Gastric cancer
Conditions
Interventions
Robot assisted gastrectomy using fluorescence navigation by gastric submucosal injection of ICG.
Sponsors
Tokyo Metropolitan Tama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients diagnosed as clinical stage I and cT1 gastric cancer by preoperative examination. (2)PS (ECOG) is 0 or 1. (3)Body mass index (BMI) is less than 30. (4)Patients without poorly controlled complications. (5)No history of chemotherapy (including endocrine therapy) and/or radiotherapy for any carcinomas. (6)It satisfies all the conditions below. (The latest examination value within 60 days before registration is used for all examination items.) a)WBC >= 3,000 / mm 3 b)Plt >= 100,000 / mm 3 c)AST <= 100 IU / L, ALT <= 100 IU / L d)T.Bil <= 2.0 g / dl e)Serum creatinine <= 1.5 mg / dl (7)The patient himself / herself signed the consent form approved by the ethics committee.
Exclusion criteria
Exclusion criteria: (1) Patients with active multiple primary cancers (simultaneous or metachronous with disease-free period within 5 years). (2) Patients who have a history of frequent laparotomy and are expected to have severe intraperitoneal adhesions. (3) Patients with a history of ICG hypersensitivity. (4) Patients with severe complications (liver disease, renal disease, heart disease, blood disease, metabolic disease). (5) Possible pregnancy or lactating female patients. (6) Patients undergoing continuous systemic administration (ingestion or intravenous) of corticosteroids. (7) Patients who are complicated of psychosis or psychiatric symptoms and judged to be difficult to participate in the exam. (8) Patients judged inappropriate for participation in this study by the research director.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative complication rate of Grade 2 or higher according to Clavien-Dindo classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| Completion rate of robot assisted gastrectomy, operation time, volume of blood loss, intraoperative complication rate of Grade 3 or higher according to CTCAE classification, Postoperative complication rate of Grade 3 or higher according to Clavien-Dindo classification, postoperative course evaluated by Inflammatory findings (WBC, CRP), body temperature, drain amylase value, number of days to post-operative flatus, postoperative hospital days), presence or absence of malignant tumor on dissected resected surface in pathological examination, number of excised lymph nodes. | — |
Countries
Japan
Contacts
Public ContactKazuhiro Imamura
Tokyo Meropolitan Tama Medical Center Department of Surgery
Outcome results
None listed