[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638748":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":24,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":24,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":24,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Resection of the extrahepatic bile duct with thorough lymph node dissection","PLACEBO_COMPARATOR","In cholangiocarcinoma surgery after induction therapy, the extrahepatic bile duct is resected and a thorough lymph node dissection of the hepatoduodenal ligament and the posterior pancreatic head is performed.",[13],"Other: surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Extrahepatic bile duct preservation with hepatoduodenal ligament","EXPERIMENTAL","Extrahepatic bile duct preservation with hepatoduodenal ligament and retropancreatic lymph node dissection.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"surgery","This study aims to investigate the lymph node dissection approach for surgically resected cholangiocarcinoma following induction therapy, to establish criteria for evaluating surgical indications, and to provide a basis for surgical treatment strategies in patients with cholangiocarcinoma.",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Li Huikai, MD","CONTACT","18622228639","tjchlhk@126.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Tianjin Cancer Hospital Airport Hospital","RECRUITING","Tianjin","Tianjin Municipality","300308","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.17667,39.14222,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},{"type":49,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100638748","surgical-total-clearance-versus-extrahepatic-bile-duct-preservation-for-biliary-tract-malignancies-a-single-center-randomized-two-arm-prospective-phase-ii-clinical-trial-100638748",false,"NCT07609641","Surgical Total Clearance Versus Extrahepatic Bile Duct Preservation for Biliary Tract Malignancies: A Single-Center, Randomized, Two-Arm, Prospective Phase II Clinical Trial","Inclusion Criteria:\n\n* Age 18 years or older, regardless of gender.\n\nVoluntary participation with full informed consent; signed written informed consent form; good compliance.\n\nHistologically or cytologically confirmed cholangiocarcinoma (CCA).\n\nGallbladder cancer or intrahepatic cholangiocarcinoma with preoperative lymph node metastasis.\n\nNo prior systemic chemotherapy, immunotherapy, targeted therapy, or local treatment for CCA (including but not limited to transarterial chemoembolization, arterial embolization, arterial infusion chemotherapy, and radioactive particle embolization).\n\nAt least one measurable lesion according to RECIST v1.1.\n\nChild-Pugh class A liver function, and no history of hepatic encephalopathy.\n\nEastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.\n\nLife expectancy ≥ 12 weeks.\n\nAdequate organ function meeting the following requirements (no blood transfusion, blood products, hematopoietic growth factors, or other medications to correct blood counts within 14 days prior to randomization):\n\nWhite blood cell count ≥ 4.0 × 10⁹\u002FL;\n\nAbsolute neutrophil count ≥ 1.5 × 10⁹\u002FL;\n\nPlatelet count ≥ 90 × 10⁹\u002FL;\n\nHemoglobin ≥ 90 g\u002FL;\n\nSerum albumin ≥ 30 g\u002FL;\n\nSerum total bilirubin ≤ 2 × upper limit of normal (ULN); any biliary obstruction must be resolved before randomization;\n\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n\nCreatinine clearance (CrCl) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n\nInternational normalized ratio (INR) ≤ 2 and prothrombin time (PT) prolonged ≤ 3 seconds above the ULN.\n\nFor active hepatitis B, effective antiviral therapy (per local standard of care, e.g., entecavir or tenofovir) is required, with HBV DNA \\\u003C 2000 IU\u002FmL or a ≥ 10-fold decrease in HBV DNA after antiviral treatment; patients must agree to continue effective anti-HBV therapy throughout the study period.\n\nWithin 7 days prior to randomization, women of childbearing potential must have a negative serum pregnancy test and agree to use effective contraception during the study treatment period and for 6 months after the last dose. In this protocol, a woman of childbearing potential is defined as a sexually mature woman who: 1) has not undergone hysterectomy or bilateral oophorectomy; 2) has not been naturally postmenopausal for at least 24 consecutive months (amenorrhea following cancer therapy does not rule out fertility) (i.e., has had menses at any time in the preceding 24 consecutive months). Male patients with female partners of childbearing potential must agree to use effective contraception during the study treatment period and for 5 months after the last dose.\n\nExclusion Criteria:\n\n* Histopathologically or cytologically confirmed hepatocellular carcinoma, mixed hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.\n\nOther malignancy within 5 years, except for cured localized tumors, including non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma.\n\nRadiotherapy for CCA within 4 weeks prior to randomization; major surgery (excluding diagnostic biopsy) within 4 weeks prior to randomization.\n\nHistory of severe cardiovascular or cerebrovascular disease:\n\nNew York Heart Association (NYHA) class II or greater congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmia, or cerebrovascular accident within 12 months prior to randomization;\n\nLeft ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography;\n\nCorrected QT interval (QTc) \\> 480 ms (calculated using the Fridericia method; if QTc is abnormal, it may be measured three times consecutively at 2-minute intervals, and the average taken);\n\nPoorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg, based on the average of ≥ 2 readings);\n\nPrior hypertensive crisis or hypertensive encephalopathy.\n\nEvidence of significant bleeding\u002Fcoagulation disorder or bleeding tendency:\n\nClinically significant hemoptysis or tumor bleeding of any cause within 4 weeks prior to randomization;\n\nPrior tumor rupture (unless surgically treated);\n\nThrombotic or embolic event within 6 months prior to randomization;\n\nTherapeutic anticoagulation within 2 weeks prior to randomization (except for low-molecular-weight heparin);\n\nNeed for antiplatelet therapy;\n\nUse of aspirin (\\> 325 mg\u002Fday), clopidogrel (\\> 75 mg\u002Fday), dipyridamole, ticlopidine, or cilostazol within 10 days prior to randomization.\n\nKnown central nervous system metastasis and\u002For meningeal metastasis (including dural and leptomeningeal metastasis).\n\nAny other condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.","ALL","18 Years","80 Years",{"count":60,"type":61},60,"ESTIMATED","INTERVENTIONAL",[64],"NA","When lymph node dissection of stations 12 and 13 is performed, resecting the bile duct from the superior portion of the pancreas to the confluence of the right and left hepatic ducts allows complete removal of the station 12 and 13 lymph nodes. Preserving the bile duct from the superior pancreas to the hepatic confluence, however, makes a skeletonizing dissection of the duct impossible in order to safeguard the biliary blood supply, inevitably leaving behind a small amount of periductal lymphoid tissue. This results in incomplete lymph node clearance, which may increase the risk of postoperative recurrence and reduce the R0 resection rate.\n\nThis study aims to investigate the lymph node dissection approach for surgically resected cholangiocarcinoma following induction therapy, to establish criteria for evaluating surgical indications, and to provide a basis for surgical treatment strategies in patients with cholangiocarcinoma.",[67],"BTC",[67],"2026-05-20",{"date":71,"type":72},"2026-05-27","ACTUAL",{"date":74,"type":72},"2025-10-20",{"date":76,"type":61},"2027-12-31",{"name":5,"class":6},1]