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

• Conditions: Esophageal and Gastric Varices

• Registration Number: NCT02945930
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-09
• Status Verified: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-24
• Last Update Submitted: 2016-10-24
• Study First Posted: 2016-10-26
• Last Update Posted: 2016-10-26
• Primary Completion: 2018-09
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Occurrence Rate Of Different Adverse Event	Up to 2 months after the injection of histoacryl.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China