metabolic syndrome gastric cancer
Conditions
Interventions
Control group: Surgery alone Patient will be performed open gastrectomy/ total gastrectomy or laparoscopy-assisted distal/ toatl gastrectomy within 14 days after registration. Patients will receive
Sponsors
AEGES study group
NPO ECRIN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric cancer (exclude small cell carcinoma) 2) Clinical stage T1N0/T1N1/T2N0, P0, H0, M0 (Japanese Classification of Gastric Carcinoma, the 13th edition) 3) Age 20 to 75 at registration 4) ECOG PS0 5) Can walk over 200m on the flat floor and can walk up to over 2nd floor without interval 6) No ischemic change in the treadmil ECG (within 6weeks before registration) 7) Less than 1 cardiac risk in the following check list(within 4 weeks before registration) 1.History of ischemic heart disease 2.History of heart failure 3.History of cerebrovascular disease 4.Insulin therapy for diabetes 5.Preoperative serum creatinine>2.0mg/dl 8) Less than 2 respiratory risk in the following check list (within 4 weeks before registration) 1.Current smoker within 8 weeks of registration 2.Serum albumin <3.0g/dl 3.Serum BUN>30mg/dl 4.COPD(FEV1.0 of less than 80% of predicted) 9) No liver disease or Child-Pugh A(within 4 weeks before registration) 10) Suffice the following items(within 2 weeks before registration) 1.Hb>9.0g/dl 2.Plt>10x104/mm3 3.AST<100IU and ALT<100IU 11) Suffice the following 3 criteria(within 4 weeks before registration) Waist circumference(WC) Male, height>160cm: WC>85cm Female or height<160cm male: WC>80cm Excessive intraabdominal fat in CT scan Appricable to more than 1 item of the following TG>150mg/dl and/or HDL chol<40mg/dl SBP>130mmHg and/or DBP<85mmHg FBS>110mg/dl (If already medicated for hyperlipidemia, hypertension, or Diabetes Meritus, inclusive to each item regardless of labo data)
Exclusion criteria
Exclusion criteria: 1.Cannot exercise because of muscloskeletal disease 2.History of injury such as fracture within 6 months before registration 3.History or current therapy of bronchial asthma 4.History of severe pneumonia or bronchitis within 6 months before registration 5.History or current therapy of arrythmia to be treated 6.History of acute myocardial infarction within 6 months before registration 7.Uncontrolled DM (Insulin-treated patient is also applicable, if BS control is good.)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Changes from the base-line body weight, HDL cholesterol, operation time, intaoperative blood loss, number of dissected lymph nodes, grade of perioperative complications | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence of perioperative complications | — |
Countries
Japan
Contacts
Public ContactHaruhiko Cho
Kanagawa Cancer Center gastrointestinal surgery
Outcome results
None listed