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

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 4

Conditions: Liver Cirrhosis; Hepatoma

Treatments: Drug: propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01298284

IRB:98-09-09 (Other Identifier)

V99C1-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

EVL\GVS Alone

No Intervention group

Description:

Endoscopic ligation treatment in the 2nd prevention of gastroesophageal variceal bleeding in patients with HCC

EVL\GVS Combined Propranolol

Active Comparator group

Description:

Propranolol and endoscopic ligation treatment is used for 2nd prevention of gastroesophageal variceal bleeding in patients with HCC. \<EVL\\GVS Combined Propranolol\>

Treatment:

Drug: propranolol