Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02543151
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2015-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SpyGlass in Post Liver Transplant Biliary Complications.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedural success rate:', 'timeFrame': '1 year', 'description': 'defined as the proportion of SpyGlass procedures completed where the diagnostic or therapeutic objectives were achieved.'}], 'primaryOutcomes': [{'measure': 'Documentation of biliary ductal changes in post-liver transplant biliary complications.', 'timeFrame': '2 years', 'description': 'The study aim is to describe biliary ductal changes in post-liver transplant presenting biliary complications'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events.', 'timeFrame': '2 years', 'description': 'Secondary outcomes include the description of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Biliary stricture', 'Cholangioscopy', 'Spyglass', 'Liver transplant'], 'conditions': ['Liver Transplant Disorder', 'Biliary Anastomosis Complication']}, 'referencesModule': {'references': [{'pmid': '17466202', 'type': 'BACKGROUND', 'citation': 'Chen YK, Pleskow DK. SpyGlass single-operator peroral cholangiopancreatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video). Gastrointest Endosc. 2007 May;65(6):832-41. doi: 10.1016/j.gie.2007.01.025.'}, {'pmid': '21419408', 'type': 'BACKGROUND', 'citation': 'Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17.'}, {'pmid': '26147492', 'type': 'BACKGROUND', 'citation': 'Tringali A, Lemmers A, Meves V, Terheggen G, Pohl J, Manfredi G, Hafner M, Costamagna G, Deviere J, Neuhaus H, Caillol F, Giovannini M, Hassan C, Dumonceau JM. Intraductal biliopancreatic imaging: European Society of Gastrointestinal Endoscopy (ESGE) technology review. Endoscopy. 2015 Aug;47(8):739-53. doi: 10.1055/s-0034-1392584. Epub 2015 Jul 6.'}, {'pmid': '26117180', 'type': 'BACKGROUND', 'citation': 'Hasan M, Canipe A, Tharian B, Navaneethan U, Varadarajulu S, Hawes R. Digital cholangioscopy-directed removal of a surgical staple from a strictured bile duct. Gastrointest Endosc. 2015 Nov;82(5):958. doi: 10.1016/j.gie.2015.05.035. Epub 2015 Jun 25. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe SpyGlass choledochoscopy in patients with post orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal changes after treatment stents.', 'detailedDescription': 'A prospective observational clinical study to be conducted in Hospital Israelita Albert Einstein, a large open-access, private tertiary referral center.\n\nConsecutive eligible patients with suspected post OLT biliary complications referred to endoscopic retrograde cholangiopancreatography (ERCP) will be considered to SpyGlass as follows.\n\nIn those patients with confirmed biliary stricture, SpyGlass direct choledochoscopy will be performed prior to endoscopic treatment with stents.\n\nAfter final stent removal, choledochoscopy will be repeated to evaluate biliary ductal mucosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to endoscopic management for biliary post liver transplant complication without previous treatment\n\nExclusion Criteria:\n\n* Patients referred to endoscopic management for biliary post liver transplant complication with any previous treatment.\n* Below 18 years of age\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02543151', 'briefTitle': 'SpyGlass in Post Liver Transplant Biliary Complications.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Prospective Evaluation of SpyGlass Direct Visualization System in Post Liver Transplant Biliary Stricture.', 'orgStudyIdInfo': {'id': '1439-11'}, 'secondaryIdInfos': [{'id': '28005314.5.0000.0071', 'type': 'OTHER', 'domain': 'CONEP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SpyGlass Choledochoscopy procedure', 'description': 'Any patient referred to endoscopic management for biliary post liver transplant complication without previous treatment will be submitted to SpyGlass (direct visualization system) choledochoscopy procedure.', 'interventionNames': ['Procedure: SpyGlass (direct visualization system) choledochoscopy']}], 'interventions': [{'name': 'SpyGlass (direct visualization system) choledochoscopy', 'type': 'PROCEDURE', 'description': 'SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment', 'armGroupLabels': ['SpyGlass Choledochoscopy procedure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'ANGELO P FERRARI, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Attending physician'}, {'name': 'FERNANDA P MARTINS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attending physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'FERNANDA PRATA MARTINS', 'investigatorAffiliation': 'Hospital Israelita Albert Einstein'}}}}