Gallbladder cancer
Conditions
Interventions
Laparoscopic gallbladder bed resection
Sponsors
International University of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with gallbladder cancer, including cases with suspicious preoperative diagnosis, who will undergo cholecystectomy with lymph node dissection and biliary tract reconstruction, depending on the extent of bile duct invasion. 2) Patients with a performance status of 0-1 who can tolerate surgery. 3) Patients who are judged by the principal investigator or sub-investigator to have sufficient liver function for surgery based on the results of Child-Pugh classification and ICG retention test (within 30 days prior to enrollment). 4) Patients with preoperatively diagnosed as T2 and part of T3 (direct intrahepatic invasion within 5 mm; Hinf1b or less). 5) Patients with no obvious peritoneal dissemination, paraaortic lymph node metastasis, or hepatoduodenal ligament invasion before surgery. 6) Patients must meet the following criteria for major organ function within 30 days prior to enrollment. (a) Bone marrow function: White blood cell: >=3,000/mm3, Neutrophil: >=1,500/mm3 (b) Renal function: Serum creatinine: <= 2 times the upper limit of institutional normal (ULN) 7) Patient must be 20 years of age or older at the time of obtaining consent. 8) Explanations using a prescribed document must be given to the subject, and written consent must be obtained from the subject.
Exclusion criteria
Exclusion criteria: 1) Patients with preoperative diagnosis of peritoneal dissemination, hepatoduodenal mesenteric infiltration, or paraaortic lymph node metastasis. 2) Patients with uncontrolled extrahepatic lesions. 3) Patients with symptomatic brain metastases. 4) Patients with cardiac disease who are symptomatic at the time of enrollment or are undergoing any treatment. Or, patients with past medical history of myocardial infarction within 1 year prior to enrollment. 5) Patients with concurrent multiple cancers or heterogeneous multiple cancers with disease-free period of less than 5 years. However, patients with early-stage cancer that can be expected to be cured by treatment can be enrolled. 6) Patients with severe interstitial pneumonia or pulmonary fibrosis. 7) Patients with serious infectious diseases. 8) Patients with serious complications (renal failure, liver failure, hypertension uncontrolled by drugs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Countries
Japan
Contacts
Public ContactTakuya Minagawa
School of Medicine, International University of Health and Welfare Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Outcome results
None listed