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

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: NCT03388125
Recruitment Status : Active, not recruiting
First Posted : January 2, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Brief Summary:
Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection

Condition or disease Intervention/treatment Phase
Bleeding Esophageal Varices Drug: Injection Sclerotherapy Drug: N-butyl-2-cyanoacrylate Phase 3

Detailed Description:
Endoscopic Injection Sclerotherapy versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : August 1, 2017
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Injection Sclerotherapy
5% ethano lamine oleate
Drug: Injection Sclerotherapy
5% ethanolamine oleate group
Other Name: 5% ethanolamine oleate

Active Comparator: N-butyl-2-cyanoacrylate
N-butyl-2-cyanoacrylate injection group
Drug: N-butyl-2-cyanoacrylate
N-butyl-2-cyanoacrylate injection group




Primary Outcome Measures :
  1. Number of patients with controlled bleeding [ Time Frame: 6 months ]
    The Number of patients with controlled bleeding



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cirrhotic patients presented with actively bleeding

Exclusion Criteria:

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

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): NCT03388125


Locations
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Egypt
Sherief Abd-Elsalam
Tanta, Egypt
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Mohamed Alsebaey, MD Gastroenterology
Study Director: Mohamed Abdelraouf, MD Gastroenterology
Study Director: Sherief Abd-Elsalam, MD Hepatology and Gastroenterology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sherief Abd-Elsalam, Investigator, Tanta University
ClinicalTrials.gov Identifier: NCT03388125    
Other Study ID Numbers: Active bleeding
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Ethanolamine oleate
Sclerosing Solutions
Pharmaceutical Solutions