Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial.
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
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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrial.gov, NCT01456598.
Department of Surgery, Ajou University Medical Center, Ajou University School of Medicine, 206 Worldcup-ro, Youngtong-gu, Suwon, 443-749, Korea. hhcmc75@naver.com.
Hoon
H
Hur
Clinical Trial Center, Ajou University Medical Center, Ajou University School of Medicine, Suwon, 443-749, Korea. yhy_lovesolong@hotmail.com.
Hyun Yong
HY
Lee
Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, 110-799, Korea. appe98@snu.ac.kr.
Hyuk-Joon
HJ
Lee
Department of Surgery, Dong-A University College of Medicine, Busan, 602-715, Korea. mckim@dau.ac.kr.
Min Chan
MC
Kim
Department of Surgery, Yonsei University College of Medicine, Seoul, 120-749, Korea. wjhyung@yuhs.ac.
Woo Jin
WJ
Hyung
Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun, 519-763, Korea. parkyk@jnu.ac.kr.
Young Kyu
YK
Park
Department of Surgery, The Catholic University, Yeouido St. Mary's Hospital, Seoul, 150-713, Korea. kimwook@catholic.ac.kr.
Wook
W
Kim
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.
Sang-Uk
SU
Han
D005743:Gastrectomy / Q000379:methods*; D006801:Humans; D010535:Laparoscopy; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D018401:Sample Size; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome