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, 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

Abstract

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.

Keywords: Laparoscopic surgery; Modified complete mesocolic excision; Oncologic outcomes; Right-sided colon cancer.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart of the study
Fig. 2
Fig. 2
Overview of the modified complete mesocolic excision procedure with the site of the vascular ligation depending on the location of the tumour (red arrow) and the level of central radicality (blue arrow). a Ascending colon cancer: only the right branch of the middle colic artery is ligated. Lymphadenectomy around the origin of the colic artery with complete exposure of the superior mesenteric vein (SMV). b Proximal transverse colon cancer: the root of the middle colic artery is ligated. Lymphadenectomy around the origin of the colic artery with complete exposure of the SMV and the superior mesenteric artery (SMA)
Fig. 3
Fig. 3
Grouping of the retrieved lymph nodes
Fig. 4
Fig. 4
(a) Anterior and (b) posterior photographs of a fresh laparoscopic modified complete mesocolic excision specimen taken with a metric scale. The caecal tumour and ileocolic vascular tie are indicated by forceps. Note the smooth posterior surgical margin and intact peritoneal window

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