Cyanoacrylate Glue vs Absorbable Gelatin Sponge for Gastric Varices
(CoAGS-GV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Sunil Gupta, MD, PhD
Principal Investigator
Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada
Are You a Good Fit for This Trial?
This trial is for adults with enlarged veins in the stomach (gastric varices) due to liver disease, such as cirrhosis or portal hypertension. Participants should be able to undergo an endoscopic procedure and follow-up visits.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- EUS-Guided Coil Embolization With Absorbable Gelatin Sponge
- EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol
Trial Overview
The study compares two treatments for gastric varices: one uses coils plus medical glue, and the other uses coils plus a gelatin sponge. Both are placed using ultrasound guidance during an endoscopy. Patients are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm will undergo endoscopic ultrasound-guided treatment of the target gastric varix using coil deployment followed by injection of absorbable gelatin sponge slurry. Repeat coil and/or absorbable gelatin sponge injection may be performed at the discretion of the treating endoscopist. Doppler assessment will be performed to assess eradication of flow in the treated gastric varix.
Participants randomized to this arm will undergo endoscopic ultrasound-guided treatment of the target gastric varix using coil deployment followed by injection of cyanoacrylate glue mixed with Lipiodol. Repeat coil and/or glue injection may be performed at the discretion of the treating endoscopist. Doppler assessment will be performed to assess eradication of flow in the treated gastric varix.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor
University of Toronto
Collaborator
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