Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Gastric Varices
CoAGS-GV
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
July 13, 2026
July 1, 2026
1.3 years
July 5, 2026
July 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Obliteration of the Target Gastric Varix on EUS
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.
3 months post-intervention
Secondary Outcomes (5)
Immediate Technical Success
During index procedure
Short-Term Clinical Success
Up to 3 months post-intervention
Procedure-Related Adverse Events
From index procedure through 12 months
Long-Term Technical Success
12 months post-intervention
Long-Term Clinical Success
Up to 12 months post-intervention
Other Outcomes (9)
Transfusion Requirements
From index procedure through 12 months
Rebleeding
From index procedure through 12 months
Hospital Length of Stay
From index admission up to 30 days
- +6 more other outcomes
Study Arms (2)
Cyanoacrylate Glue + Lipiodol + Coil
ACTIVE COMPARATORParticipants 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.
Absorbable Gelatin Sponge + Coil
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify 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 qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- University of Torontocollaborator
Study Sites (1)
St. Michael's Hospital - Unity Health Toronto
Toronto, Ontario, M5B 1W8, Canada
Related Publications (7)
Saracco G, Giordanino C, Roberto N, Ezio D, Luca T, Caronna S, Carucci P, De Bernardi Venon W, Barletti C, Bruno M, De Angelis C, Musso A, Repici A, Suriani R, Rizzetto M. Fatal multiple systemic embolisms after injection of cyanoacrylate in bleeding gastric varices of a patient who was noncirrhotic but with idiopathic portal hypertension. Gastrointest Endosc. 2007 Feb;65(2):345-7. doi: 10.1016/j.gie.2006.07.009. Epub 2006 Dec 1. No abstract available.
PMID: 17141231BACKGROUNDMcCarty TR, Bazarbashi AN, Hathorn KE, Thompson CC, Ryou M. Combination therapy versus monotherapy for EUS-guided management of gastric varices: A systematic review and meta-analysis. Endosc Ultrasound. 2020 Jan-Feb;9(1):6-15. doi: 10.4103/eus.eus_37_19.
PMID: 31417066BACKGROUNDBazarbashi AN, Wang TJ, Thompson CC, Ryou M. Endoscopic ultrasound-guided treatment of gastric varices with coil embolization and absorbable hemostatic gelatin sponge: a novel alternative to cyanoacrylate. Endosc Int Open. 2020 Feb;8(2):E221-E227. doi: 10.1055/a-1027-6708. Epub 2020 Jan 28.
PMID: 32010757BACKGROUNDBazarbashi AN, Wang TJ, Jirapinyo P, Thompson CC, Ryou M. Endoscopic Ultrasound-Guided Coil Embolization With Absorbable Gelatin Sponge Appears Superior to Traditional Cyanoacrylate Injection for the Treatment of Gastric Varices. Clin Transl Gastroenterol. 2020 May;11(5):e00175. doi: 10.14309/ctg.0000000000000175.
PMID: 32677809BACKGROUNDFlorencio de Mesquita C, Antunes VLJ, Milioli NJ, Fernandes MV, Correa TL, Martins OC, Chavan R, Baraldo S. EUS-guided coiling plus glue injection compared with endoscopic glue injection alone in endoscopic treatment for gastric varices: a systematic review and meta-analysis. Gastrointest Endosc. 2025 Feb;101(2):331-340.e8. doi: 10.1016/j.gie.2024.10.005. Epub 2024 Oct 9.
PMID: 39389435BACKGROUNDBhat YM, Weilert F, Fredrick RT, Kane SD, Shah JN, Hamerski CM, Binmoeller KF. EUS-guided treatment of gastric fundal varices with combined injection of coils and cyanoacrylate glue: a large U.S. experience over 6 years (with video). Gastrointest Endosc. 2016 Jun;83(6):1164-72. doi: 10.1016/j.gie.2015.09.040. Epub 2015 Oct 9.
PMID: 26452992BACKGROUNDKaplan DE, Ripoll C, Thiele M, Fortune BE, Simonetto DA, Garcia-Tsao G, Bosch J. AASLD Practice Guidance on risk stratification and management of portal hypertension and varices in cirrhosis. Hepatology. 2024 May 1;79(5):1180-1211. doi: 10.1097/HEP.0000000000000647. Epub 2023 Oct 23. No abstract available.
PMID: 37870298BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunil Gupta, MD, PhD
Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and outcome assessors will be masked to treatment allocation. The endoscopist performing the procedure will not be masked because of the nature of the interventions. Procedural details will not be disclosed to participants or independent outcome assessors, and blinded assessors will not have access to the procedural note or treatment allocation at the time of outcome assessment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 5, 2026
First Posted
July 13, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
August 1, 2029
Last Updated
July 13, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning after publication of the main study results and available for up to 5 years after publication.
- Access Criteria
- Requests will be considered from qualified researchers with a methodologically sound proposal for purposes consistent with the informed consent and applicable ethics and privacy requirements. Access may require approval from the study investigators and/or institution and completion of a data sharing agreement.
De-identified individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request, subject to review and approval by the study investigators, Unity Health Toronto institutional requirements, applicable privacy legislation, and any required data sharing agreement. No information that directly identifies participants will be shared.