Abstract
BackgroundThe introduction of complete mesocolic excision (CME) with central vascular ligation (CVL) for right-sided colon cancer has improved the oncologic outcomes. Recently, we have introduced a modified CME (mCME) procedure that keeps the same principles as the originally described CME but with a more tailored approach. Some retrospective studies have reported the favourable oncologic outcomes of laparoscopic mCME for right-sided colon cancer; however, no prospective multicentre study has yet been conducted.MethodsThis study is a multi-institutional, prospective, single-arm study evaluating the oncologic outcomes of laparoscopic mCME for adenocarcinoma arising from the right side of the colon. A total of 250 patients will be recruited from five tertiary referral centres in South Korea. The primary outcome of this study is 3-year disease-free survival. Secondary outcome measures include 3-year overall survival, incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes. The quality of laparoscopic mCME will be assessed on the basis of photographs of the surgical specimen and the operation field after the completion of lymph node dissection.DiscussionThis is a prospective multicentre study to evaluate the oncologic outcomes of laparoscopic mCME for right-sided colon cancer. To the best of our knowledge, this will be the first study to prospectively and objectively assess the quality of laparoscopic mCME. The results will provide more evidence about oncologic outcomes with respect to the quality of laparoscopic mCME in right-sided colon cancer.Trial registrationClinicalTrials.gov ID: NCT03992599 (June 20, 2019). The posted information will be updated as needed to reflect protocol amendments and study progress.
Highlights
The introduction of complete mesocolic excision (CME) with central vascular ligation (CVL) for rightsided colon cancer has improved the oncologic outcomes
Yang et al BMC Cancer (2020) 20:657 (Continued from previous page). This is a prospective multicentre study to evaluate the oncologic outcomes of laparoscopic modified CME (mCME) for right-sided colon cancer
The technical details may differ between CME with CVL and Japanese D3 dissection, as demonstrated by differences in the length of resected bowels and the area of the excised mesocolon, which seem to result from different definitions of an adequate resection margin [7]
Summary
Study design This is a multi-institutional, prospective, single-arm study. The duration of the study will be approximately 5 years (2 years of inclusion, 3 years of follow-up). Sample size considerations On the basis of previous data, the median 3-year disease-free survival (DFS) rate after CME for rightsided colon cancer is estimated to be approximately 80%, and the null hypothesis is a 3-years DFS rate after laparoscopic mCME for right-sided colon cancer of at least 88% [12, 13]. This will be assessed using an exact p-value of 0.025 and a power of 0.90 based on the Clopper-Pearson method. All results will be recorded and evaluated by a specialist
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