SAFETY AND EFFICACY OF ENDOSCOPIC CONVENTIONAL CYANOACRYLATE GLUE VS EUS-GUIDED COIL PLUS CYANOACRYLATE TECHNIQUE IN THE TREATMENT OF GASTRIC VARICES: A RANDOMIZED CONTROLLED TRIAL (GLUE)
Glue; Dependence
About this trial
This is an interventional treatment trial for Glue; Dependence
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years old, patients diagnosed with
- gastric varices larger than 2.0 cm in total diameter of the vascular pseudotumor type GOV2 or IGV 1.
- Active bleeder
- Secondary prophylaxis - h/o previous bleed
- High risk GV (GOV 2/IGV 1) - Baveno VI-
- Primary prophylaxis
Excusion criteria:
- Previous HRS
- MOF
- Platelet <50,000/cumm
- INR>2
- Esophageal stricture
- Iodine allergy (for EV)
Sites / Locations
- Asian Institute of GastroenterologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Cyanoacrylate injection and EUS guided coil and glue injection
COIL and GLUE
The procedure would be performed under conscious sedation.The endoscope would be used to reach the site of Varices. In Conventional technique treatment with cyanoacrylate the injection was performed using a 23-G sclerotherapy needle catheter . One vial of N-butyl-2-cyanoacrylate (0.5 mL) was mixed with Lipiodol) in a 1:1 ratio, and injected intravesically as a 1 mL bolus. The injection was repeated until total hardening of the varix. In treatment with coil and cyanoacrylate once the gastric varix was identified, the total diameter of the vascular pseudotumor was measured and the puncture was made at the site of the widest varix. The puncture was performed using a 19 G needle . the size of the coil after release should not be greater than the caliber of the vessel. Following coil deployment, 2 mL of distilled water was injected, followed by one vial (0.5 mL) of N-butyl-2-cyanoacrylate mixed with Lipiodol in 1:1 ratio.
Cyanoacrylate injection, first published by Soehendra in 1986, remains the conventional treatment method. Since coils were first used to treat ectopic varices by Levy in 2008(6), this technique has been increasingly implemented into clinical practice. However, its higher cost has been a limiting factor in more widespread use. Depending on the ectasia of the varix the following coil was deployed: 8 mm x 20 cm, 10 mm x 20 cm, or 10 mm x 30 cm (Interlock-18 Fibered IDC Occlusion System,Cook).