Multicenter Randomized Controlled Trial for Application of Laparoscopic Total Gastrectomy with Lymph Node Dissection for Gastric Cancer (KLASS-06)

Yonsei University Health System, Severance Hospital0 个研究点目标入组 772 人开始时间: 待定最近更新: 2019年3月11日

试验速览

暂无简介。

•1) Patients who are over 20 and below 80 years old
•2) Patients who have performance status of ECOG 0 or 1
•3) Patients with American Society of Anesthesiology score of class I to III
•4) Patients who are diagnosed with gastric adenocarcinoma not involving Z-line by endoscopy with biopsy
•5) Patients who have primary gastric carcinoma invaded into over muscle propria, and not into adjacent organ in preoperative studies (clinical T2 ~ clinical T4a)
•6) Patients who have no metastasis to lymph nodes or limited metastasis to perigastric lymph node metastasis in preoperative studies (clinical N0 ~ clinical N2)
•7) Patients with tumors which can be curatively resected by total gastretomy with D2 (or D2-#10) lymph node dissection based on preoperative study
•8) Patients who agree with participating in the clinical study with informed consents
•9) Patients who can be followed for at least 3 years after study enrollment

•1) Patients who have possibility of distant metastasis in preoperative studies
•2) Patients who have history of gastric resection with any cause
•3) Patients who have complications (bleeding or obstruction) of gastric cancer
•4) Patients who are treated by chemo(radio)therapy or endoscopic submucosal dissection for gastric cancer
•5) Patients who are diagnosed and treated with other malignancies within 5 years
•6) Vulnerable patients
•7) Patients who participating or participated in other clinical trial within 6 months
•8) Patients who have active synchronous cancer

发起方