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Comparison of n-butyl cyanoacrylate glue alone versus n-butyl cyanoacrylate glue plus radiological intervention in preventing rebleeding in patients with gastric varices

N-butyl cyanoacrylate glue versus N-butyl cyanoacrylate glue plus radiologic intervention for secondary prophylaxis of gastric varices: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031396
Enrollment
90
Registered
2021-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K922- Gastrointestinal hemorrhage, unspecified

Interventions

Intervention1: Radiological intervention for secondary prophylaxis of gastric varices: Patients randomized to this arm will be assessed for presence of shunt vessel feeding the gastric varix. If prese

Sponsors

Dr Shalimar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with upper GI bleed originating from GOV-2/IGV-1, seen on endoscopy 2. Age between 18-65 years 3. Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Failure to control bleed or early rebleed 2. Non-cirrhotic causes of portal hypertension 3. Hepatocellular carcinoma 4. Portal vein thrombosis/Portal cavernoma 5. Contraindications to beta-blockers 6. Active sepsis with or without septic shock 7. Underlying cardiopulmonary disease 8. Prior glue/TIPSS/BRTO 9. Chronic Kidney Disease or Acute kidney injury with Creatinine >1.5 10. HE grade 1 and above/or past history of HE 11. Pregnant females 12. MELD >20 13. Acute on chronic liver failure as defined by EASL criteria 14. Death within 72 hours of admission 15. Biliary malignancy 16. Denied consent for participation

Design outcomes

Primary

MeasureTime frame
Comparison of GV rebleed rates between the 2 groups (Glue alone vs glue plus radiological intervention)Timepoint: 1 year—

Secondary

MeasureTime frame
All cause rebleeding ratesTimepoint: 12 months;Amount of glue and sessions of endoscopy for GV obliterationTimepoint: 1,3,6 and 12 months;Assessment of complication rates- ulcer formation/embolism/ascites/HETimepoint: 1, 3, 6 and 12 months.;Assessment of technical successTimepoint: At baseline;Change in liver function (MELD and CTP)Timepoint: 1, 3, 6 and 12 months;Number and duration of hospitalizationsTimepoint: 1,3,6 and 12 months;Overall and GV bleed related mortalityTimepoint: 1, 3, 6, and 12 months;Overall Cost of the proceduresTimepoint: At baseline;Rate of aggravation of esophageal varicesTimepoint: 1,3,6 and 12 months;Rate of GV obliterationTimepoint: 1,3,6 and 12 months—

Countries

India

Contacts

Public ContactDr Sagnik Biswas

All India Institute of Medical Sciences, New Delhi

drshalimar@yahoo.com9868397211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026