Hur, Hoon; Lee, Hyun Yong; Lee, Hyuk-Joon; Kim, Min Chan; Hyung, Woo Jin; Park, Young Kyu; Kim, Wook; Han, Sang-Uk
BMC cancer
2015NA ; 15 ( 9 ) :355.
PMID : 25939684
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Hur, Hoon - Department of Surgery, Ajou University Medical Center, Ajou University School of Medicine, 206 Worldcup-ro, Youngtong-gu, Suwon, 443-749, Korea. hhcmc75@naver.com.
Lee, Hyun Yong - Clinical Trial Center, Ajou University Medical Center, Ajou University School of Medicine, Suwon, 443-749, Korea. yhy_lovesolong@hotmail.com.
Lee, Hyuk-Joon - Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, 110-799, Korea. appe98@snu.ac.kr.
Kim, Min Chan - Department of Surgery, Dong-A University College of Medicine, Busan, 602-715, Korea. mckim@dau.ac.kr.
Hyung, Woo Jin - Department of Surgery, Yonsei University College of Medicine, Seoul, 120-749, Korea. wjhyung@yuhs.ac.
Park, Young Kyu - Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, 519-763, Korea. parkyk@jnu.ac.kr.
Kim, Wook - Department of Surgery, The Catholic University, Yeouido St. Mary's Hospital, Seoul, 150-713, Korea. kimwook@catholic.ac.kr.
Han, Sang-Uk - Department of Surgery, Ajou University Medical Center, Ajou University School of Medicine, 206 Worldcup-ro, Youngtong-gu, Suwon, 443-749, Korea. hansu@ajou.ac.kr.
ABSTRACT
BACKGROUND: Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial. METHODS/DESIGN: This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2-cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial. DISCUSSION: This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure. TRIAL REGISTRATION: ClinicalTrial.gov, NCT01456598.
Gastric neoplasm, Laparoscopy, D2 lymphadenectomy, Advanced gastric cancer
MESH
Gastrectomy/*methods, Humans, Laparoscopy, Lymph Node Excision, Lymphatic Metastasis, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Sample Size, Stomach Neoplasms/pathology/*surgery, Treatment Outcome
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