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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary: "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.
Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome: The Occurrence Rate Of Different Adverse Event [ Time Frame: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bleeding Rate [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: October 11, 2016
Date Started: September 2016
Date Completion: November 2018
Last Updated: October 24, 2016
Last Verified: October 2016