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A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01298284
First received: October 4, 2010
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

New strategy to improve the outcomes in patients with HCC and acute variceal bleeding. NSBB added to endoscopic ligation may further reduce rebleeding in cirrhotic patients.


Condition Intervention Phase
Liver Cirrhosis
Hepatoma
Drug: propranolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With HCC:a Randomized Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rebleeding [ Time Frame: 1 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication surivial [ Time Frame: 1 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: December 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: EVL\GVS Alone
Endoscopic ligation treatment in the 2nd prevention of gastroesophageal variceal bleeding in patients with HCC
Active Comparator: EVL\GVS Combined Propranolol

Propranolol and endoscopic ligation treatment is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.

<EVL\GVS Combined Propranolol>

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: Inderal,Cardolol

Detailed Description:

Gastroesophageal vaiceal bleeding is a major complication of portal hypertension. Gastroesophageal variceal bleeding is characteristic of high rebleeding rate and mortality. Thanks to the recent advance of treatment including immediate vasoactive agents (such as somatostatin and vasopressin analogue for acute bleeding), non-selective beta-blocker (NSBB) for prevention of bleeding, prophylactic antibiotics, endoscopic variceal ligation, endoscopic cyanoacrylate injection , combination treatment and general improvement of care for patients with acute variceal bleeding, the rebleeding rate and mortality has a marked reduction. However, hepatocellular carcinoma (HCC) is a distinct group characteristic of very poor prognosis in patients in portal hypertensive patients when compared to those of liver cirrhosis only. Therefore it needs to specially clarify their treatment strategy, particularly in Taiwan, a highly prevalent area of HCC.

In patients of HCC presenting acute variceal bleeding, the rebleeding is around 50% doubled that of patients with cirrhosis only and bleeding mortality also more than 50%. The trend is not changed even after introduction of immediate use of vasoactive agents and endoscopic ligation. The poor outcome is because that HCC patients usually have arterioporal shunting or portal vein thrombosis and higher portal pressure. Moreover, their liver function deteriorated faster. Both high portal pressure and poor liver function are major determinant of hemostatic outcomes. Therefore, it is important to find a new strategy to improve the outcomes in patients with HCC and acute variceal bleeding.NSBB added to endoscopic ligation may further reduce rebleeding in cirrhotic patients. However, whether the hypotensive effect of NSBB is adequate to prevent rebleeding in patients with HCC who usually has higher portal pressure in not known. In addition, concomitant rapid deterioration of liver function might also dampen NSBB effects. Furthermore, due to faster deterioration of general condition, the tolerance of NSBB in these patients might be remarkable and lead to a higher withdrawal rate. Therefore, it is very important to clarify whether there is additive therapeutic effect of NSBB to endoscopic treatment in the 2nd prevention of gastroesophageal variceal bleeding in patients with HCC.

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:

  • Clinical diagnosis of HCC, endoscopically proven gastroesophageal variceal bleeding
  • Aged 18 to 80

Exclusion Criteria:

  • Had a terminal illness of any major organ system,such as heart failure, kidney failure, COPD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298284

Contacts
Contact: Ming-Chih Hou, MD 886-2-28712111 ext 3763 mchou@vghtpe.gov.tw
Contact: Han-Chieh Lin, MD 886-2-28712111 ext 3349 hclin@vghtpe.gov.tw

Locations
Taiwan
Veteran General Hospital-Taipei Recruiting
Taipei city, Taiwan
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
Investigators
Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: MING CHIH HOU,M.D / Taipei Veterans General Hospital,Taiwan, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01298284     History of Changes
Other Study ID Numbers: V99C1-026, IRB:98-09-09
Study First Received: October 4, 2010
Last Updated: June 14, 2011
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Liver Cirrhosis
Digestive System Diseases
Liver Diseases
Propranolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014