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

NCT ID: NCT01298284

Last Updated: 2011-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-12-31

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.

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.

Conditions

Liver Cirrhosis; Hepatoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EVL\GVS Alone

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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>

Group Type: ACTIVE_COMPARATOR

propranolol

Intervention Type: DRUG

Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

Interventions

propranolol

Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

Intervention Type: DRUG

Other Intervention Names

Inderal,Cardolol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Taipei Veterans General Hospital

Principal Investigators

Ming-Chih Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Veteran General Hospital-Taipei

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Chih Hou, MD

Role: CONTACT

mchou@vghtpe.gov.tw

886-2-28712111 ext. 3763

Han-Chieh Lin, MD

Role: CONTACT

hclin@vghtpe.gov.tw

886-2-28712111 ext. 3349

Facility Contacts

Ming-Chih Hou, MD

Role: primary

mchou@vghtpe.gov.tw

886-2-28712121 ext. 3763

Other Identifiers

IRB:98-09-09

Identifier Type: OTHER

Identifier Source: secondary_id

V99C1-026

Identifier Type: -

Identifier Source: org_study_id