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

October 24, 2016 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

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

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • 180 Fenglin Road
        • Principal Investigator:
          • Shiyao Chen, Professor
        • Sub-Investigator:
          • Jie Chen, doctor
        • Contact:
        • Sub-Investigator:
          • Ling Li, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with esophagogastric varices caused by portal hypertension who might need to receive endoscopy treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 months after the injection of histoacryl.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days and 2 months after injection of histoacryl.
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.
14 days and 2 months after injection of histoacryl.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

The First Affiliated Hospital of Anhui Medical University
Renmin Hospital of Wuhan University
Lanzhou Second People's Hospital

Investigators

  • Study Chair: Shiyao Chen, Professor, Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSY-2016-ZZJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal and Gastric Varices

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe