A Randomized Trial of GVS Alone vs. Propranolol (P-GVO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Bleeding Gastric Varices
• Intervention / Treatment: Drug: propranolol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ming-Chih Hou, MD; Phone Number: 3763 886-2-28712111; Email: mchou@vghtpe.gov.tw
• Study Contact Backup: Name: Han-Chieh Lin, MD; Phone Number: 3349 886-2-28712111; Email: hclin@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Veteran General Hospital-Taipei
    • Contact: Ming-Chih Hou, MD; Phone Number: 3763 886-2-28712121; Email: mchou@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Inderal, Cardolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rebleeding	3 year

Secondary Outcome Measures

Outcome Measure	Time Frame
complication surivial	3 year

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Ming-Chih Hou, MD, National Yang Ming University

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 17, 2011

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: gastric variceal bleeding; primaryprevention; cyanoacrylate injection; non-selective beta-blocker
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Fibrosis; Esophageal Diseases; Hypertension, Portal; Hemorrhage; Liver Cirrhosis; Esophageal and Gastric Varices; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: NSC99-2314-B-010-049-MY3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No