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

Study Overview
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Brief Summary
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To observe the Safety and Efficacy of Compont Medical Glue in the Treatment of Esophagogastric Varices.

Detailed Description
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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.

Official Title
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A Prospective Multicenter, Open Study on the Safety and Efficacy of Compont Medical Glue in the Treatment of Esophagogastric Varices

Conditions
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Esophageal and Gastric Varices

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Occurrence Rate Of Different Adverse Event | Chest Pain/Epigastric Pain: Appears within 24 hours after injection of Compont Medical Glue and painkillers are used. Short-term Haemorrhage: Appears within 24 hours after injection of Compont Medical Glue. Glue Injection Related Bleeding: Appears within 2 months after injection of Compont Medical Glue confirmed by endoscopy. Fever: Patient has a fever over 38.0℃ within 3 days after injection of Compont Medical Glue. Ectopic Embolization: Appears within 3 days after injection of Compont Medical Glue and was confirmed by auxiliary examinations. Local Mucosal Necrosis: Local mucosal necrosis or ulcer appears around the injection poin within 2 months after injection of Compont Medical Glue. | Up to 2 months after the injection of histoacryl. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Rate | Data are analyzed separately as 14 days and 2 months for those patients who received endoscopic therapy for primary prevention of gastroesophageal varices bleeding. | 14 days and 2 months after injection of histoacryl. | 
| Rebleeding Rate | Data are analyzed separately as 14 days and 2 months for those patients who received endoscopic therapy for secondary prevention of gastroesophageal varices bleeding. | 14 days and 2 months after injection of histoacryl. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enbucrilate, Esophageal and Gastric Varices, Endoscopy, Safety, Efficacy