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

Information source: Taipei Veterans General Hospital,Taiwan
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Varices Hemorrhage; Hepatocellular Carcinoma

Intervention: propranolol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Taipei Veterans General Hospital,Taiwan

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rebleeding

Secondary outcome: complication survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): 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

Locations and Contacts

Veteran General Hospital-Taipei, Taipei, Ming-Chih Hou, MD 11217, Taiwan; Recruiting
Ming Chih Hou, MD, Phone: 886-2-28712121, Ext: 3763, Email: mchou@vghtpe.gov.tw
Ming Chih Hou, MD, Principal Investigator
Additional Information

Starting date: December 2009
Last updated: October 13, 2011

Page last updated: February 07, 2013

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