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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01451658

Enrollment

100

Registered

2011-10-14

Start date

2009-12-31

Completion date

2020-12-31

Last updated

2019-09-04

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

Conditions

Gastroesophageal Varices Hemorrhage, Hepatocellular Carcinoma

Keywords

Variceal bleeding, portal hypertension, hepatocellular carcinoma, endoscopic variceal ligation, non-selective beta-blocker, rebleeding

Brief 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.

Interventions

DRUGpropranolol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rebleeding	2 year

Secondary

Measure	Time frame
complication survival	2 year

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026