Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-03-05 @ 3:09 PM
Study NCT ID:
NCT02144493
Status:
UNKNOWN
Last Update Posted:
2014-05-22
First Post:
2014-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Recurrence of Primary Bile Duct Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004240', 'term': 'Diverticulum'}], 'ancestors': [{'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2014-05-12', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The risk factors for the development of recurrent CBD stone', 'timeFrame': 'retrospective (up to 8 years)', 'description': 'The risk factors for the development of recurrent CBD stone will be assessed by multivariate analysis, based on results of univariate analyses. (statistical method: logistic regression analysis)'}], 'primaryOutcomes': [{'measure': 'The association between existence of periampullary diverticulum and recurrent CBD stone', 'timeFrame': 'retrospective (up to 8 years)', 'description': "The association between existence of periampullary diverticulum and recurrent CBD stone will be assessed by univariate analysis.(unit of analysis: odds ratio, statistical method: Fisher's exact test)"}], 'secondaryOutcomes': [{'measure': 'The association between common bile duct angle and existence of recurrent CBD stone', 'timeFrame': 'retrospective (up to 8 years)', 'description': "The association between common bile duct angle and recurrent CBD stone will be assessed by univariate analysis (unit of analysis: angle, statistical method: student's t test)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['common bile duct stones', 'diverticulum'], 'conditions': ['Common Bile Duct Stones']}, 'referencesModule': {'references': [{'pmid': '16858527', 'type': 'BACKGROUND', 'citation': 'Keizman D, Shalom MI, Konikoff FM. An angulated common bile duct predisposes to recurrent symptomatic bile duct stones after endoscopic stone extraction. Surg Endosc. 2006 Oct;20(10):1594-9. doi: 10.1007/s00464-005-0656-x. Epub 2006 Jul 20.'}, {'pmid': '23924499', 'type': 'BACKGROUND', 'citation': 'Katsinelos P, Chatzimavroudis G, Tziomalos K, Zavos C, Beltsis A, Lazaraki G, Terzoudis S, Kountouras J. Impact of periampullary diverticula on the outcome and fluoroscopy time in endoscopic retrograde cholangiopancreatography. Hepatobiliary Pancreat Dis Int. 2013 Aug;12(4):408-14. doi: 10.1016/s1499-3872(13)60063-6.'}, {'pmid': '18635174', 'type': 'BACKGROUND', 'citation': 'Panteris V, Vezakis A, Filippou G, Filippou D, Karamanolis D, Rizos S. Influence of juxtapapillary diverticula on the success or difficulty of cannulation and complication rate. Gastrointest Endosc. 2008 Nov;68(5):903-10. doi: 10.1016/j.gie.2008.03.1092. Epub 2008 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.', 'detailedDescription': 'Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.\n\nThis study is patient-control setting study. Firstly, from July 2007 through February 2014, all the patients who were performed ERCP will be enrolled. The inclusion criteria is the patients with common bile duct stone. The exclusion criteria is patients with biliary stenosis, PSC, retained GB stone, or who were lost to follow-up. The main outcome is the association between periampullary diverticulum, common bile duct angle, and recurrent CBD stone. This will be evaluated by univariate and multivariate analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were diagnosed as CBD stone or calculous cholangitis will be enrolled. These patients will be divided by patienst with recurrent CBD stone (devlopment of CBD stone after 1 year from the first development of CBD stone) or not .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were performed ERCP due to CBD stone or calculous cholangitis\n\nExclusion Criteria:\n\n* Patients with biliary stricture, PSC, retained GB stone, or who were lost to follow-up.'}, 'identificationModule': {'nctId': 'NCT02144493', 'briefTitle': 'Risk Factors for Recurrence of Primary Bile Duct Stones', 'organization': {'class': 'OTHER', 'fullName': 'Chuncheon Sacred Heart Hospital'}, 'officialTitle': 'Case-control Study of Risk Factors for Recurrence of Primary Bile Duct Stones', 'orgStudyIdInfo': {'id': 'YJH-1'}, 'secondaryIdInfos': [{'id': 'ChuncheonSHH YJH-1', 'type': 'OTHER', 'domain': 'ChuncheonSHH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with recurrent CBD stone', 'interventionNames': ['Other: The existence of periampullary diverticulum', 'Other: CBD angle']}, {'label': 'Patients without recurrent CBD stone', 'interventionNames': ['Other: The existence of periampullary diverticulum', 'Other: CBD angle']}], 'interventions': [{'name': 'The existence of periampullary diverticulum', 'type': 'OTHER', 'description': 'Periampullary diverticulum has been postulated as risk factor of recurrent CBD stone.', 'armGroupLabels': ['Patients with recurrent CBD stone', 'Patients without recurrent CBD stone']}, {'name': 'CBD angle', 'type': 'OTHER', 'description': 'Narrow CBD angle has been postulated as risk factor for the development of recurrent CBD stone', 'armGroupLabels': ['Patients with recurrent CBD stone', 'Patients without recurrent CBD stone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200704', 'city': 'Chuncheon', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Hee Lee', 'role': 'CONTACT', 'email': 'hcslib128@hallym.or.kr', 'phone': '82332405128'}, {'name': 'Chang Seok Bang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jai Hoon Yoon, M.D.,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hyo Sun Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'centralContacts': [{'name': 'Jai Hoon Yoon, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'jaihoonyoon@gmail.com', 'phone': '+821032553957'}], 'overallOfficials': [{'name': 'Jai Hoon Yoon, M.D..Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hallym University College of Medicine, Chuncheon Sacred Heart hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Jai Hoon Yoon', 'investigatorFullName': 'Jai Hoon Yoon', 'investigatorAffiliation': 'Chuncheon Sacred Heart Hospital'}}}}