Endoscopic Cyanoacrylate Obliteration vs. Nadolol Treatment in the Prevention of Gastric Variceal Rebleeding

NCT ID: NCT00567216

Last Updated: 2010-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-07-31

Brief Summary

Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized combination of GVO and BB can further decrease the rebleeding rate.

Detailed Description

Gastric varies (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, a requirement for a larger amount of blood transfusion and a higher mortality. Up to date, the treatment of GV bleeding (GVB) is still sub-optimal in contrast to the treatment of EV bleeding. The management of GV has been focused on treatment of acute GVB. Various specific methods are used to control GVB and prevent rebleeding; however they were far from ideal. It is because GV are usually larger vessels formed in deeper submucosa and connect to the spontaneous gastrorenal shunt which creates a fast blood flow. Therefore, voluminous blood in the larger diameter GV leads to exsanguine bleeding when ruptured. A variety of endoscopic methods, which include injection of sclerosants, tissue adhesive (cyanoacrylate), thrombin and ligation with rubber bands, detachable nylon loop and steel snares, are applied to control acute GV bleeding with variable successful rates (50~100%) and rebleeding rates (20~90%). The successful rate of endoscopic cyanoacrylate injection to arrest active GVB is more consistent around 90~100% and rebleeding rate is around 30~40%. The recent International Consensus Meeting endorsed that endoscopic cyanoacrylate injection is the first line treatment for acute GVB. The embolic complications, either septic & aseptic, are not uncommon. Expertise is also required to reduce the embolic complications and instrumental injuries. Therefore, the efficacy of specific treatment for GVB is sub-optimal, consecutive innovation of new methods are required to improve the prognosis of GVB. Non-selective beta-blocker is effective to reduce rebleeding from esophageal varices. However, its effect on gastric variceal hemorrhage has never been proven.

This is an important issues prompted by current portal hypertension experts. We have much experience in the treatment of gastric variceal bleeding and published fruitful results in high ranking journal. Therefore, we design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the secondary prevention of acute gastric variceal bleeding.

Conditions

Liver Cirrhosis and Hepatoma.; Gastric Variceal Bleeding

Study Design

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

Study Groups

G

Endoscopic injection of cyanoacrylate alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

C

Combination of GVO and nadolol

Group Type: ACTIVE_COMPARATOR

Nadolol

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

Nadolol

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

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of liver cirrhosis and/or HCC, endoscopically proven gastric variceal bleeding

Exclusion Criteria

• younger than 18 y/o or older than 80 y/o, terminal illness, other major systemic disease or malignancy

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

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Ming-Chih Hou, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

Veteran General Hospital-Taipei

Taipei City, Taiwan, China

Site Status: RECRUITING

Countries

China

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

886-2-28712111 ext. 3763

Other Identifiers

IRB-96-04-01

Identifier Type: -

Identifier Source: secondary_id

nsc96-2314-B-075-037-MY3

Identifier Type: -

Identifier Source: org_study_id