NCT03388125

Brief Summary

Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection

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
113

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_3

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

January 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1.6 years

First QC Date

December 23, 2017

Last Update Submit

April 20, 2018

Conditions

Bleeding Esophageal Varices

Outcome Measures

Primary Outcomes (1)

  • Number of patients with controlled bleeding

    The Number of patients with controlled bleeding

    6 months

Study Arms (2)

Injection Sclerotherapy

ACTIVE COMPARATOR

5% ethano lamine oleate

Drug: Injection Sclerotherapy

N-butyl-2-cyanoacrylate

ACTIVE COMPARATOR

N-butyl-2-cyanoacrylate injection group

Drug: N-butyl-2-cyanoacrylate

Interventions

Injection SclerotherapyDRUG

5% ethanolamine oleate group

Also known as: 5% ethanolamine oleate
Injection Sclerotherapy
N-butyl-2-cyanoacrylateDRUG

N-butyl-2-cyanoacrylate injection group

N-butyl-2-cyanoacrylate

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • cirrhotic patients presented with actively bleeding

You may not qualify if:

  • other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

Location

Related Publications (1)

  • Elsebaey MA, Tawfik MA, Ezzat S, Selim A, Elashry H, Abd-Elsalam S. Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial. BMC Gastroenterol. 2019 Feb 4;19(1):23. doi: 10.1186/s12876-019-0940-1.

    PMID: 30717684DERIVED

MeSH Terms

Interventions

ethanolamine oleateEnbucrilate

Intervention Hierarchy (Ancestors)

CyanoacrylatesAcrylatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrilesPolymersMacromolecular SubstancesBiomedical and Dental MaterialsTissue AdhesivesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mohamed Alsebaey, MD

    Gastroenterology

    PRINCIPAL INVESTIGATOR

  • Mohamed Abdelraouf, MD

    Gastroenterology

    STUDY DIRECTOR

  • Sherief Abd-Elsalam, MD

    Hepatology and Gastroenterology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

December 23, 2017

First Posted

January 2, 2018

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2022

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

EG(1)