Nctid:
NCT06222619
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000018281", "term"=>"Cholangiocarcinoma"}, {"id"=>"D000001661", "term"=>"Biliary Tract Neoplasms"}, {"id"=>"D000018285", "term"=>"Klatskin Tumor"}], "ancestors"=>[{"id"=>"D000000230", "term"=>"Adenocarcinoma"}, {"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000001660", "term"=>"Biliary Tract Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M20426", "name"=>"Cholangiocarcinoma", "asFound"=>"Cholangiocarcinoma", "relevance"=>"HIGH"}, {"id"=>"M20430", "name"=>"Klatskin Tumor", "asFound"=>"Perihilar Cholangiocarcinoma", "relevance"=>"HIGH"}, {"id"=>"M4947", "name"=>"Biliary Tract Neoplasms", "asFound"=>"Biliary Tract Cancer", "relevance"=>"HIGH"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M5534", "name"=>"Carcinoma", "relevance"=>"LOW"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "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"}, {"id"=>"T761", "name"=>"Biliary Tract Cancer", "asFound"=>"Biliary Tract Cancer", "relevance"=>"HIGH"}, {"id"=>"T755", "name"=>"Bile Duct Cancer", "asFound"=>"Cholangiocarcinoma", "relevance"=>"HIGH"}, {"id"=>"T3241", "name"=>"Klatskin Tumor", "asFound"=>"Perihilar Cholangiocarcinoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M11110", "name"=>"Liver Extracts", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>136}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2020-01-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-08-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-20", "studyFirstSubmitDate"=>"2024-01-11", "studyFirstSubmitQcDate"=>"2024-01-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2021-08-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Overall survival", "timeFrame"=>"The time from diagnosis until the date of death or last date of follow-up or end of study up to 24 months", "description"=>"Overall survival of each group (A-C)."}], "secondaryOutcomes"=>[{"measure"=>"Recurrence free survival", "timeFrame"=>"The time from surgical resection until the date of recurrence or death or last date of follow-up or end of study up to 24 months", "description"=>"Recurrence free survival of patients who underwent surgical resection"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Biliary Tract Cancer", "Portal Vein Embolization"]}, "descriptionModule"=>{"briefSummary"=>"Portal vein embolization is often recommended to reduce the risk of postoperative liver failure and mortality. In this retrospective cohort study, researchers investigated the effect of portal vein embolization in patients with resectable perihilar cholangiocarcinoma bismuth type III and IV."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients diagnosed with Bismuth type III-IV perihilar cholangiocarcinoma", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. patients with Bismuth type III or IV stricture on radiological examination, including computed tomography (CT) or magnetic resonance cholangiography\n2. patients with perihilar cholangiocarcinoma histologically confirmed by surgical resection or forceps biopsy/brush cytology under endoscopic retrograde cholangiopancreatography or through the percutaneous transhepatic biliary drainage tract.\n\nExclusion Criteria:\n\n1. patients with unresectable perihilar cholangiocarcinoma\n2. patients who refused treatment\n3. patients with other concomitant malignancies."}, "identificationModule"=>{"nctId"=>"NCT06222619", "briefTitle"=>"Effect of PVE on Surgical Outcomes and Long-term Survival in Perihilar Cholangiocarcinoma", "organization"=>{"class"=>"OTHER", "fullName"=>"Seoul National University Hospital"}, "officialTitle"=>"Effect of Portal Vein Embolization on Surgical Outcomes and Long-term Survival in Patients With Perihilar Cholangiocarcinoma", "orgStudyIdInfo"=>{"id"=>"H-2001-092-1095"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Resection without PVE", "description"=>"Resection of bile duct and associated hemi-liver without portal vein embilzation"}, {"label"=>"Resection after PVE", "description"=>"Resection of bile duct and associated hemi-liver after portal vein embilzation", "interventionNames"=>["Procedure: Potal vein embilization"]}, {"label"=>"No resection after PVE", "description"=>"No resection of bile duct and associated hemi-liver after portal vein embilzation", "interventionNames"=>["Procedure: Potal vein embilization"]}], "interventions"=>[{"name"=>"Potal vein embilization", "type"=>"PROCEDURE", "otherNames"=>["Surgical resection"], "description"=>"Portal vein of involved bile duct is embolized to increase the volume of remnant liver.", "armGroupLabels"=>["No resection after PVE", "Resection after PVE"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"03080", "city"=>"Seoul", "country"=>"Korea, Republic of", "facility"=>"Seoul National University Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Seoul National University Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Sang Hyub Lee", "investigatorAffiliation"=>"Seoul National University Hospital"}}}}
