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Efficacy of balloon occluded/plug assisted retrograde transvenous obliteration (procedure) in liver disease.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049078
Enrollment
60
Registered
2023-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: Balloon occluded/plug assisted retrograde transvenous obliteration.: Balloon occluded/plug assisted retrograde transvenous obliteration will be done one time only. Control Intervention

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years 2. 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

Exclusion criteria: 1. Non-cirrhotic portal hypertension, 2. History of bleeding from GV 3. Hepatic encephalopathy grade III/IV, 4. Acute kidney injury 5. Patients on beta blocker therapy for > 6 months prior to enrollment in study 6. Hepatocellular carcinoma 7. Portal venous thrombosis 8. Presence of jaundice (bilirubin >3 mg/dl), ascites, Child C, MELD > 18 9. Advanced cardiac or pulmonary diseases 10. Pregnancy 11. Patients not giving informed consent

Design outcomes

Primary

MeasureTime frame
Proportion of patient having bleeding from GV at 12 monthsTimepoint: 6 months—

Secondary

MeasureTime frame
Proportion of patients achieving complete or partial obturation of GVTimepoint: 6 months;Proportion of patients having change in grade of EV and bleeding from EVTimepoint: 6 months;Proportion of patients having appearance or worsening of PHGTimepoint: 6 months;Change in HVPG in those patients who bleed after BRTO/PRTOTimepoint: 6 months;Change in HVPG in those patients who bleed after EVOTimepoint: 6 months;Change in liver and splenic stiffness after BRTO/PRTOTimepoint: 6 months;Change in liver and splenic stiffness after EVOTimepoint: 6 months;Proportion of patients having new onset decompensation with ascites, jaundice or hepatic encephalopathyTimepoint: 6 months;Proportion of patient developing post procedure liver failureTimepoint: 6 months;Proportion of patient developing post acute kidney injury or sepsisTimepoint: 6 months;Duration of hospital stayTimepoint: 12 months—

Countries

India

Contacts

Public ContactDr Shiv Kumar Sarin

Institute of Liver and Biliary Sciences

shivsarin@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026