2009
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. clinical diagnosis of HCC

2. endoscopically proven acute variceal bleeding

3. younger than 18 years old or older than 80 years old

Exclusion Criteria:

-Had a terminal illness of any major organ system,such as heart failure, kidney failure,COPD

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Gastroesophageal Varices Hemorrhage
• Hemorrhage
• Hepatocellular Carcinoma

Intervention

Drug:
• propranolol
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

Locations

Country	Name	City	State
Taiwan	Veteran General Hospital-Taipei	Taipei	Ming-Chih Hou, MD

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	Rebleeding		2 year
Secondary	complication survival		2 year