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Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With Hepatocellular Carcinoma
Conditions
Gastroesophageal Varices Hemorrhage - Hepatocellular Carcinoma
Conditions: official terms
Carcinoma - Carcinoma, Hepatocellular - Esophageal and Gastric Varices - Hemorrhage
Conditions: Keywords
Variceal bleeding, portal hypertension, hepatocellular carcinoma, endoscopic variceal ligation, non-selective beta-blocker, rebleeding
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: propranolol
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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
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
Location
Veteran General Hospital-Taipei
Taipei, Ming-Chih Hou, MD, Taiwan
Status: Recruiting
Contact: Ming Chih Hou, MD - 886-2-28712121 - mchou@vghtpe.gov.tw
Start Date
December 2009
Completion Date
October 2012
Sponsors
Taipei Veterans General Hospital, Taiwan
Source
Taipei Veterans General Hospital, Taiwan
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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