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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01451658
First Posted: October 14, 2011
Last Update Posted: October 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

Secondary Outcome Measures:
  • complication survival [ Time Frame: 2 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01451658     History of Changes
Other Study ID Numbers: V99C1-026;V100C-024
First Submitted: October 10, 2011
First Posted: October 14, 2011
Last Update Posted: October 14, 2011
Last Verified: October 2011

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
Carcinoma, Hepatocellular
Hemorrhage
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents