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Scleroligation for Eradication of Gastroesophageal Varices.

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ClinicalTrials.gov Identifier: NCT02646202
Recruitment Status : Recruiting
First Posted : January 5, 2016
Last Update Posted : December 27, 2017
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Varices Procedure: Sclerotherapy Procedure: Band ligation Procedure: Scleroligation Phase 3

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.
Study Start Date : January 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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.




Primary Outcome Measures :
  1. Number of sessions to complete variceal obliteration [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02646202


Contacts
Contact: Sherief M. Abd-Elsalam, Consultant 00201095159522 sherif_tropical@yahoo.com

Locations
Egypt
Tropical medicine dept.-Tanta university hospital Recruiting
Tanta, Egypt
Contact: Sherief Abd-Elsalam       Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Tanta University
Investigators
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: Abdelrahman kobtan, 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University
ClinicalTrials.gov Identifier: NCT02646202     History of Changes
Other Study ID Numbers: Scleroligation
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Varicose Veins
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases