Scleroligation for Eradication of Gastroesophageal Varices.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02646202|
Recruitment Status : Recruiting
First Posted : January 5, 2016
Last Update Posted : December 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Varices||Procedure: Sclerotherapy Procedure: Band ligation Procedure: Scleroligation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Sclerotherapy group
thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%.
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.
intra variceal endoscopic sclerotherapy combined with band ligation.
- Number of sessions to complete variceal obliteration [ Time Frame: 1 year ]
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
|Contact: Sherief M. Abd-Elsalam, Consultantfirstname.lastname@example.org|
|Tropical medicine dept.-Tanta university hospital||Recruiting|
|Contact: Sherief Abd-Elsalam Sherif_tropical@yahoo.com|
|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|