Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-01 @ 6:42 PM
Study NCT ID:
NCT02646202
Status:
UNKNOWN
Last Update Posted:
2017-12-27
First Post:
2016-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scleroligation for Eradication of Gastroesophageal Varices.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015911', 'term': 'Sclerotherapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2016-01-01', 'studyFirstSubmitQcDate': '2016-01-01', 'lastUpdatePostDateStruct': {'date': '2017-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of sessions to complete variceal obliteration', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gastroesophageal Varices']}, 'referencesModule': {'references': [{'pmid': '28082116', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Evaluation of a new scleroligation technique for management of bleeding gastro-esophageal varices regarding efficacy, complications, variceal recurrence, and survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cirrhotic patients presenting with an acute or recent episode of gastro-esophageal variceal bleeding.\n\nExclusion Criteria:\n\n* Patients were excluded if they had malignancy of any origin.\n* Any terminal illness, such as heart failure, uremia, or chronic pulmonary diseases.\n* Other potential causes of GIT bleeding.\n* Patients with previous endoscopic or surgical intervention for varices were also excluded.'}, 'identificationModule': {'nctId': 'NCT02646202', 'briefTitle': 'Scleroligation for Eradication of Gastroesophageal Varices.', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Scleroligation is a Safe and Effective New Technique for Eradication of Gastroesophageal Varices.', 'orgStudyIdInfo': {'id': 'Scleroligation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sclerotherapy group', 'description': 'thirty patients treated by sclerotherapy for OV using ethanolamine oleate 5%.', 'interventionNames': ['Procedure: Sclerotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endoscopic band ligation group', 'description': 'thirty patients treated by endoscopic banding using the Euro-Ligator system.', 'interventionNames': ['Procedure: Band ligation']}, {'type': 'EXPERIMENTAL', 'label': 'Sclero-ligation (SL) group', 'description': 'thirty patients treated by intra variceal endoscopic sclerotherapy combined with band ligation.', 'interventionNames': ['Procedure: Scleroligation']}], 'interventions': [{'name': 'Sclerotherapy', 'type': 'PROCEDURE', 'description': 'Injection of varices', 'armGroupLabels': ['Sclerotherapy group']}, {'name': 'Band ligation', 'type': 'PROCEDURE', 'description': 'endoscopic banding of varices', 'armGroupLabels': ['Endoscopic band ligation group']}, {'name': 'Scleroligation', 'type': 'PROCEDURE', 'description': 'intra variceal endoscopic sclerotherapy combined with band ligation.', 'armGroupLabels': ['Sclero-ligation (SL) group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-Elsalam', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com'}], 'facility': 'Tropical medicine dept.-Tanta university hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief M. Abd-Elsalam, Consultant', 'role': 'CONTACT', 'email': 'sherif_tropical@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Ferial El-kalla, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of endoscopy unit - Tropical medicine department- Tanta'}, {'name': 'Mohamed Elhendawy, Consultant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'liver diseases dept.- Tanta university hospital'}, {'name': 'Loai Mansour, Consultant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'liver diseases dept.-Tanta university hospital'}, {'name': 'Abdelrahman kobtan, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'liver diseases dept.-Tanta university hospital'}, {'name': 'Rehab Badawy, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'liver diseases dept.-Tanta university hospital'}, {'name': 'Hanan Elbasat, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'liver diseases dept.-Tanta university hospital'}, {'name': 'Sherief Abd-Elsalam, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'Liver diseases and gastroenterology dept.-Tanta university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant liver and GIT diseases- Tanta university hospital', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}