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 reconstruction - 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 reconstruction

Clinical Study Group of Osaka University0 sites100 target enrollmentMarch 1, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 1, 2022

End Date

December 31, 2027

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Clinical Study Group of Osaka University

•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).