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

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ClinicalTrials.gov Identifier: NCT01451658
Recruitment Status : Unknown
Verified October 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : October 14, 2011
Last Update Posted : October 14, 2011
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief 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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Varices Hemorrhage Hepatocellular Carcinoma Drug: propranolol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2009
Actual Primary Completion Date : December 2009
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Rebleeding [ Time Frame: 2 year ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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


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
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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

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01451658     History of Changes
Other Study ID Numbers: V99C1-026;V100C-024
First Posted: October 14, 2011    Key Record Dates
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:
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Propranolol
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
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