A clinical study to compare the effect of radiologic versus endoscopic or drug therapy for the prevention of the first episode of bleeding from gastric varices in patients with liver cirrhosis

Comparison of retrograde transvenous obliteration, endoscopic ultrasound-guided coil and glue embolization and beta blockers for primary prophylaxis of high-risk fundal varices in patients with liver cirrhosis: a Multi Centre open-label randomized controlled trial. - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/074042

Enrollment

135

Registered

2024-09-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: endoscopic ultrasound-guided coil embolization: Patients will undergo EUS-CCI within one week of randomization and will be followed up prospectively for 2 year. Number and size of coils

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with liver cirrhosis with high-risk fundal varices (GOV-2/IGV-1) which has never bled. 2. Age between 18-70 years 3. Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients with a prior history of bleeding from fundal varices 2. Porto sinusoidal vascular disease 3. Hepatocellular carcinoma ( beyond Milan criteria) or any other coexistent malignancy 4. Portal vein thrombosis or portal cavernoma 5. Contraindications to BRTO (provided in the table below) or prior BRTO 6. Active sepsis with or without septic shock 7. Underlying cardiopulmonary disease 8. Acute-on-Chronic liver failure as per EASL definition 9. Chronic Kidney Disease or Acute Kidney Injury with serum creatinine greater less 1.5 mg/dl 10. Pregnant women 11. Denied consent for participation

Design outcomes

Primary

Measure	Time frame
1.To assess the differences in the gastric varix hemorrhage rates at 1-year between the 3 armsTimepoint: 2 year	—

Secondary

Measure	Time frame
1. To assess the differences in all-cause and gastric varix bleeding-related mortality between the 3 arms at 12 and 24 months from randomization. 2. To evaluate the change in liver function (assessed by Model for end stage liver disease score) at 12 and 24 months from randomization between the 3 arms. 3. To assess the differences in complications- ascites/hepatic encephalopathy/esophageal variceal hemorrhage at 1, 3, 6,12 and 24 months between the 3 arms. 4. To assess the cost assessment between the three groups.Timepoint: 1. 12 and 24 months 2. 12 and 24 months 3. 24 months	—

Measure

Time frame

1. To assess the differences in all-cause and gastric varix bleeding-related mortality between the 3 arms at 12 and 24 months from randomization. 2. To evaluate the change in liver function (assessed by Model for end stage liver disease score) at 12 and 24 months from randomization between the 3 arms. 3. To assess the differences in complications- ascites/hepatic encephalopathy/esophageal variceal hemorrhage at 1, 3, 6,12 and 24 months between the 3 arms. 4. To assess the cost assessment between the three groups.Timepoint: 1. 12 and 24 months 2. 12 and 24 months 3. 24 months

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Countries

India

Contacts

Public ContactDr Sarthak Saxena

All India Institute of Medical Sciences

apeejaysarthak@gmail.com9953538070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026