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

9 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

64

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital - Unity Health Toronto
        • Contact:
        • Contact:
        • Chercheur principal:
          • Sunil Gupta, MD, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Procédure: 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.
Autres noms:
  • Glue + Lipiodol + Coil; Cyanoacrylate Glue; Glubran2
Expérimental: 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.
Procédure: 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.
Autres noms:
  • Gelfoam + Coil; Absorbable Gelatin Sponge; Gelfoam Slurry

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Complete Obliteration of the Target Gastric Varix on EUS
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Immediate Technical Success
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Transfusion Requirements
Délai: From index procedure through 12 months
Number of blood product transfusions required after the intervention.
From index procedure through 12 months
Rebleeding
Délai: 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
Délai: 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
Délai: From index procedure through 12 months
Occurrence of ICU admission after the intervention.
From index procedure through 12 months
Hospital Readmission
Délai: From index procedure through 12 months
Occurrence of hospital readmission after the index intervention.
From index procedure through 12 months
Reintervention for Gastric Varices
Délai: 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
Délai: During index procedure
Operator-assessed technical difficulty, including procedure time, device use, and challenges encountered during the intervention.
During index procedure
Intervention Cost
Délai: During index procedure
Cost of the intervention, including use of coils and assigned embolic material.
During index procedure
Health-Related Quality of Life
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Unity Health Toronto

Collaborateurs

University of Toronto

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 novembre 2027

Achèvement de l'étude (Estimé)

1 août 2029

Dates d'inscription aux études

Première soumission

5 juillet 2026

Première soumission répondant aux critères de contrôle qualité

9 juillet 2026

Première publication (Réel)

13 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CoAGS-GV-UHT

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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