Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 7:28 AM
Study NCT ID:
NCT00852150
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2009-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is a Reporting System for Gastritis or Duodenitis (Modified Lanza Scale) Reproducible?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005756', 'term': 'Gastritis'}, {'id': 'D004382', 'term': 'Duodenitis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004751', 'term': 'Enteritis'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2009-02-25', 'studyFirstSubmitQcDate': '2009-02-25', 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kappa coefficient for the intra and inter-rater agreement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastritis', 'duodenitis', 'inter-rater reliability', 'intra-rater reliablity', 'gastroscopy', 'duodenoscopy'], 'conditions': ['Gastritis', 'Duodenitis']}, 'descriptionModule': {'briefSummary': 'The modified Lanza scale (Lanza FL, 1984) has been widely utilized to grade the degree of gastritis and duodenitis. However, the inter-rater or intra-rater reproducibility of this scale has never been validated. As a quality improvement program, it is important to study the reproducibility of the scale between different operators and the operators himself.\n\nMethod: During upper endoscopic examinations, one investigator performed the procedure and the second investigator look at the endoscopic image. The degree of gastritis and duodenitis is graded. The results of the grading are blinded to the other investigator.\n\nThe endoscopic video is stored for reassessment to determine the intra-rater reliability. The patient identifier is stored in serial number. The investigator will not retrieve the report of the first assessment during the second assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patient undergoing upper endoscopy after informed consent is obtained', 'healthyVolunteers': False, 'eligibilityCriteria': 'All patients undergo upper endoscopy are included after written informed consent is obtained'}, 'identificationModule': {'nctId': 'NCT00852150', 'briefTitle': 'Is a Reporting System for Gastritis or Duodenitis (Modified Lanza Scale) Reproducible?', 'organization': {'class': 'OTHER', 'fullName': 'Ruttonjee Hospital'}, 'officialTitle': 'Reproducibility of Modified Lanza Scale for the Reporting of Gastritis and Duodenitis', 'orgStudyIdInfo': {'id': 'HKEC 2008-083'}}, 'contactsLocationsModule': {'locations': [{'city': 'Wan Chai', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Ruttonjee Hospital', 'geoPoint': {'lat': 22.28142, 'lon': 114.17258}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Ruttonjee Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Fook Hong Ng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Ruttonjee Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruttonjee Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SMO', 'investigatorFullName': 'Fook-Hong Ng', 'investigatorAffiliation': 'Ruttonjee Hospital'}}}}