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Phase 4
18 Years
80 Years
Open (Enrolling)
Both
Gastroesophageal Varices Hemorrhage, Hepatocellular Carcinoma

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Trial Information


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rebleeding

Outcome Time Frame:

2 year

Safety Issue:

No

Authority:

Taiwan: Department of Health

Study ID:

V99C1-026;V100C-024

NCT ID:

NCT01451658

Start Date:

December 2009

Completion Date:

October 2012

Related Keywords:

  • Gastroesophageal Varices Hemorrhage
  • Hepatocellular Carcinoma
  • Variceal bleeding
  • portal hypertension
  • hepatocellular carcinoma
  • endoscopic variceal ligation
  • non-selective beta-blocker
  • rebleeding
  • Carcinoma
  • Hemorrhage
  • Varicose Veins
  • Carcinoma, Hepatocellular
  • Esophageal and Gastric Varices

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