Scleroligation for Eradication of Gastroesophageal Varices.

Gastroesophageal Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02646202
• Other study ID #: Scleroligation
• Status: Recruiting
• Phase: Phase 3
• First received: January 1, 2016
• Last updated: December 22, 2017
• Start date: January 2015
• Est. completion date: December 2021

Study information

• Verified date: December 2017
• Source: Tanta University
• Contact: Sherief M. Abd-Elsalam, Consultant
• Phone: 00201095159522
• Email: sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastroesophageal Varices
• Varicose Veins

Intervention

Procedure:
• Sclerotherapy
Injection of varices
• Band ligation
endoscopic banding of varices
• Scleroligation
intra variceal endoscopic sclerotherapy combined with band ligation.

Locations

Country	Name	City	State
Egypt	Tropical medicine dept.-Tanta university hospital	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sessions to complete variceal obliteration		1 year