A Randomized Controlled Phase II Clinical Trial of Reconstruction method for the Elderly patients with gastric cancer after Distal Gastrectomy; Billroth-II Versus Roux-en-Y reconstructio
- Conditions
- gastric caner
- Registration Number
- JPRN-UMIN000046950
- Lead Sponsor
- Clinical Study Group of Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight loss rate 1 month after surgery
- Secondary Outcome Measures
Name Time Method 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