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Study the Safety and Efficacy of "Compont Medical Glue" in the Treatment of Esophagogastric Varices

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Fudan University

Status

Unknown

Conditions

Esophageal and Gastric Varices

Study type

Observational

Funder types

Other

Identifiers

NCT02945930
CSY-2016-ZZJ

Details and patient eligibility

About

To observe the Safety and Efficacy of Compont Medical Glue in the Treatment of Esophagogastric Varices.

Full description

"Compont Medical Glue" is a kind of histoacryl producted by Compont Company. It has been used to treat esophagogastric varices for several years. This study is a prospective multicenter,open study on the safety and efficacy of Compont Medical Glue in the treatment of esophagogastric varices. Weather the patient receiving injection of Compont Medical Glue is according to the degree of esophageal-gastric varices and is decided by the experienced endoscopic physicians. No additional intervention will be given to the patients, no matter whether patients are participated in the study.

Enrollment

2,200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Esophagogastric varices caused by portal hypertension with or without history of bleeding and no matter whether emergency bleeding.
  • Patients may need to receive injection of histoacryl.
  • Have signed informed consent.

Exclusion criteria

  • Allergic to formaldehyde or cyanoacrylate.
  • Women who are pregnant or breast-feeding.
  • With contraindications of endoscopic exam.
  • Computed tomography(CT)/Computed tomography angiography(CTA) shows that patient with severe portosystemic shunt.
  • Large amount of blood accumulated in the stomach severely affects the endoscopic vision clarity.
  • Other reasons that researcher think the patient is unsuitable for participating in the study.

Trial contacts and locations

1

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Central trial contact

Shiyao Chen, Professor

Data sourced from clinicaltrials.gov

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