Esophageal and Gastric Varices
Conditions
Keywords
Enbucrilate, Esophageal and Gastric Varices, Endoscopy, Safety, Efficacy
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.
Interventions
None listed
Sponsors
Renmin Hospital of Wuhan University
The First Affiliated Hospital of Anhui Medical University
Lanzhou University Second Hospital
Shanghai Zhongshan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactShiyao Chen, Professor
Outcome results
None listed