Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-01-04 @ 12:32 PM
Study NCT ID:
NCT04157803
Status:
UNKNOWN
Last Update Posted:
2019-11-08
First Post:
2019-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-11-01', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Staining behaviour of the polyps after acetic acid: presence or absence of aceto-whitening reaction', 'timeFrame': '1 month', 'description': 'The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa. In case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly. This outcome will be evaluated visually by the involved endoscopist.'}, {'measure': 'Histopathology of resected polyps', 'timeFrame': '1 month', 'description': 'Histopathology of resected polyps defined by the observation of the resected specimen by a trained Pathologist.'}], 'secondaryOutcomes': [{'measure': 'Histopathology impression of the endoscopist without acetic acid after resection.', 'timeFrame': '1 month', 'description': "Diagnostic guess of the endoscopist without acetic acid taking into account the shape of the polyp defined in the Paris classification and Kudo's pitt pattern"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Polyp']}, 'referencesModule': {'references': [{'pmid': '29905183', 'type': 'RESULT', 'citation': 'Popoutchi P, Mota FL, Averbach M, de Menezes MS, Coudry RA. Acetic acid spray contribution in the endoscopic diagnosis of serrated polyposis syndrome. VideoGIE. 2018 Jan 5;3(2):65-67. doi: 10.1016/j.vgie.2017.11.011. eCollection 2018 Feb. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The use of acetic acid in the characterization of polyps, produces a homogeneous white staining in sessile serrated adenomas, but not in tubular or tubulo-villous adenomas, a simple approach to predict polyp histopathology.\n\nTo determine the diagnostic accuracy of the use of acetic acid on tubular and serrated adenomas, during colonoscopy, a prospective diagnostic accuracy study was designed, taking as gold standard the pathological anatomy of the resected polyps.\n\nPolyps found during a colonoscopy with suspicion of sessile serrated adenomas or tubular/tubulo villous will be included.', 'detailedDescription': 'In our experience tubular or tubulovillous adenomas with acetic acid have the same behavior as normal colonic mucosa. When sprayed with acetic acid they stain white, as well as the surrounding mucosa, but with a subsequent rapid loss of the effect. In contrast, serrated adenomas maintain an "aceto-whitening" reaction even though the surrounding normal mucosa loses staining.\n\nThe objectives are to determine the sensitivity and specificity, positive and negative probability coefficients of the positive or negative aceto-whitening reaction on serrated adenomas and tubular-tubulo-villous adenomas.\n\nTo determine the diagnostic accuracy of the use of acetic acid on tubular, tubulo-villous and serrated adenomas a prospective diagnostic accuracy study was designed considering the gold standard as the pathological anatomy of resected polyps.\n\nAs independent variables the presence or absence of aceto-whitening reaction after staining and the diagnostic impression of the endoscopist without acetic acid are considered. The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa.\n\nIn case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly.\n\nPlace: German Hospital, endoscopy unit.\n\nData analysis: the data collected in double-entry tables will be captured to obtain the same sensitivity, specificity and positive or negative probability coefficients.\n\nSample size: 100 polyps.\n\nEstimated duration: 1 month'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with colonic polyps\\> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videoolonoscopy.\n\nExclusion Criteria:\n\n* Known acetic acid allergy\n* Known or documented history of adenomatous or serrated polyposis\n* Patients with inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT04157803', 'acronym': 'Acetic', 'briefTitle': 'Accuracy of aCETIC Acid to Predict Histopathology of Colonic Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Aleman'}, 'officialTitle': 'Accuracy of aCeTIC Acid to Predict Histopathology of Colonic Polyps', 'orgStudyIdInfo': {'id': 'HAleman'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient cohort', 'description': 'Patients with polyps\\> 5mm with suspicion of tubular, tubulovillious or serrated adenomas, found during a videcolonoscopy.', 'interventionNames': ['Diagnostic Test: Acetic acid % spray']}], 'interventions': [{'name': 'Acetic acid % spray', 'type': 'DIAGNOSTIC_TEST', 'description': 'If during a videcolonoscopy a polyp is found with suspicion of tubular, tubulovillious or Serrated adenoma, the endoscopist will proceed to stain it using diffuser and acetic acid at a concentration of 3%. The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa.\n\nIn case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly.', 'armGroupLabels': ['Patient cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1118AAT', 'city': 'CABA', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Christian Ahumada, MD', 'role': 'CONTACT', 'email': 'cahumada@hospitalaleman.com', 'phone': '54 11 4827 7000', 'phoneExt': '2861'}], 'facility': 'Hospital Aleman'}], 'centralContacts': [{'name': 'Federico E Bentolila, MD', 'role': 'CONTACT', 'email': 'fbentolila@hospitalaleman.com', 'phone': '54 11 48277000', 'phoneExt': '2861'}], 'overallOfficials': [{'name': 'Daniel Cimmino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ENDIBA SAGE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Aleman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Federico Bentolila', 'investigatorAffiliation': 'Hospital Aleman'}}}}