Scleroligation for Eradication of Gastroesophageal Varices.

December 22, 2017 updated by: Sherief Abd-Elsalam

Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sclerotherapy group
thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%.
Procedure: Sclerotherapy
Injection of varices
Active Comparator: Endoscopic band ligation group
thirty patients treated by endoscopic banding using the Euro-Ligator system.
Procedure: Band ligation
endoscopic banding of varices
Experimental: Sclero-ligation (SL) group
thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation.
Procedure: Scleroligation
intra variceal endoscopic sclerotherapy combined with band ligation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of sessions to complete variceal obliteration
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Collaborators

Tanta University

Investigators

  • Study Chair: Abdelrahman kobtan, Consultant, liver diseases dept.-Tanta university hospital
  • Principal Investigator: Ferial El-kalla, Professor, Head of endoscopy unit - Tropical medicine department- Tanta
  • Principal Investigator: Mohamed Elhendawy, Consultant, liver diseases dept.- Tanta university hospital
  • Study Director: Loai Mansour, Consultant, liver diseases dept.-Tanta university hospital
  • Study Chair: Rehab Badawy, Consultant, liver diseases dept.-Tanta university hospital
  • Study Chair: Hanan Elbasat, Professor, liver diseases dept.-Tanta university hospital
  • Study Chair: Sherief Abd-Elsalam, Consultant, Liver diseases and gastroenterology dept.-Tanta university hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 1, 2016

First Submitted That Met QC Criteria

January 1, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Scleroligation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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