Surgical quality assessment for the prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for nonmetastatic right colon cancer(PIONEER study)
Surgical quality assessment for the prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for nonmetastatic right colon cancer(PIONEER study)
Background The modified complete mesocolic excision(mCME)procedure for right-sided colon cancer is a tailored approach based on the original complete mesocolic excision(CME)methodology.Limited studies evaluated the safety and feasibility of laparoscopic mCME using objective surgical quality assessments in patients with right colon can-cer.The objectives of the PIONEER study were to evaluate oncologic outcomes after laparoscopic mCME and to identify optimal clinically relevant endpoints and values for standardizing laparoscopic right colon cancer surgery based on short-term outcomes of procedures performed by expert laparoscopic surgeons.Materials and methods This is an ongoing pro-spective,multi-institutional,single-arm study conducted at five tertiary colorectal cancer centers in South Korea.Study reg-istrants included 250 patients scheduled for laparoscopic mCME with right-sided colon adenocarcinoma(from the appen-dix to the proximal half of the transverse colon).The primary endpoint was 3-year disease-free survival.Secondary out-comes included 3-year overall survival,incidence of morbidity in the first 4 weeks postoperatively,completeness of mCME,central radicality,and distribution of metastatic lymph nodes.Survival data will be available after the final follow-up date(June 2024).Results The postoperative complication rate was 12.9%,with a major complication rate of 2.7%.In 87%of patients,central radicality was achieved with dissection at or beyond the level of complete exposure of the su-perior mesenteric vein.Mesocolic plane resection with an intact mesocolon was achieved in 75.9%of patients,as as-sessed through photographs.Metastatic lymph node distribution varied by tumor location and extent.Seven optimal clini-cally relevant endpoints and values were identified based on the analysis of complications in low-risk patients.Conclu-sions Laparoscopic mCME for right-sided colon cancer produced favorable short-term postoperative outcomes.The identi-fied optimal clinically relevant endpoints and values can serve as a reference for evaluating surgical performance of this procedure.
关键词
改良完整结肠系膜切除术/右半结肠癌/短期疗效/标准手术
Key words
modified complete mesocolic excision/right-sided colon cancer/short-term outcomes/standardized surgery