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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567216
Recruitment Status : Unknown
Verified June 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : December 4, 2007
Last Update Posted : June 8, 2010
National Science Council, Taiwan
Information provided by:
Taipei Veterans General Hospital, Taiwan

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2007
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Nadolol

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

Primary Outcome Measures :
  1. Rebleeding [ Time Frame: 3 yr ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567216

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Contact: Ming-Chih Hou, MD 886-2-28712111 ext 3763
Contact: Han-Chieh Lin, MD 886-2-28712111 ext 3349

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China, Taiwan
Veteran General Hospital-Taipei Recruiting
Taipei city, Taiwan, China, 11217
Contact: Ming-Chih Hou, MD    886-2-28712111 ext 3763   
Principal Investigator: Ming-Chih Hou, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Science Council, Taiwan
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Principal Investigator: Ming-Chih Hou, MD Taipei Veterans General Hospital, Taiwan

Layout table for additonal information Identifier: NCT00567216     History of Changes
Other Study ID Numbers: nsc96-2314-B-075-037-MY3
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: June 8, 2010
Last Verified: June 2010
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents