Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02791659
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2016-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.
Sponsor:
Organization:
Raw JSON
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The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.\n\nAutomatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Prone', 'description': 'In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.\n\nAutomatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effective Radiation Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Left Lateral Decubitus', 'description': 'In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.\n\nAutomatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.'}, {'id': 'OG001', 'title': 'Prone', 'description': 'In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.\n\nAutomatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0307', 'groupId': 'OG000', 'lowerLimit': '0.0192', 'upperLimit': '0.0437'}, {'value': '0.0192', 'groupId': 'OG001', 'lowerLimit': '0.0115', 'upperLimit': '0.0322'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediate after procedure', 'description': 'The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.', 'unitOfMeasure': 'mSv', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Left Lateral Decubitus', 'description': 'In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.\n\nAutomatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.'}, {'id': 'FG001', 'title': 'Prone', 'description': 'In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.\n\nAutomatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Left Lateral Decubitus', 'description': 'In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.\n\nAutomatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.'}, {'id': 'BG001', 'title': 'Prone', 'description': 'In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.\n\nAutomatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '76.5'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '59', 'upperLimit': '73'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '55.25', 'upperLimit': '75.75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'spread': '3.45', 'groupId': 'BG000'}, {'value': '22.2', 'spread': '4.07', 'groupId': 'BG001'}, {'value': '22.5', 'spread': '3.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Indication for ERCP', 'classes': [{'categories': [{'title': 'Choledocholithiasis', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Malignant biliary obstruction', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Benign biliary obstruction', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Vertical thickness', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '3.71', 'groupId': 'BG000'}, {'value': '20.2', 'spread': '4.18', 'groupId': 'BG001'}, {'value': '23.7', 'spread': '5.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fluoroscopy time', 'classes': [{'categories': [{'measurements': [{'value': '4.06', 'groupId': 'BG000', 'lowerLimit': '2.58', 'upperLimit': '6.10'}, {'value': '4.14', 'groupId': 'BG001', 'lowerLimit': '2.76', 'upperLimit': '5.82'}, {'value': '4.11', 'groupId': 'BG002', 'lowerLimit': '2.58', 'upperLimit': '6.03'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'min', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Dose area product', 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'groupId': 'BG000', 'lowerLimit': '17.55', 'upperLimit': '40.15'}, {'value': '23.2', 'groupId': 'BG001', 'lowerLimit': '16.25', 'upperLimit': '32.10'}, {'value': '22.65', 'groupId': 'BG002', 'lowerLimit': '16.75', 'upperLimit': '37.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Gy-cm2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Patient entrance skin dose', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'BG000', 'lowerLimit': '4.76', 'upperLimit': '7.56'}, {'value': '5.5', 'groupId': 'BG001', 'lowerLimit': '4.88', 'upperLimit': '5.89'}, {'value': '5.6', 'groupId': 'BG002', 'lowerLimit': '4.86', 'upperLimit': '6.72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mGy/min', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2016-06-01', 'resultsFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2016-06-01', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-01', 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective Radiation Dose', 'timeFrame': 'Immediate after procedure', 'description': 'The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radiation exposure', 'ERCP', 'prone', 'left lateral decubitus'], 'conditions': ['Occupational Radiation Exposure']}, 'descriptionModule': {'briefSummary': "X-ray beam produced during endoscopic retrograde cholangiopancreatography (ERCP) affect not only the patient, but the personnel of ERCP team may have the effect from the scattered ray. According to the automatic beam adjustment function, the thicker object (eg. lying left lateral) might produce higher scatter ray than thinner object (eg. lying prone). The investigators evaluate the radiation exposure among ERCP personnel compare between patient's 2 different positions.", 'detailedDescription': "Personal solid-state dosimeters were used to measure the radiation dose on personnel during ERCP procedure. The real-time effective doses were displayed at a monitoring screen. A dosimeter was attached outside thyroid collar of each ERCP team member included of 1st endoscopist, 2nd endoscopist, and nurse anesthetist.\n\nPatients' age, gender, BMI, body thickness, and indications for ERCP were recorded. The patients were randomized into 2 groups by block-of-four. The patients' position was assigned to prone or left lateral decubitus. Each ERCP personnel wore a lead apron and the dosimeter was attached outside the thyroid collar. The ERCP procedure was performed according to the indication in a standard technique. After ERCP procedure, the total fluoroscopic time (minute), fluoroscopy tube voltage (kV), fluoroscopy tube current (mA), patient entrance skin dose (mGy) and personnel effective dose (Sv) from each dosimeter were recorded.\n\nContinuous variables were compared by Student's t-test or Man Whitney U-test, where appropriate. Categorical variables were compared by Chi-square or the Fisher exact test. Statistical analysis was calculated by using SPSS statistical software (version17 for Window, Chicago, USA) and two sided p-value \\< 0.05 was considered to be statistical significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Indicated for ERCP\n\nExclusion Criteria:\n\n* pregnancy\n* American Society of Anesthesiologists (ASA) physical status class III - IV\n* unstable vital signs\n* patients' position needed to be changed during the procedure\n* patients who need fixed position for ERCP (such as biliary hilar lesion)\n* enteroscope-assisted ERCP\n* the consent form can not be obtained"}, 'identificationModule': {'nctId': 'NCT02791659', 'briefTitle': 'Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions.', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Radiation Exposure of ERCP Personnel at Different Standing Locations and Different Patient Positions (Prone and Left Lateral Decubitus)', 'orgStudyIdInfo': {'id': 'PA-E-RAD002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Left lateral decubitus', 'description': 'In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.', 'interventionNames': ['Radiation: Automatic beam adjustment function']}, {'type': 'EXPERIMENTAL', 'label': 'Prone', 'description': 'In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.', 'interventionNames': ['Radiation: Automatic beam adjustment function']}], 'interventions': [{'name': 'Automatic beam adjustment function', 'type': 'RADIATION', 'description': 'The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.', 'armGroupLabels': ['Left lateral decubitus', 'Prone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rungsun Rerknimitr, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}