ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02945930
Recruitment Status : Unknown
Verified October 2016 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : October 26, 2016
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
Renmin Hospital of Wuhan University
The First Affiliated Hospital of Anhui Medical University
Lanzhou Second People's Hospital
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

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

Condition or disease
Esophageal and Gastric 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.

Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multicenter, Open Study on the Safety and Efficacy of "Compont Medical Glue" in the Treatment of Esophagogastric Varices
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with esophagogastric varices caused by portal hypertension who might need to receive endoscopy treatment.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945930


Contacts
Contact: Shiyao Chen, Professor 86-13601767310 chen.shiyao@zs-hospital.sh.cn

Locations
China, Shanghai
180 Fenglin Road Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ling Li, doctor    86-13601634690    sjezll@126.com   
Principal Investigator: Shiyao Chen, Professor         
Sub-Investigator: Jie Chen, doctor         
Sub-Investigator: Ling Li, doctor         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Renmin Hospital of Wuhan University
The First Affiliated Hospital of Anhui Medical University
Lanzhou Second People's Hospital
Investigators
Study Chair: Shiyao Chen, Professor Shanghai Zhongshan Hospital

Publications:
Responsible Party: Shiyao Chen, Director of department of Gastroenterology, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02945930     History of Changes
Other Study ID Numbers: CSY-2016-ZZJ
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:
Enbucrilate
Esophageal and Gastric Varices
Endoscopy
Safety
Efficacy

Additional relevant MeSH terms:
Varicose Veins
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases