A randomized phase Ⅲ trial of complete mesocolic excision com-pared with conventional surgery for right colon cancer:interim analysis of a nationwide multicenter study of the Italian Society of Surgical Oncology Colorectal Cancer Network(CoME-in trial)
A randomized phase Ⅲ trial of complete mesocolic excision com-pared with conventional surgery for right colon cancer:interim analysis of a nationwide multicenter study of the Italian Society of Surgical Oncology Colorectal Cancer Network(CoME-in trial)
Background Although complete mesocolic excision(CME)is supposed to be associated with a higher lymph node(LN)yield,decreased local recurrence,and survival improvement,its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials.Method This is a multicenter,randomized,superiority trial(NCT04871399).The 3-year disease-free survival(DFS)was the primary end point of the study.The secondary end points were safety(duration of operation,perioperative complications,hospital length of stay),oncologic outcomes(number of LNs retrieved,3-and 5-year overall survival,5-year DFS),and surgery quality(specimen length,area and integrity rate of mesentery,length of ileocolic and middle-colic vessels).The trial de-sign required the LN yield to be higher in the CME group at interim analysis.Results Interim data analysis is pre-sented in this report.The study enrolled 258 patients in nine referral centers.The number of LNs retrieved was signifi-cantly higher after CME(25 vs.20;p=0.012).No differences were observed with respect to intra-or post-operative compli-cations,postoperative mortality,or duration of surgery.The hospital stay was even shorter after CME(p=0.039).Quality of surgery indicators were higher in the CME arm of the study.Survival data still were not available.Conclusions In-terim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase periopera-tive complications.The study documented with evidence that quality of surgery and LN yield are higher after CME,and this is essential for continuation of patient recruitment and implementation of an optimal comparison.
万方数据