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Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With HCC:a Randomized Trial

Phase 4
18 Years
80 Years
Open (Enrolling)
Liver Cirrhosis, Hepatoma

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Trial Information

Endoscopic Treatment Alone Versus Combined Propranolol and Endoscopic Treatment of Acute Variceal Hemorrhage in Patients With HCC:a Randomized Trial

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

1 years

Safety Issue:


Principal Investigator

Ming-Chih Hou, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taipei Veterans General Hospital,Taiwan


Taiwan: Department of Health

Study ID:




Start Date:

October 2009

Completion Date:

December 2011

Related Keywords:

  • Liver Cirrhosis
  • Hepatoma
  • Variceal bleeding
  • portal hypertension
  • hepatocelluar carcinoma
  • endoscopic variceal ligation
  • non-selective beta-blocker
  • rebleeding
  • Liver Cirrhosis
  • Fibrosis
  • Liver Neoplasms
  • Carcinoma, Hepatocellular