Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-01-01 @ 6:54 PM
Study NCT ID:
NCT03550768
Status:
COMPLETED
Last Update Posted:
2019-12-26
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 658}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-ERCP pancreatitis incidence', 'timeFrame': '48 hours', 'description': 'frequency of post-ERCP pancreatitis'}], 'secondaryOutcomes': [{'measure': 'Rate of difficult cannulation', 'timeFrame': '3 hours', 'description': 'difficult cannulation was defined as when total cannulation time was more than 5minutes, total cannulation attempts more than 5 times or inadvertent pancreatic duct cannulation more than 1 time.'}, {'measure': 'Cannulation attempts', 'timeFrame': '3 hours', 'description': 'the sphincterotome touching the papilla for at least 5 seconds will be considered as one attempt.'}, {'measure': 'Total cannulation time', 'timeFrame': '3 hours', 'description': 'the time from the moment the sphincterotome touch the papilla to the guide wire advance into the target duct.'}, {'measure': 'Unintended pancreatic duct cannulation', 'timeFrame': '3 hours', 'description': 'the guide wire unintentionally entered into the undesired pancreatic duct'}, {'measure': 'Complication rate', 'timeFrame': '48 hours', 'description': 'frequency of any adverse outcome that required hospital admission or prolonged hospital stay necessary for management of the complication, including pancreatitis, bleeding, biliary infection or perforation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERCP', 'anatomy of major duodenal papilla'], 'conditions': ['Pancreaticobiilary Diseases', 'Endoscopic Retrograde Cholangiopancreatography']}, 'referencesModule': {'references': [{'pmid': '32511794', 'type': 'DERIVED', 'citation': 'Wang X, Zhao J, Wang L, Ning B, Zeng W, Tao Q, Ren G, Liang S, Luo H, Wang B, Farrell JJ, Pan Y, Guo X, Wu K. Relationship between papilla-related variables and post endoscopic retrograde cholangiopancreatography pancreatitis: A multicenter, prospective study. J Gastroenterol Hepatol. 2020 Dec;35(12):2184-2191. doi: 10.1111/jgh.15135. Epub 2020 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'Selective cannulation is an essential step for the success of ERCP. The successful cannulation is influenced by types of disease (such as Sphincter of Oddi Dysfunction and duodenal stricture), the experience of endoscopists and the anatomy of papilla. It is suggested that the size, morphology, orientation and location of major duodenal papilla (MDP), could cause a difficult cannulation (Endoscopy 2016; 48: 657-683). However, the related evidences are limited. The investigators hypothesized that special anatomy of papilla, such as a lanky shape (defined by the higher ratio of length to width) and a deeper location, could increase the difficulty of cannulation. Here the investigators investigated the effects of the anatomy of major duodenal papilla on post-ERCP pancreatitis and the procedure of cannulation in patients undergoing ERCP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with native papilla who underwent ERCP', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-80\n* Patients with native papilla who underwent ERCP\n\nExclusion Criteria:\n\n* Prior endoscopic sphincterotomy\n* Minor pancreatic duct as the targeted duct\n* History of prior upper gastrointestinal surgery, such as Billroth I, II and Roux-en-Y\n* Fistula of MDP\n* Papillary carcinoma or adenoma\n* Duodenal obstruction, type II\n* Prior stent placement in common bile duct or pancreatic duct\n* Pregnant or breastfeeding women\n* Unwilling or inability to provide consent'}, 'identificationModule': {'nctId': 'NCT03550768', 'briefTitle': 'Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Anatomy of Major Duodenal Papilla on the Difficulty of Cannulation During Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'orgStudyIdInfo': {'id': 'KY20180081-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MDP', 'description': 'ERCP was performed by trainees or trainers. Before the cannulation, the photo of major duodenal papilla will be taken carefully to evaluate its size, morphology, orientation and location. All patients initially received wire-guided cannulation with a sphincterotome, If cannulation failed, precut sphincterotomy or the double-wire technique was performed when appropriate. Therapeutic manipulation (eg, sphincterotomy, balloon dilation, stone extraction, and stenting) was done when appropriate. Pancreatic duct stent placement was performed at the discretion of the endoscopists.', 'interventionNames': ['Other: MDP']}], 'interventions': [{'name': 'MDP', 'type': 'OTHER', 'description': 'evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP', 'armGroupLabels': ['MDP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361001', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Department of gastroenterology, Successful Hospital of Xiamen university', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '475000', 'city': 'Kaifeng', 'state': 'Henan', 'country': 'China', 'facility': 'Huaihe Hospital of Henan University', 'geoPoint': {'lat': 34.7986, 'lon': 114.30742}}, {'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Endoscopic center, Xijing Hospital of Digestive Diseases', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '400010', 'city': 'Chongqing', 'country': 'China', 'facility': 'Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, {'name': 'Huaihe Hospital of Henan University', 'class': 'OTHER'}, {'name': 'Successful Hospital of Xiamen university', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yanglin Pan', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}