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

Esophageal and Gastric Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02945930
• Other study ID #: CSY-2016-ZZJ
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 24, 2016
• Start date: September 2016
• Est. completion date: November 2018

Study information

• Verified date: October 2016
• Source: Shanghai Zhongshan Hospital
• Contact: Shiyao Chen, Professor
• Phone: 86-13601767310
• Email: chen.shiyao[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: November 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Varicose Veins

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Lanzhou Second People's Hospital, Renmin Hospital of Wuhan University, The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Jun CH, Kim KR, Yoon JH, Koh HR, Choi WS, Cho KM, Lim SU, Park CH, Joo YE, Kim HS, Choi SK, Rew JS. Clinical outcomes of gastric variceal obliteration using N-butyl-2-cyanoacrylate in patients with acute gastric variceal hemorrhage. Korean J Intern Med. 2014 Jul;29(4):437-44. doi: 10.3904/kjim.2014.29.4.437. — View Citation

Khawaja A, Sonawalla AA, Somani SF, Abid S. Management of bleeding gastric varices: a single session of histoacryl injection may be sufficient. Eur J Gastroenterol Hepatol. 2014 Jun;26(6):661-7. doi: 10.1097/MEG.0000000000000080. — View Citation

Monsanto P, Almeida N, Rosa A, Maçôas F, Lérias C, Portela F, Amaro P, Ferreira M, Gouveia H, Sofia C. Endoscopic treatment of bleeding gastric varices with histoacryl (N-butyl-2-cyanoacrylate): a South European single center experience. Indian J Gastroenterol. 2013 Jul;32(4):227-31. doi: 10.1007/s12664-012-0191-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No