Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-27 @ 8:37 AM
Study NCT ID:
NCT01737567
Status:
WITHDRAWN
Last Update Posted:
2025-03-27
First Post:
2012-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'similar study is progressing instead', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2012-11-27', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in detection of colorectal adenomas.', 'timeFrame': 'One year', 'description': 'It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.'}], 'secondaryOutcomes': [{'measure': 'Improvement of histological prediction', 'timeFrame': 'One year', 'description': 'It is anticipated that the use of Bright Narrow Band Imaging will significantly improve the histological detection of colonic adenomas when detected as opposed to White Light Endoscopy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colonic Adenomas']}, 'descriptionModule': {'briefSummary': 'Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.', 'detailedDescription': 'Removal of colorectal adenomas prevents occurrence of cancers \\[1\\]. It is recognized that colonoscopy can miss colorectal adenomas and early cancers \\[2\\]. There is a need to further improve performance of colonoscopy. The use of chromoendoscopy has been shown to improve detection of flat adenomas \\[3\\]. Narrow band imaging was introduced in year 2006. It is similar to chromoendoscopy in that it provides more mucosal details. This enables endoscopists to accurately describe the pit pattern of adenomas. NBI has been used as a substitute to chromoendoscopy.\n\nIn pooled analysis, NBI is comparable to chromoendoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas \\[4\\]. Unfortunately, the use of NBI has not been shown to conclusively improve rate of colorectal adenoma detection. Two of 3 randomized trials that compared WLE to NBI showed a higher adenoma detection rate with the use of NBI \\[5, 6\\]. In a study by Rex et al., the rate was however similar with either modality. In a pooled analysis, NBI was only marginally better than WLE \\[7\\].\n\nThe effective use of NBI depends on the quality of bowel preparation and the experience of endoscopist. In the presence of fecal matters, NBI tends to be dark and detection of small adenomas becomes difficult. The prototype bright NBI coupled with high definition resolution is likely to overcome this drawback of original NBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic subjects undergoing screening colonoscopy, age \\> 50, average risk subjects and, ability to provide a written consent to trial participation.\n\nExclusion Criteria:\n\n* personal history of inflammatory bowel disease, colon adenoma or cancer\n* family history of FAP or Familial nonpolyposis syndrome\n* first degree relatives having diagnosed to have colorectal carcinoma\n* no colonoscopy in past 5 years'}, 'identificationModule': {'nctId': 'NCT01737567', 'acronym': 'WLEvB-NBI', 'briefTitle': 'Comparison Between White Light Endoscopy and Bright Narrow Band Imaging in Diagnosis Colonic Adenomas.', 'organization': {'class': 'OTHER', 'fullName': 'Western Sydney Local Health District'}, 'officialTitle': 'A Randomised Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Colonic Adenomas in Asymptomatic Subjects Undergoing Screening Colonoscopy.', 'orgStudyIdInfo': {'id': 'HREC/11/WMEAD/223'}, 'secondaryIdInfos': [{'id': 'HREC2011/12/4.9 (3395)', 'type': 'OTHER', 'domain': 'HREC WSLHD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright Narrow Band Imaging', 'description': 'Use of B-NBI to detect colonic adenomas.', 'interventionNames': ['Other: Bright Narrow Band Imaging.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'White Light Endoscopy', 'description': 'Use of White Light Endoscopy to detect colonic adenomas.', 'interventionNames': ['Other: White Light Endoscopy']}], 'interventions': [{'name': 'Bright Narrow Band Imaging.', 'type': 'OTHER', 'description': 'Using Bright Narrow Band Imaging to detect colonic adenomas.', 'armGroupLabels': ['Bright Narrow Band Imaging']}, {'name': 'White Light Endoscopy', 'type': 'OTHER', 'description': 'Use of White Light Endoscopy to detect colonic adenomas.', 'armGroupLabels': ['White Light Endoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Endoscopy Unit', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Professor Michael Bourke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Gastrointestinal Endoscopy', 'investigatorFullName': 'Professor Michael Bourke', 'investigatorAffiliation': 'Western Sydney Local Health District'}}}}