Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 5:46 PM
Study NCT ID:
NCT01442506
Status:
UNKNOWN
Last Update Posted:
2011-09-28
First Post:
2011-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acetic Acid Guided Biopsies Compared With High Definition Endoscopy in the Detection of Barrett's Esophagus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-27', 'studyFirstSubmitDate': '2011-09-21', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic yield of targeted biopsies with high definition endoscopy using i scan virtual chromoendoscopy and acetic acid guided biopsies', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acetic acid', 'virtual chromoendosopy'], 'conditions': ["Barrett's Esophagus"]}, 'referencesModule': {'references': [{'pmid': '23953402', 'type': 'DERIVED', 'citation': "Hoffman A, Korczynski O, Tresch A, Hansen T, Rahman F, Goetz M, Murthy S, Galle PR, Kiesslich R. Acetic acid compared with i-scan imaging for detecting Barrett's esophagus: a randomized, comparative trial. Gastrointest Endosc. 2014 Jan;79(1):46-54. doi: 10.1016/j.gie.2013.07.013. Epub 2013 Aug 14."}]}, 'descriptionModule': {'briefSummary': "Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus. Chromoendoscopy after local acetic acid application enables recognition of the mucosal surface architecture. The new available EPKi processor (Pentax, Japan) enables HD+ resolution above HDTV standard. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction with i-Scan or acetic acid to diagnose Barrett's esophagus. The primary endpoint of the current prospective study is to investigate the diagnostic yield of virtual chromoendoscopy using the i scan function as compared to acetic acid chromoendoscopy and 4-quadrant biopsies.\n\nPatients with visible columnar lined lower esophagus (CLE) are included. After standardized PPI therapy (14 days; standard dosage) patients were randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application or i-Scan. Biopsies are taken in a targeted fashion using acetic acid or i scan and afterwards 4-quadrant biopsies are taken.", 'detailedDescription': "Specialized columnar epithelium (SCE) is considered as pathognomonic for Barrett's esophagus and can be recognized by new endoscopic techniques. Aim of the study is to test the efficacy of HD+ endoscopy in conjunction with i-scan (newly developed post processing digital filter) or chromoendoscopy (acetic acid) to diagnose Barrett's esophagus.\n\nPatients with visible columnar lined lower esophagus (CLE) or known Barrett's esophagus are included. After standardized PPI therapy (14 days; standard dosage) patients are randomized at a 1:1 ratio to undergo either chromoendoscopy in conjunction with acetic acid application (10-15ml; 1.5%) or HD+ endoscopy in conjunction with i-scan. Mucosal surface structure within CLE is graduated according to Guelrud's classification (type 1-2: endoscopic prediction: gastric epithelium; type 3-4: Barrett's epithelium). Biopsies are taken in a targeted fashion (type 1-4) in both groups and subsequently 4-quadrant biopsies were taken. Primary outcome analysis's to investigate the diagnostic yield of the different biopsy protocols."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with suspected barrettes esophagus', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with CLE\n* patients with known Barrett's esophagus\n\nExclusion Criteria:\n\n* pregnancy\n* severe coagulopathy\n* known malignancies"}, 'identificationModule': {'nctId': 'NCT01442506', 'briefTitle': "Acetic Acid Guided Biopsies Compared With High Definition Endoscopy in the Detection of Barrett's Esophagus", 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Acetic Acid Guided Biopsies Compared With High Definition Endoscopy', 'orgStudyIdInfo': {'id': '837.237.09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Barrett', 'interventionNames': ['Other: biopsies', 'Other: biopsy']}], 'interventions': [{'name': 'biopsies', 'type': 'OTHER', 'description': 'taking biopsies', 'armGroupLabels': ['Barrett']}, {'name': 'biopsy', 'type': 'OTHER', 'description': 'biopsy', 'armGroupLabels': ['Barrett']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Arthur Hoffman, MD', 'role': 'CONTACT', 'email': 'ahoff66286@aol.com', 'phone': '004915111628399'}], 'facility': 'University of Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Arthur Hoffman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johannes Gutenberg University Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Hoffman Arthur', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}