Secondary Prophylaxis Gastric Variceal Bleed

Study Overview
=================
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.

Official Title
-----------------
Endoscopic Cyanoacrylate Injection Versus Beta-Blockers for Secondary Prophylaxis of Gastric Variceal Bleed

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Procedure: Endoscopic Cyanoacrylate injection
* Drug: beta-blocker (propranolol)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Endoscopic Cyanoacrylate injection<br>Endoscopic Cyanoacrylate injection in the gastric varix | Procedure: Endoscopic Cyanoacrylate injection<br>* Endoscopic Cyanoacrylate injection in gastric varix<br>* Other names: Glue injection;|
| Placebo Comparator: 2. Beta-blocker<br>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. | Drug: beta-blocker (propranolol)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding from GV or death |  | Overall Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase or decrease in the size of GV, appearance of new esophageal varices and appearance or worsening of portal hypertensive gastropathy and complications. |  | Overall Study |