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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01451658
First received: October 10, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Varices Hemorrhage
Hepatocellular Carcinoma
Drug: propranolol
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Rebleeding [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: October 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: EVL or GVS treatment

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)

No Intervention: Endoscopic treatment alone versus combined propranolol
Endoscopic treatment alone versus combined propranolol is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.
Drug: propranolol
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
Other Name: propranolol:Inderal,Cardolol

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01451658

Locations
Taiwan
Veteran General Hospital-Taipei Recruiting
Taipei, Ming-Chih Hou, MD, Taiwan, 11217
Contact: Ming Chih Hou, MD    886-2-28712121 ext 3763    mchou@vghtpe.gov.tw   
Principal Investigator: Ming Chih Hou, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01451658     History of Changes
Other Study ID Numbers: V99C1-026;V100C-024
Study First Received: October 10, 2011
Last Updated: October 13, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Variceal bleeding
portal hypertension
hepatocellular carcinoma
endoscopic variceal ligation
non-selective beta-blocker
rebleeding

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Hemorrhage
Carcinoma
Esophageal and Gastric Varices
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 16, 2014