Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
Study NCT ID:
NCT04388150
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2020-05-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Narrow Band Spectrum Endoscopy for the Diagnosis of Gastric Antral Vascular Ectasia in Patients With Liver Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020252', 'term': 'Gastric Antral Vascular Ectasia'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016888', 'term': 'Angiodysplasia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Narrow Band Spectrum endoscopy for the diagnosis of Gastric antral vascular ectasia in cirrhotic patients', 'timeFrame': 'it is estimated to be 12 months', 'description': 'It is done by the new technology of VIST which is similar to Narrow Band Imaging in the diagnosis of Gastric antral vascular ectasia in cirrhotic patients that were misdiagnosed before as portal hypertension gastropathy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Narrow Band'], 'conditions': ['Gastric Antral Vascular Ectasia']}, 'descriptionModule': {'briefSummary': 'the study aims to evaluate the role of similar technology of Narrow Band Imaging VIST video intelligent staining technology in the diagnosis of Gastric Antral Vascular ectasia in cirrhotic patients', 'detailedDescription': 'VIST (Video intelligent staining technology) is used to the diagnosis of GAVE as the form of ectatic vessels in the antrum in instead of erosions in the antrum by White light endoscopy which can mislead the diagnosis to Portal hypertension gastropathy. Targeted biopsies are taken and examined histopathologically in order to see if matching with VIST view. In addition, CD61 is used to highlight the diagnosis for more confirmation. CD61 is an immunohistochemistry platelets marker.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes all cirrhotic patients undergoing Upper gastrointestinal endoscopy and they have antral erosions by endoscopy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mucosal vascular lesions at the gastric antrum suspicious of GAVE of a linear striped form or a diffuse punctate form upon conventional WLE\n\nExclusion Criteria:\n\n* Connective tissue disorders like systemic sclerosis.\n* Chronic kidney disease.\n* Recent use of proton pump inhibitors in the last 14 days.\n* History of gastric surgery or gastric cancer.\n* Pernicious anemia.\n* Recent history of non-steroidal anti-inflammatory drugs intake'}, 'identificationModule': {'nctId': 'NCT04388150', 'briefTitle': 'Efficacy of Narrow Band Spectrum Endoscopy for the Diagnosis of Gastric Antral Vascular Ectasia in Patients With Liver Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Efficacy of Narrow Band Spectrum Endoscopy Versus Histopathology for the Diagnosis of Gastric Antral Vascular Ectasia in Patients With Liver Cirrhosis', 'orgStudyIdInfo': {'id': '0201288'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Upper gastrointestinal endoscopy and biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Gastroscope with technology of VIST video intelligent staining technology for taking biopsies'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Internal Medicine, Hepatology Unit. Faculty of Medicine, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Randa Salah Eldin Abdelmoneim, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer, Internal Medicine Department', 'investigatorFullName': 'Randa Salah', 'investigatorAffiliation': 'Alexandria University'}}}}