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Cyanoacrylate Glue Versus Absorbable Gelatin Sponge for Gastric Varices (CoAGS-GV)

9. juli 2026 opdateret af: Sunil Gupta, Unity Health Toronto

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital - Unity Health Toronto
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Sunil Gupta, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Cyanoacrylate Glue + Lipiodol + Coil
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.
Procedure: 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.
Andre navne:
  • Glue + Lipiodol + Coil; Cyanoacrylate Glue; Glubran2
Eksperimentel: Absorbable Gelatin Sponge + Coil
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.
Procedure: 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.
Andre navne:
  • Gelfoam + Coil; Absorbable Gelatin Sponge; Gelfoam Slurry

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Obliteration of the Target Gastric Varix on EUS
Tidsramme: 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.
3 months post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immediate Technical Success
Tidsramme: During index procedure
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.
During index procedure
Short-Term Clinical Success
Tidsramme: Up to 3 months post-intervention
Cessation of bleeding if present at baseline and/or absence of recurrent gastric variceal bleeding after the intervention.
Up to 3 months post-intervention
Procedure-Related Adverse Events
Tidsramme: From index procedure through 12 months
Rate and severity of procedure-related adverse events, categorized according to the ASGE Lexicon for endoscopic adverse events.
From index procedure through 12 months
Long-Term Technical Success
Tidsramme: 12 months post-intervention
Complete obliteration of the treated gastric varix on repeat EUS, defined as absence of Doppler flow in the treated target varix.
12 months post-intervention
Long-Term Clinical Success
Tidsramme: Up to 12 months post-intervention
Absence of recurrent gastric variceal bleeding and assessment of clinical durability after the intervention.
Up to 12 months post-intervention

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Transfusion Requirements
Tidsramme: From index procedure through 12 months
Number of blood product transfusions required after the intervention.
From index procedure through 12 months
Rebleeding
Tidsramme: From index procedure through 12 months
Occurrence of recurrent gastric variceal bleeding after the index intervention.
From index procedure through 12 months
Hospital Length of Stay
Tidsramme: From index admission up to 30 days
Length of hospital stay associated with the index presentation and intervention.
From index admission up to 30 days
ICU Admission
Tidsramme: From index procedure through 12 months
Occurrence of ICU admission after the intervention.
From index procedure through 12 months
Hospital Readmission
Tidsramme: From index procedure through 12 months
Occurrence of hospital readmission after the index intervention.
From index procedure through 12 months
Reintervention for Gastric Varices
Tidsramme: From index procedure through 12 months
Need for additional endoscopic, interventional radiology, surgical, or other therapy for gastric varices after the index intervention.
From index procedure through 12 months
Procedural Technical Difficulty
Tidsramme: During index procedure
Operator-assessed technical difficulty, including procedure time, device use, and challenges encountered during the intervention.
During index procedure
Intervention Cost
Tidsramme: During index procedure
Cost of the intervention, including use of coils and assigned embolic material.
During index procedure
Health-Related Quality of Life
Tidsramme: 1, 3, 6, and 12 months post-intervention
Health-related quality of life assessed using the SF-36 questionnaire.
1, 3, 6, and 12 months post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Unity Health Toronto

Samarbejdspartnere

University of Toronto

Efterforskere

  • Ledende efterforsker: Sunil Gupta, MD, PhD, Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

5. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CoAGS-GV-UHT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning after publication of the main study results and available for up to 5 years after publication.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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