NCT02945930

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 11, 2016

Last Update Submit

October 24, 2016

Conditions

Esophageal and Gastric Varices

Keywords

EnbucrilateEsophageal and Gastric VaricesEndoscopySafetyEfficacy

Outcome Measures

Primary Outcomes (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.

    Up to 2 months after the injection of histoacryl.

Secondary Outcomes (2)

  • Bleeding Rate

    14 days and 2 months after injection of histoacryl.

  • Rebleeding Rate

    14 days and 2 months after injection of histoacryl.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 22766643BACKGROUND

  • 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.

    PMID: 25045291BACKGROUND

  • 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.

    PMID: 24732750BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Shiyao Chen, Professor

    Shanghai Zhongshan Hospital

    STUDY CHAIR

Central Study Contacts

Shiyao Chen, Professor

CONTACT

86-13601767310chen.shiyao@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of Gastroenterology

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 26, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

November 1, 2018

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

CN(1)