Gastric cancer
Conditions
Interventions
Robotic distal gastrectomy (RDG) with lymph node dissection of D1+ or higher, performed under proctor guidance via dual console by surgeons with limited experience performing gastric cancer surgery
Sponsors
Iwate Prefectural Isawa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric adenocarcinoma by endoscopic biopsy. 2) The diagnosis of clinical T1N0. 3) Not indicated for ESD. 4) Distal or total gastrectomy is required for radical resection, and R0 surgery is feasible. 5) No invasion to duodenum. 6) Aged 20 years old or older. 7) Eastern Cooperative Oncology Group performance status of 0 or 1. 8) Body mass index (BMI) is less than 30. 9) No history of upper abdominal surgery except laparoscopic cholecystectomy. 10) No prior chemotherapy, endocrine therapy and/or radiotherapy for any malignancies. 11) Adequate organ functions defined as; i) WBC of 3,000/mm3 or more ii) Platelet count 100,000/mm3 or more iii) AST and/or ALT of 100 IU/L or less iv) T.Bil of 2.0 mg/dL or less v) Creatinine of 1.5 mg/dL or less 12) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies. 2) During pregnancy, within 28 days postpartum, or during lactation. 3) Severe mental disease. 4) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 5) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 6) Poorly controlled hypertension. 7) Uncontrolled diabetes mellitus. 8) Respiratory disease requiring continuous oxygen administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intra-abdominal infectious complications after gastrectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. overall survival, 2. relapse-free survival, 3. completion rate of robotic surgeries, 4. incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactMakoto Hikage
Iwate Prefectural Isawa Hospital Division of Surgery
Outcome results
None listed