Back to resultsPrimary Prophylaxis of Gastric Varix Bleed
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Endoscopic cyanoacrylate injection
Beta-blocker (propranolol)
Sponsored by
About this trial
This is an interventional prevention trial for Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.
Exclusion Criteria:
- Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection.
- Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from GV
- Patients already on beta-blocker or nitrates
- Undetermined origin of bleeding from esophageal varix or gastric varix
- Hepatic encephalopathy grade III/IV
- Hepatorenal syndrome
- Hepatocellular carcinoma
- Presence of deep jaundice (serum bilirubin > 10 mg/dl)
- Uremia
- Cerebrovascular accident
- Cardiorespiratory failure
- Pregnancy and patients not giving informed consent for endoscopic procedures
Sites / Locations
- Shiv K Sarin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
Other
Arm Label
Endoscopic Cyanoacrylate injection
No Intervention
Beta-blocker (propranolol)
Arm Description
Endoscopic injection of cyanoacrylate in the gastric varix until obturation
No treatment offered for gastric varix
Beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
Outcomes
Primary Outcome Measures
Bleeding from gastric varix or death
Secondary Outcome Measures
Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications
Full Information
NCT ID
NCT00905996
First Posted
May 19, 2009
Last Updated
May 20, 2009
Sponsor
Govind Ballabh Pant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00905996
Brief Title
Primary Prophylaxis of Gastric Varix Bleed
Official Title
A Randomized Controlled Trial Comparing Cyanoacrylate Injection Versus Beta-Blockers Versus No Treatment for Primary Prophylaxis of Gastric Variceal Bleed
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Govind Ballabh Pant Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients who have never bled from gastric varix (GOV2 and IGV1), cyanoacrylate injection will be better than both beta-blocker therapy and no treatment in prevention of gastric variceal bleed. The investigators conducted a randomized controlled trial in patients with gastric varix (GOV2 and IGV1) who never bled before, to study the efficacy of treatment with cyanoacrylate injection versus beta-blocker versus no treatment in prevention of first bleed from gastric varices.
Detailed Description
Patients are followed up every 3 months or at the time of end point or complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic Cyanoacrylate injection
Arm Type
Active Comparator
Arm Description
Endoscopic injection of cyanoacrylate in the gastric varix until obturation
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No treatment offered for gastric varix
Arm Title
Beta-blocker (propranolol)
Arm Type
Other
Arm Description
Beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic cyanoacrylate injection
Other Intervention Name(s)
Glue injection in gastric varix
Intervention Description
Endoscopic cyanoacrylate injection in gastric varix
Intervention Type
Drug
Intervention Name(s)
Beta-blocker (propranolol)
Primary Outcome Measure Information:
Title
Bleeding from gastric varix or death
Time Frame
Within 2 years
Secondary Outcome Measure Information:
Title
Increase or decrease in the size of gastric varices, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy (PGP), complications
Time Frame
Within 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with GOV2 with eradicated esophageal varix or IGV1, who had never bled from gastric varix were included.
Exclusion Criteria:
Only esophageal varix, GOV1 with GOV2, acute bleed or past history of bleed from gastric varix, contraindications to beta-blocker therapy and cyanoacrylate injection.
Prior injection of cyanoacrylate or sclerotherapy or variceal ligation or transjugular intrahepatic portosystemic shunt or balloon-occluded retrograde transvenous obliteration or balloon-occluded endoscopic injection sclerotherapy of gastric varix for prevention of bleeding from GV
Patients already on beta-blocker or nitrates
Undetermined origin of bleeding from esophageal varix or gastric varix
Hepatic encephalopathy grade III/IV
Hepatorenal syndrome
Hepatocellular carcinoma
Presence of deep jaundice (serum bilirubin > 10 mg/dl)
Uremia
Cerebrovascular accident
Cardiorespiratory failure
Pregnancy and patients not giving informed consent for endoscopic procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv K Sarin, MD, DM
Organizational Affiliation
G B Pant Hospital, New Delhi, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiv K Sarin
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
21145834
Citation
Mishra SR, Sharma BC, Kumar A, Sarin SK. Primary prophylaxis of gastric variceal bleeding comparing cyanoacrylate injection and beta-blockers: a randomized controlled trial. J Hepatol. 2011 Jun;54(6):1161-7. doi: 10.1016/j.jhep.2010.09.031. Epub 2010 Nov 5.
Results Reference
derived
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Primary Prophylaxis of Gastric Varix Bleed
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