Clinically N0 Resectable Intrahepatic Cholangiocarcinoma intrahepatic cholangiocarcinoma
Conditions
Interventions
Liver Resection or Liver Resection with Regional Lymphadenectomy
Sponsors
Hatano Etsuro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient is deemed operable based on preoperative examinations conducted within 28 days prior to surgery and imaging studies performed within 56 days prior to surgery. To ensure sufficient residual liver function, the ICG-Krem (ICG clearance rate x estimated future liver remnant [%]) must be >= 0.05, as assessed within 56 days prior to surgery (for patients undergoing portal vein embolization, the evaluation should be performed after embolization). 2) The patient must meet all of the following criteria based on assessments conducted within 7 days prior to surgery: 1. Performance status (PS) of 0 or 1 2. No fever of >=38.0 degrees 3.Neutrophil count >=1,500/mm3 4.Platelet count >=100,000/mm3 5.Total bilirubin =<3.0 mg/dL 3) Imaging studies performed within 56 days prior to surgery must confirm the absence of distant metastasis (M0) and the feasibility of macroscopically complete resection (R0 or R1).
Exclusion criteria
Exclusion criteria: 1) Patients who have previously undergone lymph node dissection in the same lymph node stations that are planned for dissection during the current hepatectomy with lymphadenectomy. 2) Patients who have received or are scheduled to receive preoperative chemotherapy or chemoradiotherapy for intrahepatic cholangiocarcinoma. 3) Patients with a history of other primary or metastatic liver cancers. 4) Patients with active malignant neoplasms other than intrahepatic cholangiocarcinoma, including synchronous or metachronous multiple cancers with a disease-free interval of less than 2 years. However, patients with a history of the following cancers will not be considered to have active multiple cancers, even if the disease-free interval is less than 2 years, provided the cancers were pathologically confirmed to have a 5-year relative survival rate of 95% or higher: Gastric cancer (adenocarcinoma, common type): Stage 0-I;Colon cancer (adenocarcinoma): Stage 0-I; Rectal cancer (adenocarcinoma): Stage 0-I; Esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma): Stage 0; Breast cancer (DCIS, LCIS): Stage 0; Breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): Stage 0-IIA; Endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I; Prostate cancer (adenocarcinoma): Stage I-II; Cervical cancer (squamous cell carcinoma): Stage 0; Thyroid cancer (papillary, follicular): Stage I, II, III; Renal cell carcinoma (clear cell, chromophobe): Stage I; Other lesions equivalent to carcinoma in situ (Staging should follow the UICC TNM Classification, 8th edition, or equivalent national guidelines.) 5) Patients with refractory moderate or severe ascites or pleural effusion. 6) Patients with current or a history of hepatic encephalopathy. 7) Patients with a history of gastrointestinal bleeding or active hemoptysis within 28 days before enrollment. 8) Patients with systemic infections requiring treatment (excluding viral hepatitis). 9) Patients who are HIV antibody-positive (testing is not mandatory). 10) Patients with a body temperature of >=38.0 degrees at the time of enrollment. 11) Female patients who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding, and male patients whose partners wish to become pregnant. 12) Patients with psychiatric disorders or symptoms that interfere with daily life and make study participation difficult. 13) Patients who are receiving continuous systemic administration (oral or intravenous) of corticosteroids or other immunosuppressive drugs. 14) Patients with serious comorbidities such as heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, or bowel obstruction. 15) Patients with uncontrolled diabetes mellitus. 16) Patients with unstable angina (new onset or worsening within the past 3 weeks) or a history of myocardial infarction within the past 6 months. 17) Patients with a history of cerebrovascular disease or thromboembolic events within the past 6 months. 18) Patients with uncontrolled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. 19) Patients diagnosed with interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT. 20) Patients who require continuous use of the following drugs: Flucytosine (Ancotil, Domelazine, Alcytosin, Cocor); Phenytoin (Aleviatin, Hydantol, Phenytoin N); Warfarin potassium (Arefarin, Samofalone, Warfa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival: OS | — |
Contacts
Public ContactTomoaki Yoh
Kyoto University Hospital
Outcome results
None listed