gastric cancer
Conditions
Interventions
laparoscopic gastrectomy with D2 lymph node dissection
Sponsors
Tochigi Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically proven adenocarcinoma. (2) Clinical T1N1/N2 or cT3N0/N1/N2 by imaging. (3) Tumor located in the middle or lower third of the stomach, and curative resection is expected to be achievable by distal gastrectomy. (4) The macroscopic tumor type neither Borrmann type 4 nor large (8cm or more) type 3 (5) No bulky lymph nodes (>=3 cm x 1 or >=1.5 cm x 2 in major axis) along the celiac, splenic, common or proper hepatic arteries, or the superior mesenteric vein by contrast-enhanced abdominal computed tomography. (6) No distant metastasis based on contrast-enhanced thoracic/abdominal/pelvic CT. (7) No duodenal invasion (8) Age between 20 and 80 years old (9) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. (10) Body Mass Index (BMI) <30 (11) No history of intestinal resection except appendectomy and cholecystectomy (12) No prior chemotherapy, radiotherapy or endocrine therapy (13) Without main organ failure (14) Adequate organ functions defined as indicated below; (a) WBC >= 3,000/mm3 (b) Platelet >= 100,000/mm3 (c) AST <= 100IU/L , ALT <= 100IU/L (d) Total bilirubin <= 2.0 mg/dL (e) Creatinine <= 1.5 mg/dL (15) Written informed consent (16) Patients evaluated to be adequate to participate in this study by the conference in our center.
Exclusion criteria
Exclusion criteria: (1) History of upper abdominal surgery. (2) Insufficient oral intake. (3) With active infectious disease requiring systemic treatment. (4) The body temperature of 38 degrees Celsius or higher. (5) Pregnant or possibly pregnant, or lactating female (6) Impossible to register for the study due to a psychological disorder by a physician in charge's decision (7) Under continuous steroids medication (8) With unstable angina pectoris within three weeks or history of myocardial infarction within six months (9) With uncontrollable blood hypertension (10) With uncontrollable diabetes mellitus or routine administration of insulin (11) With pulmonary disease and require continuous oxygen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of intra-abdominal infectious complications (anastomotic leakage, pancreatic fistula, and intra-abdominal abscess) | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of conversion to open surgery, and the incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactNoriko Oshima
Tochigi Cancer Center Department of Esophageal and Gastric surgery
Outcome results
None listed