Gallbladder carcinoma
Conditions
Interventions
The clinical outcomes were analyzed and compared between the laparoscopic and the open approach to gallbladder carcinoma.
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients preoperatively diagnosed with gallbladder carcinoma that need gallbladder bed resection, lymphadenectomy of the hepatoduodenal ligament, and biliary reconstruction according to the depth of tumor invasion. 2) Patients with the ECOG Performance Status 0 or 1. 3) Patients who have good liver function according to the results of the Child-Pugh classification and the ICG-R15 test (within 30 days before the registration), and are confirmed to withstand surgical operation by the principal investigator or the sub-investigators. 4) Patients with T2 or part of T3 gallbladder carcinoma, which means that direct invasion of tumor to liver is within 5mm (Hinf 0-1b). 5) Patients with no evidence of peritoneal dissemination, para-aortic lymph node metastasis, or invasion to the hepatoduodenal ligament in preoperative assessment. 6) Patients with sufficient function of important organs within 30 days before the registration: WBC; more than 3,000 /mm3, Neutrophils; more than 1,500 /mm3, serum Creatinine; more than twice the upper limit of normal range. 7) Patients with age over 20 years old at the time of informed consent. 8) Patients who confirmed the written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with evident peritoneal dissemination, invasion to the hepatoduodenal ligament, or para-aortic lymph node metastasis in preoperative assessment. 2) Patients with uncontrollable extrahepatic lesions. 3) Patients with symptomatic metastasis to brain. 4) Patients with symptomatic heart disease or under treatment of heart disease, or with history of myocardial infarction within a year before the registration. 5) Patients with double cancer or history of other malignancy within 5 years after the curative treatment, except for early stage carcinoma that would be completely cured by treatment. 6) Patients with interstitial pneumonia or pulmonary fibrosis. 7) Patients with severe infectious disease. 8) Patients with severe co-existing disease such as renal failure, liver failure, or uncontrollable hypertension. 9) Patients with grade 1-5 peripheral motor neuropathy of peripheral sensory neuropathy according to the CTCAE v4.0 - JCOG. 10) Patients with no intention of contraception, or during pregnancy or the lactation period. 11) Patients with history of severe anaphylaxis. 12) Patients who were diagnosed inadequacy for this study by the principal investigator or the sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative blood loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative time, incidence of conversion to open surgery, postoperative hospital stay, intraoperative accident, postoperative complications, other general morbidities | — |
Countries
Japan
Contacts
Public ContactHiroshi Yagi
Department of surgery, Keio University, school of medicine General surgery
Outcome results
None listed