Clinical trial NCT02945930: Study the Safety and Efficacy of "Compont Medical Glue" in the Treatment of Esophagogastric Varices
Official title: A Prospective Multicenter, Open Study on the Safety and Efficacy of "Compont Medical Glue" in the Treatment of Esophagogastric Varices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal and Gastric Varices
Keywords: Enbucrilate
Esophageal and Gastric Varices
Endoscopy
Safety
Efficacy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Renmin Hospital of Wuhan University
name: The First Affiliated Hospital of Anhui Medical University
name: Lanzhou University Second Hospital
First posted: 2016-10-26
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophagogastric varices caused by portal hypertension who might need to receive endoscopy treatment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Occurrence Rate Of Different Adverse Event
timeFrame: Up to 2 months after the injection of histoacryl.
Secondary outcomes:
measure: Bleeding Rate
timeFrame: 14 days and 2 months after injection of histoacryl.
measure: Rebleeding Rate
timeFrame: 14 days and 2 months after injection of histoacryl.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Shiyao Chen, Professor
role: STUDY_CHAIR
References:
citation: Monsanto P, Almeida N, Rosa A, Macoas F, Lerias 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. Epub 2012 Jul 6.
citation: 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. Epub 2014 Jun 27.
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.