Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-09 @ 2:41 AM
Study NCT ID:
NCT02022605
Status:
SUSPENDED
Last Update Posted:
2016-06-09
First Post:
2013-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-08', 'studyFirstSubmitDate': '2013-12-21', 'studyFirstSubmitQcDate': '2013-12-21', 'lastUpdatePostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of selective cannulation in 10min by trainee', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Total time of successful cannulation', 'timeFrame': '2 years'}, {'measure': 'Cumulative success rate of each month', 'timeFrame': '2 years'}, {'measure': 'Performance score of selective cannulation', 'timeFrame': '2 years'}, {'measure': 'Performance score of EST', 'timeFrame': '2 years'}, {'measure': 'Complication rate', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ERCP, trainning, trainees, EMS'], 'conditions': ['Selective Cannulation Rate of Trainees Receiving ERCP Training']}, 'referencesModule': {'references': [{'pmid': '23897401', 'type': 'BACKGROUND', 'citation': "Liao WC, Leung JW, Wang HP, Chang WH, Chu CH, Lin JT, Wilson RE, Lim BS, Leung FW. Coached practice using ERCP mechanical simulator improves trainees' ERCP performance: a randomized controlled trial. Endoscopy. 2013 Oct;45(10):799-805. doi: 10.1055/s-0033-1344224. Epub 2013 Jul 29."}, {'pmid': '20978485', 'type': 'BACKGROUND', 'citation': "Lim BS, Leung JW, Lee J, Yen D, Beckett L, Tancredi D, Leung FW. Effect of ERCP mechanical simulator (EMS) practice on trainees' ERCP performance in the early learning period: US multicenter randomized controlled trial. Am J Gastroenterol. 2011 Feb;106(2):300-6. doi: 10.1038/ajg.2010.411. Epub 2010 Oct 26."}]}, 'descriptionModule': {'briefSummary': "Previous studies have demonstrated that coached EMS practice at the beginning of ERCP training could improve the trainees' skill. However, it is not known whether continuously coached practice using EMS can provide additional benefit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consecutive inpatients with naive papilla undergoing ERCP.\n\nExclusion Criteria:\n\n* history of partial or total gastrectomy (Billroth I/II, Roux-en-Y);\n* duodenal stricture (benign or melignant);\n* ampullary carcinoma;\n* previously failed selective cannulation;\n* chronic pancreatitis with PD stone;\n* minor papilla cannulation;\n* servere diseases of heart, lung, brain and kidney;\n* hemodynamical unstablility;\n* pregnant women;\n* refusal or unable to give written informed consent.'}, 'identificationModule': {'nctId': 'NCT02022605', 'acronym': 'ERCP', 'briefTitle': 'Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Continuously Coached Practice Using EMS on ERCP Performance of Trainees: a Prospectively Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '20131208-4'}, 'secondaryIdInfos': [{'id': '20131208-4', 'type': 'OTHER', 'domain': 'Ethics committee of Xijing Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hands-on EMS training group', 'interventionNames': ['Device: Hands-on EMS training', 'Other: Standard training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard training group', 'interventionNames': ['Other: Standard training']}], 'interventions': [{'name': 'Hands-on EMS training', 'type': 'DEVICE', 'description': 'A trainer (SAH) gave a series of demonstrations of the proper techniques of ERCP step by step on the EMS. The demonstration included selective cannulation, sphincterotomy, guidewire exchange, balloon dilation, stone extraction and stent insertion. Then trainees practiced each technique with hands-on coaching from the trainer on the EMS. Each trainee could repeate the practice with the trainer giving only verbal correction of any errors for about 30min.', 'armGroupLabels': ['Hands-on EMS training group']}, {'name': 'Standard training', 'type': 'OTHER', 'description': 'The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of CBD or PD. During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within 10min, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation.', 'armGroupLabels': ['Hands-on EMS training group', 'Standard training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital of Digestive Diseases', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Yanglin Pan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital of Digestive Diseases.The Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Yanglin Pan', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}