A multi-center randomized controlled trial comparing the safety between reduced-port and conventional laparoscopic distal gastrectomy for early gastric cancer (KLASS-12)

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 348 人开始时间: 待定最近更新: 2022年9月20日

适应症

试验速览

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•1) Patients diagnosed with adenocarcinoma in endoscopic biopsy before surgery.
•2) Patients aged 20 to 85 years old.
•3) Patients with a clinical stage evaluated by preoperative endoscopy (or endoscopic ultrasound) and CT examination with T1N0M0 by 8th AJCC gastric cancer staging system
•4) Laparoscopic distal gastrectomy and lymph node resection above D1+ are scheduled, and patients who can undergo radical surgery by this procedure.
•5) A patient who fully explained the purpose and contents of the test before participating in the test and signed a written consent form approved by the Institutional Research Ethics Review Committee to participate in this study according to his free will.

•1) History of abdominal surgery including gastrectomy (excluding laparoscopic appendectomy and laparoscopic cholecystectomy)
•2) If combine resection is expected (Cholecystectomy is possible)
•3) A patient who received chemotherapy or radiation treatment before surgery for gastric cancer diagnosed this time.
•4) Patients who underwent surgery or chemotherapy for other organ primary cancer within the last 5 years (excluding completely cured skin basal cell carcinoma and in situ cervical cancer)
•5) Vulnerable subjects (those who lack medical ability, pregnant women, or those who are planning to conceive)
•6) Patients who have participated in other clinical trials within the last 6 months or are currently participating

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