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

NCT ID: NCT01451658

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

Gastroesophageal Varices Hemorrhage; Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EVL or GVS treatment

Endoscopic treatment alone is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.

endoscopic variceal ligation (EVL) or Gastric Variceal Sclerotherapy (GVS)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Endoscopic treatment combined propranolol

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

Group Type: EXPERIMENTAL

propranolol

Intervention Type: DRUG

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

Interventions

propranolol

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

Intervention Type: DRUG

Other Intervention Names

propranolol:Inderal,Cardolol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Veteran General Hospital-Taipei

Taipei, Ming-Chih Hou, MD, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Ming Chih Hou, MD

Role: primary

mchou@vghtpe.gov.tw

886-2-28712121 ext. 3763

Other Identifiers

V99C1-026；V100C-024

Identifier Type: -

Identifier Source: org_study_id