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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT00567216
First received: December 2, 2007
Last updated: June 6, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Liver Cirrhosis and Hepatoma.
Gastric Variceal Bleeding
Drug: Nadolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Tril of Endoscopic Cyanoacrylate Obliteration vs. Nadolol

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Rebleeding [ Time Frame: 3 yr ]

Secondary Outcome Measures:
  • Complication Survival [ Time Frame: 3 yr ]

Estimated Enrollment: 120
Study Start Date: April 2007
Estimated Study Completion Date: July 2010
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567216

Contacts
Contact: Ming-Chih Hou, MD 886-2-28712111 ext 3763 mchou@vghtpe.gov.tw
Contact: Han-Chieh Lin, MD 886-2-28712111 ext 3349 hclin@vghtpe.gov.tw

Locations
China, Taiwan
Veteran General Hospital-Taipei Recruiting
Taipei city, Taiwan, China, 11217
Contact: Ming-Chih Hou, MD    886-2-28712111 ext 3763    mchou@vghtpe.gov.tw   
Principal Investigator: Ming-Chih Hou, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Science Council, Taiwan
Investigators
Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00567216     History of Changes
Other Study ID Numbers: nsc96-2314-B-075-037-MY3, IRB-96-04-01
Study First Received: December 2, 2007
Last Updated: June 6, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hemorrhage
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Pathologic Processes
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Nadolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014