Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT00633620
Status:
COMPLETED
Last Update Posted:
2008-03-12
First Post:
2008-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-11', 'studyFirstSubmitDate': '2008-03-05', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adenoma detection rate (number of polyps/number of patients examined)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'analysis of the total number of polyps, flat/sessile adenomas, small adenomas (< 1 cm), hyperplastic polyps with size determination and right-sided versus left-sided polyp location', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'narrow band imaging', 'adenoma', 'diagnosis', 'colonoscopic adenoma detection'], 'conditions': ['Adenoma']}, 'referencesModule': {'references': [{'pmid': '22056301', 'type': 'DERIVED', 'citation': 'Adler A, Aminalai A, Aschenbeck J, Drossel R, Mayr M, Scheel M, Schroder A, Yenerim T, Wiedenmann B, Gauger U, Roll S, Rosch T. Latest generation, wide-angle, high-definition colonoscopes increase adenoma detection rate. Clin Gastroenterol Hepatol. 2012 Feb;10(2):155-9. doi: 10.1016/j.cgh.2011.10.026. Epub 2011 Nov 2.'}, {'pmid': '19014944', 'type': 'DERIVED', 'citation': 'Adler A, Aschenbeck J, Yenerim T, Mayr M, Aminalai A, Drossel R, Schroder A, Scheel M, Wiedenmann B, Rosch T. Narrow-band versus white-light high definition television endoscopic imaging for screening colonoscopy: a prospective randomized trial. Gastroenterology. 2009 Feb;136(2):410-6.e1; quiz 715. doi: 10.1053/j.gastro.2008.10.022. Epub 2008 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'Narrow Band Imaging (NBI) with high-definition (HDTV) visualization has been implemented into GI endoscopy with the purpose to better highlight endoluminal pathological structures by improving their contrast. Previous studies from referral centers could not show significant differences in terms of colonoscopic adenoma detection rate, but either very high adenoma rates or some numerical differences suggested that some benefit may exist which may become evident with average adenoma rates and/or large case numbers.\n\nIn a prospective randomized trial performed exclusively in a multicenter private practice setting involving 6 examiners with substantial life-time experience (\\>10.000 colonoscopies) 1200 patients will undergo HDTV screening colonoscopy with either NBI or conventional imaging technique on instrument withdrawal. Primary outcome measure is the adenoma detection rate (ADR; i.e. number of adenomas per patient).', 'detailedDescription': 'in 5 private practices with 6 examiners, consecutive asymptomatic persons willing to undergo screening colonoscopy will be asked to participate in this randomized study.\n\nAfter introduction of the colonoscope into the cecum, patients will be randomized into withdrawal with either the NBI mode or conventional imaging by using wide-angle colonoscopes with HDTV imaging (Olympus Corp., Hamburg, Germany) in both groups. Randomization lists will be used for group allocation in each individual practice. In the NBI group, switching back to conventional imaging, and the number of occasions for switching back and the reasons for it are documented in this group.\n\nPatients bowel preparation consists mostly of polyethylene glycol lavage with 4-5 liters until clear rectal fluid is evacuated. All examiners shall take special care to wash and clean the entire large bowel during instrument introduction and withdrawal, in order to provide optimal imaging conditions.\n\nThe following parameters are documented:\n\n* Age and sex of the patient\n* Type and dosage of sedation\n* Examination time, both for instrument introduction and withdrawal\n* Polyp characteristics: size (measured by open forceps or snare), shape (pedunculated/elevated, sessile/flat, and location\n* Polyp histology after removal using snare polypectomy or forceps removal (for polyps \\< 3 mm), or biopsy if there are contraindications\n* Other lesions found such as cancers, diverticula, inflammatory lesions etc. The main outcome parameter is the adenoma detection rate (number of polyps/number of patients examined) in the two groups.\n\nSecondary outcome measures include analysis of the total number of polyps, flat/sessile adenomas, small adenomas (\\< 1 cm), hyperplastic polyps with size determination and right-sided versus left-sided polyp location in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic persons \\> 55 years willing to undergo screening colonoscopy\n\nExclusion Criteria:\n\n* Missing consent\n* Symptomatic persons\n* Poor general conditions, significant comorbidity'}, 'identificationModule': {'nctId': 'NCT00633620', 'acronym': 'BECOP-2', 'briefTitle': 'Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Narrow Band Versus Conventional Endoscopic Imaging for Screening Colonoscopy in a Private Practice Setting - A Large Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'Charite-CVK-Endo-1'}, 'secondaryIdInfos': [{'id': 'Berlin Colonoscopy Project 2'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'colonoscopy', 'description': 'Non-NBI HDTV colonoscopy', 'interventionNames': ['Device: Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)']}], 'interventions': [{'name': 'Olympus NBI colonoscope 180 HDTV narrow band imaging (diagnostic test)', 'type': 'DEVICE', 'otherNames': ['Olympus NBI colonoscope 180 HDTV'], 'description': 'colonoscopy withdrawal with NBI mode', 'armGroupLabels': ['colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité University Hospitals, Campus Virchow Hospital', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Thomas Rösch, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité Medical University Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Thomas Rösch, M.D.', 'oldOrganization': 'Central Interdisciplinary Endoscopy Unit, Charité Berlin, CVK'}}}}