Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT03696992
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2018-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 884}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2018-09-27', 'studyFirstSubmitQcDate': '2018-10-03', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proximal adenoma detection rate', 'timeFrame': 'one day', 'description': 'proportion of patients with proximal adenoma detected on first examination'}], 'secondaryOutcomes': [{'measure': 'proximal polyp detection rate', 'timeFrame': 'one day', 'description': 'proportion of patients with proximal polyp detected on first examination'}, {'measure': 'proximal adenoma miss rate', 'timeFrame': 'one day', 'description': 'proportion of patients with proximal adenoma detected on second examination'}, {'measure': 'proximal polyp miss rate', 'timeFrame': 'one day', 'description': 'proportion of patients with proximal polyp detected on second examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy'], 'conditions': ['Colon Adenoma']}, 'referencesModule': {'references': [{'pmid': '37307902', 'type': 'DERIVED', 'citation': 'Leung WK, Tsui VWM, Mak LL, Cheung MK, Hui CK, Lam CP, Wong SY, Liu KS, Ko MK, To EW, Guo CG, Lui TK. Blue-light imaging or narrow-band imaging for proximal colonic lesions: a prospective randomized tandem colonoscopy study. Gastrointest Endosc. 2023 Nov;98(5):813-821.e3. doi: 10.1016/j.gie.2023.06.004. Epub 2023 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.', 'detailedDescription': "Study population:\n\nConsecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital are invited to participate in this prospective randomized study. Patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses will be excluded. In addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is \\<2.\n\nStudy design and randomization:\n\nThis is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of BLI (ELUXEO endoscopic system) vs NBI (290 video system) vs WLI which is conducted in the Endoscopy Center of the Queen Mary Hospital of Hong Kong. Eligible patients are randomly allocated to four groups in a 1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The three groups are: (1) NBI follow by WLI; (2) BLI follow up WLI; (3) WLI follow by WLI. Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). All procedures are performed with high-definition endoscopes. The patients are blinded to the group assignment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40 or above\n* scheduled for colonoscopy\n\nExclusion Criteria:\n\n* unable to provide informed consent\n* have undergone previous colorectal resection,\n* personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes.\n* Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses\n* poor bowel preparation'}, 'identificationModule': {'nctId': 'NCT03696992', 'acronym': 'BNW', 'briefTitle': 'BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'UW18-420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NBI', 'description': 'Tandem colonoscopy with NBI follow by WL', 'interventionNames': ['Procedure: Tandem colonoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BLI', 'description': 'Tandem colonoscopy with BLI follow by WLI', 'interventionNames': ['Procedure: Tandem colonoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'WLI', 'description': 'Tandem colonoscopy with WLI follow by WL', 'interventionNames': ['Procedure: Tandem colonoscopy']}], 'interventions': [{'name': 'Tandem colonoscopy', 'type': 'PROCEDURE', 'description': 'Tandem colonoscopy with different image modalities', 'armGroupLabels': ['BLI', 'NBI', 'WLI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Wai Keung Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'LEUNG Wai Keung', 'investigatorAffiliation': 'The University of Hong Kong'}}}}