To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt

Study Overview
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Brief Summary
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Study population: All the consecutive patients of cirrhosis who are diagnosed to have large gastric varices without prior history of bleeding from GV, who came to OPD or endoscopy in Hepatology department of ILBS will be evaluated for inclusion. Study design: Prospective interventional study. The study will be conducted in the Department of Hepatology ILBS. Study period: 1.0 years Sample size: 60 This is a pilot RCT, and we decided to enroll 30 patients in each arm.

Official Title
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To Compare the Safety and Efficacy of Balloon Occluded/Plug Assisted Retrograde Transvenous Obliteration With Endoscopic Variceal Obturation for Primary Prophylaxis of Gastric Varices With Large Spontaneous Shunt: A Randomized Controlled Trial

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.
* Procedure: Endoscopic Variceal Obturation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years Cirrhotic patients, with GV (GOV2 or IGV1) with eradicated or small low risk esophageal varices with gastrorenal shunt of >10 mm size amenable for BRTO/PARTO. Exclusion Criteria: Non-cirrhotic portal hypertension, History of bleeding from GV Hepatic encephalopathy grade III/IV, Acute kidney injury Patients on beta blocker therapy for > 6 months prior to enrollment in study Hepatocellular carcinoma Portal venous thrombosis Presence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18 Advanced cardiac or pulmonary diseases Pregnancy Patients not giving informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balloon Occluded/plug assisted Retrograde Transvenous Obliteration.<br>Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only. | Procedure: Balloon occluded/plug assisted retrograde transvenous obliteration.<br>* Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only.<br>|
| Active Comparator: Endoscopic Variceal Obturation<br>endoscopic variceal glue therapy will be done till obturation every 3 weekly. | Procedure: Endoscopic Variceal Obturation<br>* Endoscopic Variceal Glue Therapy will be done till obturation every 3 weekly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patient having bleeding from GV at 12 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving complete or partial obturation of GV |  | 6 months | 
| Proportion of patients having change in grade of EV and bleeding from EV |  | 6 months | 
| Proportion of patients having appearance or worsening of PHG |  | 6 months | 
| Change in HVPG in those patients who bleed after BRTO/PRTO |  | 6 months | 
| Change in HVPG in those patients who bleed after EVO |  | 6 months | 
| Change in liver (in KPa) and splenic stiffness (in KPa) after BRTO/PRTO using transient elastography |  | 6 months | 
| Change in liver (in KPa) and splenic stiffness (in KPa) after using transient elastography |  | 6 months | 
| Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathy |  | 6 months | 
| Proportion of patient developing post procedure liver failure |  | 6 months | 
| Proportion of patient developing post acute kidney injury or sepsis |  | 6 months | 
| Duration of hospital stay poof procedure |  | 12 months |