GVO-nadolol: Endoscopic Cyanoacrylate Obliteration vs. Nadolol Treatment in the Prevention of Gastric Variceal Rebleeding

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT00567216

Collaborator

National Science Council, Taiwan (Other)

120

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis and Hepatoma. Gastric Variceal Bleeding	Drug: Nadolol	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Randomized Tril of Endoscopic Cyanoacrylate Obliteration vs. Nadolol

Study Start Date :

Apr 1, 2007

Anticipated Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: G Endoscopic injection of cyanoacrylate alone
Active Comparator: C Combination of GVO and nadolol	Drug: Nadolol Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

Arm

Intervention/Treatment

No Intervention: G

Endoscopic injection of cyanoacrylate alone

Active Comparator: C

Combination of GVO and nadolol

Drug: Nadolol

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

Outcome Measures

Primary Outcome Measures

Rebleeding [3 yr]

Secondary Outcome Measures

Complication Survival [3 yr]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veteran General Hospital-Taipei	Taipei city	Taiwan	China	11217

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan
National Science Council, Taiwan

Investigators

Principal Investigator: Ming-Chih Hou, MD, Taipei Veterans General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00567216

Other Study ID Numbers:

nsc96-2314-B-075-037-MY3
IRB-96-04-01

First Posted:

Dec 4, 2007

Last Update Posted:

Jun 8, 2010

Last Verified:

Jun 1, 2010

Additional relevant MeSH terms:

Liver Cirrhosis

Nadolol

Study Results

No Results Posted as of Jun 8, 2010