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

Phase 4

• Conditions: Hepatocellular Carcinoma; Gastroesophageal Varices Hemorrhage
• Interventions: Drug: propranolol

• Registration Number: NCT01451658
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-04
• Primary Completion: 2020-07-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic treatment combined propranolol	propranolol	Endoscopic treatment alone versus combined propranolol is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.

Primary Outcome Measures

Name	Time	Method
Rebleeding	2 year

Secondary Outcome Measures

Name	Time	Method
complication survival	2 year

Trial Locations

Locations (1)

Veteran General Hospital-Taipei; 🇨🇳 Taipei, Ming-Chih Hou, MD, Taiwan