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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastroesophageal Varices Hemorrhage, Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: propranolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of HCC endoscopically proven acute variceal bleeding 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: EVL or GVS treatment<br>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) | |
| Experimental: Endoscopic treatment combined propranolol<br>Endoscopic treatment alone versus combined propranolol is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC. | Drug: propranolol<br>* Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period<br>* Other names: propranolol:Inderal,Cardolol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication survival |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, Variceal bleeding, portal hypertension, endoscopic variceal ligation, non-selective beta-blocker, rebleeding