klatskin tumor, gallbladder neoplasms klatskin tumor, gallbladder neoplasms
Conditions
Interventions
Sponsors
Mizuno Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria 1. The patient is clinically diagnosed with either ( perihilar cholangiocarcinoma (including intraductal papillary neoplasm of the bile duct) or (2) gall bladder cancer. For perihilar cholangiocarcinoma, pathological confirmation of malignancy is require d. For cases of intrahepatic cholangiocarcinoma p rimarily involving the liver but extending to the he patic hilum (i.e., perihilar cholangiocarcinoma in a broad sense) or gallbladder cancer, preoperative histological diagnosis is often difficult. Therefore, cases judged to be gallbladder cancer based on c omprehensive assessment including imaging findings - without requiring definitive preoperative histological confirmation - may also be included. 2. Based on preoperative imaging, the tumor is de emed resectable with curative intent, and one of t he following surgical procedures is applicable: For perihilar cholangiocarcinoma: extrahepatic bile duct resection and hepatectomy. For gallbladder cancer: gallbladder bed resectio n or limited hepatectomy with regional lymphadenectomy.* 3.The patient is deemed suitable to undergo surg ery under general anesthesia. 4.The patient is expected to have a life expectanc y of at least one year. 5.The patient is 18 years of age or older. 6.The patient has received adequate explanation regarding participation in this study and has volun tarily provided written informed consent after fully understanding the study. * For gallbladder cancer with extrahepatic bile duc t invasion, addition of extrahepatic bile duct resec tion and reconstruction is permitted.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1.Patients with confirmed distant metastases. 2.Patients who are determined to require hepate ctomy with hepatic artery resection and reconstru ction and/or portal vein resection and reconstruction. 3.Patients who are determined to require additio nal pancreatoduodenectomy (i.e., hepatopancreat oduodenectomy). 4.Patients with an estimated future liver remnant (FLR) volume less than 40% of total liver volume. 5.Patients with an estimated future liver remnant indocyanine green clearance rate (ICG-KF) of less than 0.05. 6.Patients diagnosed with gallbladder cancer limi ted to T1a invasion, for whom cholecystectomy al one is indicated. 7.Patients deemed inappropriate for inclusion in this study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile (intraoperative complication accordi ng to the ClassINTRA criteria and grade III or high er postoperative complications according to the C lavien-Dindo classification within 30 days after sur gery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation time, operative blood loss, conversion r ate, reopration, number of lymph nodes retrival, p ostoperative length of stay, histological margin sta tus, the rate of recurrence within 1year after resect ion | — |
Contacts
Public ContactTakashi Mizuno
Nagoya University Hospital
Outcome results
None listed