Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-26 @ 4:46 AM
Study NCT ID:
NCT02002559
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Narrow Band Imaging (NBI) Against Lugol for Squamous Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of superficial esophageal neoplasia', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Superficial Esophageal Neoplasia']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare Narrow Band Imaging (NBI) against Lugol chromoendoscopy for diagnosis of early esophageal cancers among high risk patients.', 'detailedDescription': 'The investigators recruited consecutive patients with head and neck cancers, history of squamous esophageal cancers treated by chemoradiotherapy or endoscopic resection. Endoscopic surveillance first started with NBI for detection and characterization of early esophageal cancers through observation of abnormal intrapapillary capillary loops (IPCL). Superficial esophageal neoplasia were diagnosed by IPCL Type IV, V1,V2 and Vn. Lugol chromoendoscopy would be performed subsequently and suspicious neoplasia were classified as understain or unstain lesions. The diagnostic accuracy, sensitivity and specificity of NBI were compared to Lugol chromoendoscopy with histology serving as a gold standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Patients with Head and Neck Cancer\n2. Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years\n3. Patients with esophageal cancer treated by endoscopic resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with Head and Neck Cancer\n2. Patients with esophageal cancer treated by chemoradiotherapy and in remission for 2 years\n3. Patients with esophageal cancer treated by endoscopic resection\n4. Age 18 to 80\n\nExclusion Criteria:\n\n1. Allergy to Lugol iodine\n2. Pregnancy\n3. Previous esophagectomy'}, 'identificationModule': {'nctId': 'NCT02002559', 'briefTitle': 'Narrow Band Imaging (NBI) Against Lugol for Squamous Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Endoscopic Surveillance Comparing Narrow Band Imaging (NBI) Against Lugol Chromoendoscopy for Detection of Synchronous Superficial Squamous Esophageal Neoplasia Among High Risk Patients', 'orgStudyIdInfo': {'id': '2006.077'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NBI Magnify Endoscopy', 'description': 'Detection of esphageal neoplasia through recognition of brownish discolored area via NBI and characterize the lesion using IPCL upon magnifying endoscopy'}, {'label': 'Lugol Chromoendoscopy', 'description': 'Detection of esophageal neoplasia through recognition of discolored area'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Philip WY Chiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Philip Wai Yan Chiu', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}