gastric caner
Conditions
Interventions
Billroth-II
Roux-en-Y
Sponsors
Clinical Study Group of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-1 Primary gastric cancer diagnosed as adenocarcinoma by biopsy. 1-2 Patients who are scheduled for distal gastrectomy for gastric cancer. 1-3 Patients in whom preoperative examination findings suggest that Billroth-I reconstruction is inappropriate, and reconstruction by Billroth-II or Roux-en-Y reconstruction is possible. 1-4 Age 75 years or older 1-5 Performance status 0-2 ECOG classification 1-6 Patients who have been diagnosed as being able to undergo R0 resection. 1-7 Patients who have given written consent to participate in this study. 1-8 Patients who have not undergone previous surgery involving open bowel resection. 1-9 Patients with sufficient bone marrow, liver, and kidney function.
Exclusion criteria
Exclusion criteria: 2-1) Patients with non-curative factors such as peritoneal dissemination, liver metastasis, distant metastasis, or invasion of other organs (T4b) in pre-treatment and preoperative examinations (abdominal CT, abdominal ultrasound, x-ray, etc., in addition to general blood tests). 2-2) Patients with concurrent multiple cancers other than stomach. However, carcinoma in situ of cervical cancer and focal cancer in adenoma of colorectal cancer are not exclusion criteria. 2-3) Patients with heterogeneous multiple cancers that have recurred after treatment or have not passed more than 5 years after treatment. (2-3) Heterogeneous multiple cancers that have recurred after treatment or have not been treated for more than 5 years. 2-4) Patients with emphysema, etc. 2-4) Patients with severe respiratory disorders such as emphysema. 2-5) Patients with a definite history of myocardial infarction. Or cases that can be judged positive by Master two step. 2-6) Cirrhosis or 2-6) Patients with liver cirrhosis or active hepatitis. 2-7) Patients with chronic renal failure requiring dialysis. 2-7) Patients with chronic renal failure requiring dialysis. 2-8) Diabetic patients with poor control (HbA1c: 8.0 or higher). (2-9) Patients who are judged by the investigator to be inappropriate for the safe conduct of the study. 2-10) Patients with reflux esophagitis (LA classification A or higher).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss rate 1 month after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight loss rate at discharge, 3 months, 6 months, and 1 year after surgery Postoperative complications Nutritional status Blood loss, operative time, postoperative hospital stay Frequency of reflux esophagitis, residual gastritis, and dumping Compliance with postoperative adjuvant chemotherapy | — |
Countries
Japan
Contacts
Public ContactKoji Tanaka
Graduate School of Medicine, Osaka University Department of Gastroenterological Surgery
Outcome results
None listed