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A study to assess the Comparison between Endoscopic Ultrasound-Guided Coil and n-butyl cyanoacrylate glue versus radiological intervention in preventing rebleeding in patients with gastric varices

Secondary prophylaxis of gastric variceal bleed: Endoscopic Ultrasound-Guided Coil and n-butyl cyanoacrylate glue versus radiological intervention: A Randomized Control Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046363
Enrollment
118
Registered
2022-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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: EUS guided coil embolization and n-butyl cyanoacrylate glue: Under the EUS guidance, gastric varices will be localized and its afferent pathway will be identified in Doppler study. Afte

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cirrhosis with acute variceal bleeding 2. GOV2 and IGV1 3. Age between 18-65 years 4. Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Variceal bleeding secondary to causes other than cirrhosis 2. Variceal bleeding from EV 3. Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathic disorder (hemophilia) apart from cirrhosis. 4. History of intake of platelets inhibitors (e.g., aspirin, clopidogrel) and drugs affecting coagulation cascade (e.g., vitamin K antagonists) within past 7 days 5. Pregnant women 6. History of underlying hypercoagulable/ hypocoagulable states e.g. paroxysmal nocturnal hemoglobinuria (PNH), and polycythemia vera. 7. Patients with refractory shock 8. Sepsis/ACLF 9. Contraindication to endoscopy 10. Not willing to provide consent.

Design outcomes

Primary

MeasureTime frame
1.To compare the rebleed rate between the EUS-guided coil embolization and glue injection with endoscopic cyanoacrylate glue injection and BRTO at 1 yearTimepoint: 1 year

Secondary

MeasureTime frame
1. All-cause mortality at 1 year 2. Grade of esophageal varices at 1, 3, 6, and 12 months 3. Complications and adverse events at 1, 3, 6, and 12 months Timepoint: 1. 1 Year 2. 1,2,3,6, and 12 months 3. 1,2,3,6, and 12 months

Countries

India

Contacts

Public ContactDr Deepak Gunjan

All India Institute of Medical Sciences

deepakgunjan31@gmail.com

Outcome results

None listed

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