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Esophageal and Gastric VaricesNCT02945930

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

An observational study of Esophageal and Gastric Varices, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To observe the Safety and Efficacy of Compont Medical Glue in the Treatment of Esophagogastric Varices. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal and Gastric Varices
How many people
2,200 participants
Where
1 siteChina
Study dates
Sep 2016to Nov 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Shiyao Chen, Professor contact

86-13601767310

chen.shiyao@zs-hospital.sh.cn

China1 site, 1 recruiting

  • 180 Fenglin Road

    Shanghai, Shanghai Municipality, 200032

    Ling Li, doctor, 86-13601634690, sjezll@126.com

    Shiyao Chen, Professor

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Keywords
Enbucrilate, Esophageal and Gastric Varices, Endoscopy, Safety, Efficacy
Medical subject headings
Esophageal and Gastric Varices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 months after the injection of histoacryl.

Secondary outcomes (2)

  1. 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.

    Measured: 14 days and 2 months after injection of histoacryl.

  2. 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.

    Measured: 14 days and 2 months after injection of histoacryl.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionSep 2018 (estimated)
  4. Study completionNov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02945930
Sponsor's protocol ID
CSY-2016-ZZJ
Status last verified
Oct 2016
First submitted
11 Oct 2016
Last updated
26 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22766643

  • 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.

    PubMed 25045291

  • 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.

    PubMed 24732750

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal and Gastric Varices, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shiyao Chen, Professor (86-13601767310, chen.shiyao@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Occurrence Rate Of Different Adverse Event (time frame: Up to 2 months after the injection of histoacryl.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02945930, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.

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