A Randomized Trial of GVS Alone vs. Propranolol

NCT ID: NCT01298271

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2025-12-31

Brief Summary

Design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal bleeding.

Detailed Description

Up to date, the treatment of gastric variceal bleeding (GVB) is still sub-optimal in contrast to the treatment of esophageal variceal bleeding (EVB), which already had a big improvement of prognosis in recent two decades. Gastric varices (GV) rarely rupture. However should it occur, the outcome would be worse than rupture of esophageal varies (EV). Rupture of GV is characteristic of a higher rebleeding rate (90%), a requirement for a larger amount of blood transfusion and a higher mortality (40-50%). Therefore, primary prevention of GV rupture is critically important. The management of GV has been focused on treatment of acute GVB. Tissue adhesive (cyanoacrylate) may polymerize and occlude the vascular channels in seconds and obliterate for more than 70% cases of GV. The rebleeding rate after endoscopic cyanoacrylate injection(GVO) of acute GVB is around 30~40% and expertise is required to reduce the embolic complications and instrumental injuries.GVO may arrest more than 90% active GVB. The 2005 Baveno IV International Consensus and 2007 AASLD Guidelines endorsed that endoscopic cyanoacrylate injection is the first line treatment for acute GVB. However, its efficacy on prevention of first GV bleeding is not known. Non-selective beta-blocker (NSBB) is effective to prevent first and second bleeding from esophageal varices. The 2005 Baveno IV International Consensus and 2007 AASLD Guidelines also endorsed that NSBB is the first choice for the primary prevention of EVB. However, its effect on gastric variceal hemorrhage has never been clarified. Actually, GV usually has a large gastrorenal shunting and the portal pressure of GV is lower than that of EV. For ethical concerns, NSBB is usually be used for primary prevention of GVB, the preventive effect of NSBB had never been proved. Study on the primary prevention of GVB is scanty. This is an important issue prompted by current portal hypertension experts. The investigators have a lot of experience in the treatment of gastric variceal bleeding and published fruitful results in high ranking journals. Therefore, the investigators design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal bleeding.

Conditions

Bleeding Gastric Varices; Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyanoacrylate

Endoscopic Cyanoacrylate Injection treatment of primary prevention GVB

Group Type: NO_INTERVENTION

No interventions assigned to this group

Propranolol

Propranolol is used for primary prevention of GVB

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

1. patients with live cirrhosis and/or hepatoma

2. Aged 18 to 80, who had endoscopy-Proven EV(-)GV(+)or EV<GV

Exclusion Criteria

1. Patients had previous endoscopic, surgical treatment or Transjugular Intrahepatic Portosystemic Shunt

2. Had a terminal illness of any major organ system,such as heart failure, kindey 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

Responsibility Role: SPONSOR

Principal Investigators

Ming-Chih Hou, MD

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Locations

Veteran General Hospital-Taipei

Taipei, , 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

NSC99-2314-B-010-049-MY3

Identifier Type: -

Identifier Source: org_study_id