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

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Unknown status
CT.gov ID
NCT01298284
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
26
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Anticipated Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Inderal,Cardolol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rebleeding [1 years]

    Secondary Outcome Measures

    1. complication surivial [1 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Veteran General Hospital-Taipei Taipei city Taiwan

    Sponsors and Collaborators

    • Taipei Veterans General Hospital, Taiwan

    Investigators

    • Principal Investigator: Ming-Chih Hou, MD, Taipei Veterans General Hospital, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01298284
    Other Study ID Numbers:
    • V99C1-026
    • IRB:98-09-09
    First Posted:
    Feb 17, 2011
    Last Update Posted:
    Jun 15, 2011
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    Variceal bleeding
    portal hypertension
    hepatocelluar carcinoma
    endoscopic variceal ligation
    non-selective beta-blocker
    rebleeding
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Propranolol

    Study Results

    No Results Posted as of Jun 15, 2011