Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Gastric Varices
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol
- EUS-Guided Coil Embolization With Absorbable Gelatin Sponge
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
Unity Health Toronto
Lead sponsor
University of Toronto
Collaborator
Source ClinicalTrials.gov