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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

About this trial

This is an interventional treatment trial for Gastroesophageal Varices

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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Scleroligation for Eradication of Gastroesophageal Varices.

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