Back to resultsSecondary Prophylaxis Gastric Variceal 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 without esophageal varix or IGV1, who had bled from GV were included
Exclusion Criteria:
- Presence of esophageal varix
- GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
- Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding 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 or patients not giving informed consent for endoscopic procedures
Sites / Locations
- G B Pant Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1. Endoscopic Cyanoacrylate injection
2. Beta-blocker
Arm Description
Endoscopic Cyanoacrylate injection in the gastric varix
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
Rebleeding from GV or death
Secondary Outcome Measures
Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.
Full Information
NCT ID
NCT00888784
First Posted
April 27, 2009
Last Updated
April 27, 2009
Sponsor
Govind Ballabh Pant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00888784
Brief Title
Secondary Prophylaxis Gastric Variceal Bleed
Official Title
Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed
Study Type
Interventional
2. Study Status
Record Verification Date
April 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
The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.
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
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Endoscopic Cyanoacrylate injection
Arm Type
Active Comparator
Arm Description
Endoscopic Cyanoacrylate injection in the gastric varix
Arm Title
2. Beta-blocker
Arm Type
Placebo Comparator
Arm Description
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
Intervention Description
Endoscopic Cyanoacrylate injection in gastric varix
Intervention Type
Drug
Intervention Name(s)
beta-blocker (propranolol)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rebleeding from GV or death
Time Frame
Overall Study
Secondary Outcome Measure Information:
Title
Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications.
Time Frame
Overall Study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included
Exclusion Criteria:
Presence of esophageal varix
GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding 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 or 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
Director, G B Pant Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
20551457
Citation
Mishra SR, Chander Sharma B, Kumar A, Sarin SK. Endoscopic cyanoacrylate injection versus beta-blocker for secondary prophylaxis of gastric variceal bleed: a randomised controlled trial. Gut. 2010 Jun;59(6):729-35. doi: 10.1136/gut.2009.192039.
Results Reference
derived
Learn more about this trial
Secondary Prophylaxis Gastric Variceal Bleed
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