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

9 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

64

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Canadá
    • Ontario
      • Toronto, Ontario, Canadá, M5B 1W8
        • St. Michael's Hospital - Unity Health Toronto
        • Contato:
        • Contato:
        • Investigador principal:
          • Sunil Gupta, MD, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Procedimento: 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.
Outros nomes:
  • Glue + Lipiodol + Coil; Cyanoacrylate Glue; Glubran2
Experimental: 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.
Procedimento: 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.
Outros nomes:
  • Gelfoam + Coil; Absorbable Gelatin Sponge; Gelfoam Slurry

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Complete Obliteration of the Target Gastric Varix on EUS
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Immediate Technical Success
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Unity Health Toronto

Colaboradores

University of Toronto

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de novembro de 2027

Conclusão do estudo (Estimado)

1 de agosto de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

5 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de julho de 2026

Primeira postagem (Real)

13 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CoAGS-GV-UHT

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento 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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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