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

NCT ID: NCT02945930

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-11-30

Brief Summary

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

Detailed Description

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"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.

Conditions

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Esophageal and Gastric Varices

Keywords

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Enbucrilate Esophageal and Gastric Varices Endoscopy Safety Efficacy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shiyao Chen

Director of department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiyao Chen, Professor

Role: STUDY_CHAIR

Shanghai Zhongshan Hospital

Locations

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180 Fenglin Road

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shiyao Chen, Professor

Role: CONTACT

Phone: 86-13601767310

Email: [email protected]

Facility Contacts

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Ling Li, doctor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22766643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25045291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24732750 (View on PubMed)

Other Identifiers

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CSY-2016-ZZJ

Identifier Type: -

Identifier Source: org_study_id