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

October 4, 2010
June 14, 2011
October 2009
June 2010   (final data collection date for primary outcome measure)
Rebleeding [ Time Frame: 1 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01298284 on ClinicalTrials.gov Archive Site
complication surivial [ Time Frame: 1 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial of EVL\GVS Alone vs. EVL\GVS Combined Propranolol
Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With HCC:a Randomized Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Hepatoma
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
  • 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>

    Intervention: Drug: propranolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2011
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
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
Taiwan
 
NCT01298284
V99C1-026, IRB:98-09-09
Yes
MING CHIH HOU,M.D / Taipei Veterans General Hospital,Taiwan, Taipei Veterans General Hospital
Taipei Veterans General Hospital, Taiwan
Not Provided
Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP