Gastric Varices BleedingCoAGS-GVNCT07699354
Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Gastric Varices
A study testing EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol and EUS-Guided Coil Embolization With Absorbable Gelatin Sponge in people with Gastric Varices Bleeding and Gastric Varices, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Varices Bleeding, Gastric Varices, Portal Hypertension
- What is being tested?
- EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol and EUS-Guided Coil Embolization With Absorbable Gelatin Sponge
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Michael's Hospital - Unity Health Toronto
Toronto, Ontario, M5B 1W8
Kareem Khalaf, MD, +1-416-360-4000 ext. 77537, kareem.khalaf@unityhealth.to
Katina Zheng, MD, +1-416-360-4000 ext. 77537, katina.zheng2@unityhealth.to
About this study
Official title: Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Endoscopic Treatment of Gastric Varices (CoAGS-GV): A Randomized, Patient- and Assessor-Blinded, Non-Inferiority 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.
Read the detailed description
Gastric varices are enlarged veins in the stomach that occur in patients with portal hypertension and can cause serious bleeding. Endoscopic ultrasound-guided therapy allows direct visualization of the target varix, placement of embolization coils, delivery of an embolic material, and Doppler assessment of blood flow after treatment.
Cyanoacrylate glue combined with coils is an established treatment approach for gastric varices. However, glue injection can be technically challenging and may be associated with complications such as embolization or equipment-related issues. Absorbable gelatin sponge, delivered as a slurry with coils, is an alternative approach that is used in clinical care and may avoid some of the practical limitations of glue. Comparative randomized data between these approaches are limited.
This is a randomized, patient- and assessor-blinded, non-inferiority trial comparing endoscopic ultrasound-guided coil embolization with cyanoacrylate glue versus endoscopic ultrasound-guided coil embolization with absorbable gelatin sponge for the treatment of gastric varices. Eligible participants will be randomized in a 1:1 ratio after confirmation of eligibility and informed consent. Randomization will occur intra-procedurally before treatment.
Participants assigned to the cyanoacrylate group will undergo endoscopic ultrasound-guided coil deployment followed by injection of cyanoacrylate glue mixed with Lipiodol. Participants assigned to the absorbable gelatin sponge group will undergo endoscopic ultrasound-guided coil deployment followed by injection of absorbable gelatin sponge slurry. In both groups, Doppler assessment will be used to evaluate blood flow in the target varix after treatment. Repeat coil and/or embolic material injection may be performed at the discretion of the treating endoscopist.
Participants will be monitored after the procedure for complications, including bleeding and embolization. Follow-up includes CT imaging approximately 48 hours after the procedure, clinical and questionnaire-based follow-up at 1, 3, 6, and 12 months, and repeat endoscopic assessment with endoscopic ultrasound at approximately 3 months and 12 months. The primary endpoint is complete obliteration of the target gastric varix, assessed by absence of Doppler flow on follow-up endoscopic ultrasound at 3 months. Secondary and tertiary outcomes include immediate technical success, clinical success, rebleeding, adverse events, hospital admission, ICU admission, transfusion requirements, reintervention, length of stay, procedural technical difficulty, costs, and health-related quality of life.
- Being tested
- EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol, EUS-Guided Coil Embolization With Absorbable Gelatin Sponge
- Keywords
- Endoscopic ultrasound, EUS-guided therapy, Portal hypertension, Cyanoacrylate glue, Absorbable gelatin sponge, Gelfoam, Coil embolization, Variceal obliteration, Secondary prophylaxis
- Medical subject headings
- Esophageal and Gastric Varices, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-Guided Coil Embolization With Cyanoacrylate Glue and LipiodolProcedure or surgery
Also called Glue + Lipiodol + Coil; Cyanoacrylate Glue; Glubran2
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 SpongeProcedure or surgery
Also called Gelfoam + Coil; Absorbable Gelatin Sponge; Gelfoam Slurry
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 group | Role | What they receive |
|---|---|---|
| Cyanoacrylate Glue + Lipiodol + Coil | Active comparator | 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. Receives: Procedure: EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol |
| Absorbable Gelatin Sponge + Coil | Experimental | 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. Receives: Procedure: EUS-Guided Coil Embolization With Absorbable Gelatin Sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-intervention
Secondary outcomes (5)
Immediate Technical Success
Successful EUS-guided deployment of coil and assigned embolic material into the gastric varix with cessation of Doppler flow at the end of the procedure.
Measured: During index procedure
Short-Term Clinical Success
Cessation of bleeding if present at baseline and/or absence of recurrent gastric variceal bleeding after the intervention.
Measured: Up to 3 months post-intervention
Procedure-Related Adverse Events
Rate and severity of procedure-related adverse events, categorized according to the ASGE Lexicon for endoscopic adverse events.
Measured: From index procedure through 12 months
Long-Term Technical Success
Complete obliteration of the treated gastric varix on repeat EUS, defined as absence of Doppler flow in the treated target varix.
Measured: 12 months post-intervention
Long-Term Clinical Success
Absence of recurrent gastric variceal bleeding and assessment of clinical durability after the intervention.
Measured: Up to 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastric Varices BleedingStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel treatment arms: EUS-guided coil with cyanoacrylate glue and Lipiodol, or EUS-guided coil with absorbable gelatin sponge. Randomization will occur intra-procedurally after eligibility is confirmed.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Sunil Gupta, Unity Health Toronto
- Investigators
- Sunil Gupta, MD, PhD, Principal investigator, Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699354
- Sponsor's protocol ID
- CoAGS-GV-UHT
- Acronym
- CoAGS-GV
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 17141231McCarty 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.
PubMed 31417066Bazarbashi 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.
PubMed 32010757Bazarbashi 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.
PubMed 32677809Florencio 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.
PubMed 39389435Bhat 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.
PubMed 26452992Kaplan 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.
PubMed 37870298
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Endoscopic Treatment of Gastric Varices (CoAGS-GV): A Randomized, Patient- and Assessor-Blinded, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07699354
- Acronym / sponsor ID
- CoAGS-GV / CoAGS-GV-UHT
- Keywords
- Endoscopic ultrasound, EUS-guided therapy, Portal hypertension, Cyanoacrylate glue, Absorbable gelatin sponge, Gelfoam, Coil embolization, Variceal obliteration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gastric varices are enlarged veins in the stomach that occur in patients with portal hypertension and can cause serious bleeding. Endoscopic ultrasound-guided therapy allows direct visualization of the target varix, placement of embolization coils, delivery of an embolic material, and Doppler assessment of blood flow after treatment.
Cyanoacrylate glue combined with coils is an established treatment approach for gastric varices. However, glue injection can be technically challenging and may be associated with complications such as embolization or equipment-related issues. Absorbable gelatin sponge, delivered as a slurry with coils, is an alternative approach that is used in clinical care and may avoid some of the practical limitations of glue. Comparative randomized data between these approaches are limited.
This is a randomized, patient- and assessor-blinded, non-inferiority trial comparing endoscopic ultrasound-guided coil embolization with cyanoacrylate glue versus endoscopic ultrasound-guided coil embolization with absorbable gelatin sponge for the treatment of gastric varices. Eligible participants will be randomized in a 1:1 ratio after confirmation of eligibility and informed consent. Randomization will occur intra-procedurally before treatment.
Participants assigned to the cyanoacrylate group will undergo endoscopic ultrasound-guided coil deployment followed by injection of cyanoacrylate glue mixed with Lipiodol. Participants assigned to the absorbable gelatin sponge group will undergo endoscopic ultrasound-guided coil deployment followed by injection of absorbable gelatin sponge slurry. In both groups, Doppler assessment will be used to evaluate blood flow in the target varix after treatment. Repeat coil and/or embolic material injection may be performed at the discretion of the treating endoscopist.
Participants will be monitored after the procedure for complications, including bleeding and embolization. Follow-up includes CT imaging approximately 48 hours after the procedure, clinical and questionnaire-based follow-up at 1, 3, 6, and 12 months, and repeat endoscopic assessment with endoscopic ultrasound at approximately 3 months and 12 months. The primary endpoint is complete obliteration of the target gastric varix, assessed by absence of Doppler flow on follow-up endoscopic ultrasound at 3 months. Secondary and tertiary outcomes include immediate technical success, clinical success, rebleeding, adverse events, hospital admission, ICU admission, transfusion requirements, reintervention, length of stay, procedural technical difficulty, costs, and health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel treatment arms: EUS-guided coil with cyanoacrylate glue and Lipiodol, or EUS-guided coil with absorbable gelatin sponge. Randomization will occur intra-procedurally after eligibility is confirmed.
| Arm | Type | Receives |
|---|---|---|
| Cyanoacrylate Glue + Lipiodol + Coil | Active comparator | Procedure: EUS-Guided Coil Embolization With Cyanoacrylate Glue and LipiodolParticipants 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 | Experimental | Procedure: EUS-Guided Coil Embolization With Absorbable Gelatin SpongeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-Guided Coil Embolization With Cyanoacrylate Glue and LipiodolAlso: Glue + Lipiodol + Coil; Cyanoacrylate Glue; Glubran2Endoscopic 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. | Procedure or surgery | Cyanoacrylate Glue + Lipiodol + Coil |
| EUS-Guided Coil Embolization With Absorbable Gelatin SpongeAlso: Gelfoam + Coil; Absorbable Gelatin Sponge; Gelfoam SlurryEndoscopic 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. | Procedure or surgery | Absorbable Gelatin Sponge + Coil |
Primary outcome
Complete Obliteration of the Target Gastric Varix on EUS
Time frame: 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.
5 secondary outcomes
Immediate Technical Success
Time frame: During index procedure
Short-Term Clinical Success
Time frame: Up to 3 months post-intervention
Procedure-Related Adverse Events
Time frame: From index procedure through 12 months
Long-Term Technical Success
Time frame: 12 months post-intervention
Long-Term Clinical Success
Time frame: Up to 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 17141231Saracco 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.
- Background: PubMed 31417066McCarty 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.
- Background: PubMed 32010757Bazarbashi 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.
- Background: PubMed 32677809Bazarbashi 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.
- Background: PubMed 39389435Florencio 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.
- Background: PubMed 26452992Bhat 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.
- Background: PubMed 37870298Kaplan 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sunil Gupta, MD, PhD principal investigator
Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-Guided Coil Embolization With Cyanoacrylate Glue and Lipiodol and EUS-Guided Coil Embolization With Absorbable Gelatin Sponge in people with Gastric Varices Bleeding and Gastric Varices, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kareem Khalaf, MD (+1-416-360-4000 ext. 77537, kareem.khalaf@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Obliteration of the Target Gastric Varix on EUS (time frame: 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07699354, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.