A Randomized Trial of GVS Alone vs. Propranolol

Liver Cirrhosis Clinical Trial

— P-GVO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01298271
• Other study ID #: NSC99-2314-B-010-049-MY3
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2010
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Ming-Chih Hou, MD
• Phone: 886-2-28712111
• Email: mchou[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Gastric Varices
• Esophageal and Gastric Varices
• Hemorrhage
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
Taiwan	Veteran General Hospital-Taipei	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rebleeding		3 year
Secondary	complication surivial		3 year