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

Primary Purpose

Bleeding Gastric Varices, Liver Cirrhosis

Status
Recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
propranolol
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding Gastric Varices focused on measuring gastric variceal bleeding, primaryprevention, cyanoacrylate injection, non-selective beta-blocker

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veteran General Hospital-TaipeiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Cyanoacrylate

Propranolol

Arm Description

Endoscopic Cyanoacrylate Injection treatment of primary prevention GVB

Propranolol is used for primary prevention of GVB

Outcomes

Primary Outcome Measures

Rebleeding

Secondary Outcome Measures

complication surivial

Full Information

First Posted
October 4, 2010
Last Updated
August 29, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01298271
Brief Title
A Randomized Trial of GVS Alone vs. Propranolol
Acronym
P-GVO
Official Title
Primary Prevention of Gastric Variceal Bleeding : Endoscopic Treatment Versus Non-selective Beta-blocker
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Gastric Varices, Liver Cirrhosis
Keywords
gastric variceal bleeding, primaryprevention, cyanoacrylate injection, non-selective beta-blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyanoacrylate
Arm Type
No Intervention
Arm Description
Endoscopic Cyanoacrylate Injection treatment of primary prevention GVB
Arm Title
Propranolol
Arm Type
Active Comparator
Arm Description
Propranolol is used for primary prevention of GVB
Intervention Type
Drug
Intervention Name(s)
propranolol
Other Intervention Name(s)
Inderal, Cardolol
Intervention Description
Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
Primary Outcome Measure Information:
Title
Rebleeding
Time Frame
3 year
Secondary Outcome Measure Information:
Title
complication surivial
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with live cirrhosis and/or hepatoma Aged 18 to 80, who had endoscopy-Proven EV(-)GV(+)or EV<GV Exclusion Criteria: Patients had previous endoscopic, surgical treatment or Transjugular Intrahepatic Portosystemic Shunt Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Chih Hou, MD
Phone
886-2-28712111
Ext
3763
Email
mchou@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Han-Chieh Lin, MD
Phone
886-2-28712111
Ext
3349
Email
hclin@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Chih Hou, MD
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veteran General Hospital-Taipei
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Chih Hou, MD
Phone
886-2-28712121
Ext
3763
Email
mchou@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Ming-Chih Hou, MD

12. IPD Sharing Statement

Learn more about this trial

A Randomized Trial of GVS Alone vs. Propranolol

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