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

2026년 7월 9일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

64

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M5B 1W8
        • St. Michael's Hospital - Unity Health Toronto
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Sunil Gupta, MD, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
절차: 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.
다른 이름들:
  • Glue + Lipiodol + Coil; Cyanoacrylate Glue; Glubran2
실험적: 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.
절차: 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.
다른 이름들:
  • Gelfoam + Coil; Absorbable Gelatin Sponge; Gelfoam Slurry

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Complete Obliteration of the Target Gastric Varix on EUS
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Immediate Technical Success
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Unity Health Toronto

협력자

University of Toronto

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 11월 1일

연구 완료 (추정된)

2029년 8월 1일

연구 등록 날짜

최초 제출

2026년 7월 5일

QC 기준을 충족하는 최초 제출

2026년 7월 9일

처음 게시됨 (실제)

2026년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 9일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CoAGS-GV-UHT

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다