Nctid:
NCT06612931
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002779", "term"=>"Cholestasis"}, {"id"=>"D003251", "term"=>"Constriction, Pathologic"}], "ancestors"=>[{"id"=>"D020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D001649", "term"=>"Bile Duct Diseases"}, {"id"=>"D001660", "term"=>"Biliary Tract Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M6475", "name"=>"Constriction, Pathologic", "asFound"=>"Stricture", "relevance"=>"HIGH"}, {"id"=>"M6019", "name"=>"Cholestasis", "asFound"=>"Biliary Stricture", "relevance"=>"HIGH"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M4935", "name"=>"Bile Duct Diseases", "relevance"=>"LOW"}, {"id"=>"M4946", "name"=>"Biliary Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>112}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-04-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2024-08-16", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-07-20", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The diagnostic accuracy", "timeFrame"=>"6 months", "description"=>"The accuracy of dual-lumen catheter-guided miniforceps biopsy (CMB) and brush cytology with vacuum aspiration (BCA) in the diagnosis of biliary strictures."}], "secondaryOutcomes"=>[{"measure"=>"the diagnostic sensitivity", "timeFrame"=>"6 months", "description"=>"The diagnostic sensitivity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures."}, {"measure"=>"The diagnostic specificity", "timeFrame"=>"6 months", "description"=>"The diagnostic specificity of dual-lumen catheter-guided mini-forceps biopsy and brush cytology with vacuum aspiration to the suspicious biliary strictures."}, {"measure"=>"Severe adverse events rates", "timeFrame"=>"6 months", "description"=>"The incidence of adverse events, namely, post-ERCP pancreatitis, gastrointestinal perforation, and bleeding were compared."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Endoscopic Retrograde Cholangiopancreatography (ERCP)", "Miniforceps Biopsy", "Biliary Strictures", "Brush Cytology"]}, "descriptionModule"=>{"briefSummary"=>"In this randomized crossover trial involving patients with indeterminate biliary strictures, we aimed to compare the diagnostic performance of the dual-lumen catheter-guided miniforceps biopsy (CMB) device with that of brush cytology under aspiration (BCA)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"88 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged between 18-88 years old.\n* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.\n* Biliary obstructive symptoms,or indeterminate biliary stricture suspected to be intrinsic based on prior imaging.\n\nExclusion Criteria:\n\n* Any contraindications to ERCP.\n* Severe cardiopulmonary disease or coagulopathy.\n* Biliary strictures caused by extrinsic compression.\n* Unwillingness or inability to provide consent.\n* Pregnant or breastfeeding women."}, "identificationModule"=>{"nctId"=>"NCT06612931", "briefTitle"=>"Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures", "organization"=>{"class"=>"OTHER", "fullName"=>"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine"}, "officialTitle"=>"Comparison of Dual-lumen Catheter-guided Mini-forceps Biopsy and Brush Cytology with Vacuum Aspiration in Suspicious Biliary Strictures: a Multicenter, Randomized, Crossover Trial", "orgStudyIdInfo"=>{"id"=>"2022108"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"CMB", "description"=>"In ERCP procedures, catheter-guided mini-forceps biopsy (CMB) is performed before biliary brush cytology with vacuum aspiration (BCA).", "interventionNames"=>["Procedure: Dual-lumen catheter-guided mini-forceps biopsy is performed first"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"BCA", "description"=>"In ERCP procedures, biliary brush cytology with vacuum aspiration (BCA) is performed before dilation catheter-guided mini-forceps biopsy (CMB).", "interventionNames"=>["Procedure: Biliary brush cytology with vacuum aspiration is performed first"]}], "interventions"=>[{"name"=>"Dual-lumen catheter-guided mini-forceps biopsy is performed first", "type"=>"PROCEDURE", "description"=>"In ERCP procedures, catheter-guided mini-forceps biopsy is performed before biliary brush cytology.", "armGroupLabels"=>["CMB"]}, {"name"=>"Biliary brush cytology with vacuum aspiration is performed first", "type"=>"PROCEDURE", "description"=>"In ERCP procedures, biliary brush cytology with vacuum aspiration is performed before dilation catheter-guided mini-forceps biopsy.", "armGroupLabels"=>["BCA"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"201620", "city"=>"Shanghai", "country"=>"China", "facility"=>"Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "overallOfficials"=>[{"name"=>"Baiwen Li, Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Xijing Hospital of Digestive Diseases", "class"=>"OTHER"}, {"name"=>"Eastern Hepatobiliary Surgery Hospital", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Director of the Gastrointestinal Endoscopy Center", "investigatorFullName"=>"Baiwen Li", "investigatorAffiliation"=>"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine"}}}}
