Abstract
BackgroundDespite 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/designThis 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.DiscussionThis 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 registrationClinicalTrial.gov, NCT01456598.
Highlights
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
Through the Korean Laparoscopic Surgical Society (KLASS)-02 randomized clinical trial (RCT), we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure
To the best of our knowledge, this study is the first multicenter randomized clinical trial recruiting a large number of patients to compare laparoscopic D2 lymphadenectomy with open conventional lymphadenectomy in patients preoperatively diagnosed with locally AGC
Summary
To the best of our knowledge, this study is the first multicenter randomized clinical trial recruiting a large number of patients to compare laparoscopic D2 lymphadenectomy with open conventional lymphadenectomy in patients preoperatively diagnosed with locally AGC. The number of patients required for this safety analysis was calculated according to previous RCTs, which reported that the complication rate of D2 lymphadenectomy was 20.9% in an RCT performed by Japanese surgeons, and the limitation of non-inferiority for complications of D2 lymphadenectomy compared with D1 was 12.0% in another Italian RCT [11,25] This protocol includes a plan to stop recruitment and discontinue this RCT if the results of the safety analysis show significant inferiority in the safety of laparoscopic groups relative to the conventional group. All authors have read and approved the final manuscript for publication
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