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Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial

 Seung Yoon Yang  ;  Min Jung Kim  ;  Bong-Hyeon Kye  ;  Yoon Dae Han  ;  Min Soo Cho  ;  Seung-Yong Jeong  ;  Hyeon-Min Cho  ;  Hyunki Kim  ;  Gyeong Hoon Kang  ;  Seung Ho Song  ;  Jun Seok Park  ;  Ji-Seon Kim  ;  Soo Yeun Park  ;  Jin Kim  ;  Byung Soh Min 
 BMC CANCER, Vol.20(1) : 657, 2020-07 
Journal Title
Issue Date
Laparoscopic surgery ; Modified complete mesocolic excision ; Oncologic outcomes ; Right-sided colon cancer
Background: The 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. Methods: This 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. Discussion: This 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 registration: ClinicalTrials.gov ID: NCT03992599 (June 20, 2019). The posted information will be updated as needed to reflect protocol amendments and study progress.
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1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hyunki(김현기) ORCID logo https://orcid.org/0000-0003-2292-5584
Min, Byung Soh(민병소) ORCID logo https://orcid.org/0000-0003-0180-8565
Yang, Seung Yoon(양승윤) ORCID logo https://orcid.org/0000-0001-8129-7712
Cho, Min Soo(조민수)
Han, Yoon Dae(한윤대) ORCID logo https://orcid.org/0000-0002-2136-3578
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