Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Gastric Varices

What this study is about

This study compares two endoscopic ultrasound-guided treatments for gastric varices, which are enlarged veins in the stomach that can bleed. Both treatments use small coils placed into the varix. One group will receive coils with cyanoacrylate medical glue, and the other group will receive coils with absorbable gelatin sponge. The purpose of the study is to determine whether absorbable gelatin sponge with coils is not worse than cyanoacrylate glue with coils for closing off gastric varices, and to compare safety outcomes. Participants will be randomly assigned to one of the two treatment groups. Participants and outcome assessors will not know which treatment was used, but the doctor performing the procedure will know. After the procedure, participants will be followed for up to 12 months. Follow-up may include clinical assessments, questionnaires about health and quality of life, CT imaging shortly after the procedure, and repeat endoscopic ultrasound assessments to evaluate whether the gastric varix has been successfully treated.

Who can join (things the study team will check)

✅ You may be able to join if…

• Adults aged 18 years or older.
• Gastric varices deemed suitable for EUS-guided endoscopic treatment.
• History of suspected gastric variceal bleeding or active gastric variceal bleeding, with treatment intended for secondary prophylaxis.
• Ability to provide informed consent directly or through a substitute decision maker.
• Willingness and ability to undergo clinical follow-up, EUS assessment, and CT imaging.

🚫 You may not be able to join if…

• Inability or unwillingness to provide informed consent directly or through a substitute decision maker.
• No gastric varix present, or gastric varix too small or not amenable to combination therapy.
• Contraindication to therapeutic EUS or endoscopy.
• Contraindication to any study material used in the assigned treatment arm.
• Contraindication to contrast-enhanced CT, if not clinically manageable.
• Inability to complete planned follow-up.
• Pregnancy.
• Any clinical situation in which the treating endoscopist determines that randomization would be unsafe or inappropriate.

Where this trial is running

• St. Michael's Hospital - Unity Health Toronto, Toronto, Ontario, Canada

Who to contact

Kareem Khalaf, MD · +1-416-360-4000 · kareem.khalaf@unityhealth.to

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07699354.