Primary Prevention of Gastric Variceal Bleeding : Endoscopic Treatment Versus Non-selective Beta-blocker

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01298271
First received: October 4, 2010
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Bleeding Gastric Varices
Liver Cirrhosis
Drug: propranolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of GVS Alone 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 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complication surivial [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Cyanoacrylate
Endoscopic Cyanoacrylate Injection treatment of primary prevention GVB
Active Comparator: Propranolol
Propranolol is used for primary prevention of GVB
Drug: propranolol
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
Other Name: Inderal, Cardolol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298271

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
Taiwan
Veteran General Hospital-Taipei Recruiting
Taipei, Taiwan, 11217
Contact: Ming-Chih Hou, MD    886-2-28712121 ext 3763    mchou@vghtpe.gov.tw   
Principal Investigator: Ming-Chih Hou, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
Investigators
Principal Investigator: Ming-Chih Hou, MD National Yang Ming University
  More Information

No publications provided

Responsible Party: Name/Official Title: MING CHIH HOU,M.D / National Taiwan University Hospital, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01298271     History of Changes
Other Study ID Numbers: NSC99-2314-13-010-049-MY3
Study First Received: October 4, 2010
Last Updated: June 14, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
gastric variceal bleeding
primaryprevention
cyanoacrylate injection
non-selective beta-blocker

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Varicose Veins
Hemorrhage
Liver Cirrhosis
Fibrosis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Propranolol
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
Vasodilator Agents

ClinicalTrials.gov processed this record on August 21, 2014