Scleroligation for Eradication of Gastroesophageal Varices.
Primary Purpose
Gastroesophageal Varices
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Sclerotherapy
Band ligation
Scleroligation
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Varices
Eligibility Criteria
Inclusion Criteria:
- cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.
Exclusion Criteria:
- Patients were excluded if they had malignancy of any origin.
- Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.
- Other potential causes of GIT bleeding.
- Patients with previous endoscopic or surgical intervention for varices were also excluded.
Sites / Locations
- Tropical medicine dept.-Tanta university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Sclerotherapy group
Endoscopic band ligation group
Sclero-ligation (SL) group
Arm Description
thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%.
thirty patients treated by endoscopic banding using the Euro-Ligator system.
thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation.
Outcomes
Primary Outcome Measures
Number of sessions to complete variceal obliteration
Secondary Outcome Measures
Full Information
NCT ID
NCT02646202
First Posted
January 1, 2016
Last Updated
December 22, 2017
Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
1. Study Identification
Unique Protocol Identification Number
NCT02646202
Brief Title
Scleroligation for Eradication of Gastroesophageal Varices.
Official Title
Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gastric varices occur in 5-33% of patients with portal hypertension. Concomitant gastro esophageal varices are the most common type. Both endoscopic sclerotherapy and band ligation are very effective in controlling acute esophageal varices bleeding and preventing rebleeding.
Detailed Description
Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sclerotherapy group
Arm Type
Active Comparator
Arm Description
thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%.
Arm Title
Endoscopic band ligation group
Arm Type
Active Comparator
Arm Description
thirty patients treated by endoscopic banding using the Euro-Ligator system.
Arm Title
Sclero-ligation (SL) group
Arm Type
Experimental
Arm Description
thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation.
Intervention Type
Procedure
Intervention Name(s)
Sclerotherapy
Intervention Description
Injection of varices
Intervention Type
Procedure
Intervention Name(s)
Band ligation
Intervention Description
endoscopic banding of varices
Intervention Type
Procedure
Intervention Name(s)
Scleroligation
Intervention Description
intra variceal endoscopic sclerotherapy combined with band ligation.
Primary Outcome Measure Information:
Title
Number of sessions to complete variceal obliteration
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.
Exclusion Criteria:
Patients were excluded if they had malignancy of any origin.
Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.
Other potential causes of GIT bleeding.
Patients with previous endoscopic or surgical intervention for varices were also excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief M. Abd-Elsalam, Consultant
Phone
00201095159522
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferial El-kalla, Professor
Organizational Affiliation
Head of endoscopy unit - Tropical medicine department- Tanta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Elhendawy, Consultant
Organizational Affiliation
liver diseases dept.- Tanta university hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Loai Mansour, Consultant
Organizational Affiliation
liver diseases dept.-Tanta university hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdelrahman kobtan, Consultant
Organizational Affiliation
liver diseases dept.-Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rehab Badawy, Consultant
Organizational Affiliation
liver diseases dept.-Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hanan Elbasat, Professor
Organizational Affiliation
liver diseases dept.-Tanta university hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Consultant
Organizational Affiliation
Liver diseases and gastroenterology dept.-Tanta university hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tropical medicine dept.-Tanta university hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28082116
Citation
Mansour L, El-Kalla F, El-Bassat H, Abd-Elsalam S, El-Bedewy M, Kobtan A, Badawi R, Elhendawy M. Randomized controlled trial of scleroligation versus band ligation alone for eradication of gastroesophageal varices. Gastrointest Endosc. 2017 Aug;86(2):307-315. doi: 10.1016/j.gie.2016.12.026. Epub 2017 Jan 9.
Results Reference
derived
Learn more about this trial
Scleroligation for Eradication of Gastroesophageal Varices.
We'll reach out to this number within 24 hrs