Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT05600803
Status:
UNKNOWN
Last Update Posted:
2023-11-27
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection rate', 'timeFrame': 'Until the end of the single-operator cholangioscopy session (up to 20 minutes)', 'description': 'detection rate of intraductal neoplastic lesions in patients with bile duct stones who underwent single-operator cholangioscopy'}], 'secondaryOutcomes': [{'measure': 'Technical success of cholangioscopy', 'timeFrame': 'Up to 15 minutes from the time the endoscope passes through the oral cavity', 'description': 'successful insertion of the cholangioscope through the ampulla of Vater and advancement up to the bifurcation of the biliary tree'}, {'measure': 'Technical success of cholangioscopy-guided biopsy', 'timeFrame': 'Until the end of the single-operator cholangioscopy session (up to 20 minutes)', 'description': 'successful tissue sampling of intraductal superficial lesions under direct visualization'}, {'measure': 'Adverse events', 'timeFrame': 'From the start of endoscopy to the end of the study observation period (at least 12 months)', 'description': 'all adverse events including cholangitis, pancreatitis, perforation, bleeding, and air embolism based on ASGE criteria'}, {'measure': 'Number needed to screen', 'timeFrame': 'From the start of endoscopy to the end of the study observation period (at least 12 months)', 'description': 'the number of persons who would need to be screened to diagnose one neoplastic bile duct lesion in selected patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholangiocarcinoma', 'Bile Duct Neoplasms']}, 'referencesModule': {'references': [{'pmid': '23127575', 'type': 'BACKGROUND', 'citation': 'Moon JH, Terheggen G, Choi HJ, Neuhaus H. Peroral cholangioscopy: diagnostic and therapeutic applications. Gastroenterology. 2013 Feb;144(2):276-282. doi: 10.1053/j.gastro.2012.10.045. Epub 2012 Nov 2. No abstract available.'}, {'pmid': '22178463', 'type': 'BACKGROUND', 'citation': 'Siddiqui AA, Mehendiratta V, Jackson W, Loren DE, Kowalski TE, Eloubeidi MA. Identification of cholangiocarcinoma by using the Spyglass Spyscope system for peroral cholangioscopy and biopsy collection. Clin Gastroenterol Hepatol. 2012 May;10(5):466-71; quiz e48. doi: 10.1016/j.cgh.2011.12.021. Epub 2011 Dec 16.'}, {'pmid': '21762903', 'type': 'BACKGROUND', 'citation': 'Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.'}, {'pmid': '20189503', 'type': 'BACKGROUND', 'citation': 'Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.'}, {'pmid': '12050337', 'type': 'BACKGROUND', 'citation': 'Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Results of screening colonoscopy among persons 40 to 49 years of age. N Engl J Med. 2002 Jun 6;346(23):1781-5. doi: 10.1056/NEJM200206063462304.'}, {'pmid': '34508767', 'type': 'BACKGROUND', 'citation': 'Saraiva MM, Ribeiro T, Ferreira JPS, Boas FV, Afonso J, Santos AL, Parente MPL, Jorge RN, Pereira P, Macedo G. Artificial intelligence for automatic diagnosis of biliary stricture malignancy status in single-operator cholangioscopy: a pilot study. Gastrointest Endosc. 2022 Feb;95(2):339-348. doi: 10.1016/j.gie.2021.08.027. Epub 2021 Sep 8.'}, {'pmid': '33865838', 'type': 'RESULT', 'citation': 'Shin IS, Moon JH, Lee YN, Kim HK, Lee TH, Yang JK, Cha SW, Cho YD, Park SH. Use of peroral cholangioscopy to screen for neoplastic bile duct lesions in patients with bile duct stones (with videos). Gastrointest Endosc. 2021 Oct;94(4):776-785. doi: 10.1016/j.gie.2021.03.997. Epub 2021 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'This is the prospective observational study to explore whether the SpyGlass DS II system could be used to screen early-stage neoplastic bile duct lesions in selected patients.', 'detailedDescription': 'It is difficult to diagnose neoplastic bile duct lesions (including cholangiocarcinomas) via direct endoscopic evaluation of the bile duct. Most evaluations of biliary lesions have used indirect imaging modalities such as CT, MRI, or ERCP. However, CT and MRI do not yield tissue diagnoses, unlike ERCP, although the diagnostic accuracy for the latter remains unsatisfactory. Recently, remarkable advances in cholangioscopic systems have been made. Of the currently available cholangioscopic systems, the SpyGlass (Boston Scientific Co, Natick, Mass, USA) is a disposable cholangioscope permitting 4-way deflected steering by a single operator. We aimed to evaluate the efficacy of single-operator cholangioscopy (SpyGlass DS II system) to screen for neoplastic bile duct lesions in patients with bile duct stones, which is one of the risk factor of cholangiocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We plan to recruit a total of 239 patients, assuming that the detection rate of neoplastic bile duct is about 3.5% by referring to the preceding literature. (one-sample inference for binomial proportions, one-sided test, significance 5%, power 80%)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged \\> 18 years\n2. Patients with risk factors for CCA (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins)\n3. Patients who undergo ERCP for confirmation of CBD clearance\n4. Dilated common bile duct (\\> 10 mm)\n5. Previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation\n\nExclusion Criteria:\n\n1. Presence of biliary tract cancer\n2. Presence of distal CBD stricture\n3. Bleeding tendency (INR\\>1.5 or platelets \\<50000 mm3)\n4. Contraindications of ERCP'}, 'identificationModule': {'nctId': 'NCT05600803', 'briefTitle': 'Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Soonchunhyang University Hospital'}, 'officialTitle': 'Efficacy of Single-operator Cholangioscopy to Screen for Neoplastic Bile Duct Lesions in Patients With Bile Duct Stones', 'orgStudyIdInfo': {'id': 'screeningsoc'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DSOC group', 'description': 'Study subjects are patients who satisfied the inclusion/exclusion criteria and underwent single-operator cholangioscopy.', 'interventionNames': ['Procedure: Single-operator cholangioscopy']}], 'interventions': [{'name': 'Single-operator cholangioscopy', 'type': 'PROCEDURE', 'description': 'SpyGlass (Boston Scientific Co, Marlborough, USA) which enabled the direct visualization of the pancreaticobiliary system for the evaluation of intraductal lesions', 'armGroupLabels': ['DSOC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14584', 'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong Ho Moon, MD, PhD, FASGE, FJGES', 'role': 'CONTACT', 'email': 'jhmoonsch@gmail.com', 'phone': '+82-32-621-5094'}, {'name': 'Il Sang Shin, MD, PhD', 'role': 'CONTACT', 'email': '110554@schmc.ac.kr', 'phone': '+82-32-62-5094'}], 'facility': 'Soonchunhyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}], 'centralContacts': [{'name': 'Jong Ho Moon, MD,PhD,FASGE,FJGES', 'role': 'CONTACT', 'email': 'jhmoonsch@gmail.com', 'phone': '+82-32-62-5094'}, {'name': 'Il Sang Shin, MD,PhD', 'role': 'CONTACT', 'email': '110554@schmc.ac.kr', 'phone': '+82-32-62-5094'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'By sharing and conducting research, we try to share pain and optimize performance through cooperation. Details have not been decided yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, FASGE, FJGES', 'investigatorFullName': 'Jong Ho Moon', 'investigatorAffiliation': 'Soonchunhyang University Hospital'}}}}