Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Gastric Varices

Condition(s) studied

Investigational drug(s) / intervention(s)

EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol: Endoscopic ultrasound-guided treatment of a gastric varix using coil deployment followed by injection of cyanoacrylate glue mixed with Lipiodol under direct visualization. The injection is flushed with sterile water. Repeat coil and/or glue injection may be performed at the discretion of the treating endoscopist. Doppler assessment is performed to assess eradication of flow in the treated gastric varix.

EUS-Guided Coil Embolization With Absorbable Gelatin Sponge: Endoscopic ultrasound-guided treatment of a gastric varix using coil deployment followed by injection of absorbable gelatin sponge slurry under direct visualization. The slurry is flushed with sterile water. Repeat coil and/or absorbable gelatin sponge injection may be performed at the discretion of the treating endoscopist. Doppler assessment is performed to assess eradication of flow in the treated gastric varix.

Study summary

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

Primary outcome measure(s)

• Complete Obliteration of the Target Gastric Varix on EUS — 3 months post-intervention
  Proportion of participants with complete obliteration of the target gastric varix, defined as cessation or absence of Doppler flow within the target varix on follow-up endoscopic ultrasound.

Trial sites (1)

More Unity Health Toronto trials in Canada