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

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 4

Conditions: Gastroesophageal Varices Hemorrhage; Hepatocellular Carcinoma

Treatments: Drug: propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01451658

V99C1-026；V100C-024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

EVL or GVS treatment

No Intervention group

Description:

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)

Endoscopic treatment combined propranolol

Experimental group

Description:

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

Treatment:

Drug: propranolol