The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial

Jun-Yang Lu, Lai Xu, Hua-Dan Xue, Wei-Xun Zhou, Tao Xu, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Yi Xiao, Jun-Yang Lu, Lai Xu, Hua-Dan Xue, Wei-Xun Zhou, Tao Xu, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Yi Xiao

Abstract

Background: The extent of lymphadenectomy during laparoscopic right colectomy can affect the oncological outcome and the safety of surgery. The principle of complete mesocolic excision (CME) has been gradually accepted and increasingly applied by colorectal surgeons. The aim of this study is to investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve the oncological outcomes of patients with right-sided colon cancers, compared with D2 lymphadenectomy.

Methods/design: The Radical Extent of lympadenectomy: D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) study is a prospective, multicenter, randomized controlled trial in which 1072 eligible patients with right-sided colon cancers will be randomly assigned to the CME group or the D2 dissection group during laparoscopic right colectomy. Inclusion criteria are locally advanced colon cancers situated from the cecum to the right third of the transverse colon and clinically staged as T2-4aN0M0 or TanyN + M0. The primary endpoint of this trial is 3-year disease-free survival. Secondary endpoints include 3-year overall survival, postoperative complication rates, perioperative mortality rates, and rates of positive central lymph nodes (the station 3 nodes).

Discussion: The RELARC trial is a prospective, multicenter, randomized controlled trial that will provide evidence on the optimal extent of lymphadenectomy during laparoscopic right colectomy in terms of better oncological outcome and operation safety.

Trial registration: ClinicalTrials.gov: NCT02619942 . Registered on 29 November 2015.

Keywords: Colon cancer; Complete mesocolic excision; Laparoscopic right colectomy; Oncological outcome.

Figures

Fig. 1
Fig. 1
D2 lymphadenectomy requires dissecting the supplying vessels right of the superior mesenteric vein (SMV) and keeping the covering lymphoadipose tissue of the SMV intact. a Right colic vein. b Pancreas neck. c Henle’s trunk. d Inferior pancreaticoduodenal vein. e Pancreas head. f Duodenum. g Undissected SMV
Fig. 2
Fig. 2
During D2 lymphadenectomy, the supplying vessels are ligated right of the SMV
Fig. 3
Fig. 3
The CME procedure requires cleaning the lymphoadipose tissue on the surface of the SMA and ligating the supplying vessels at their origins. a Right colic artery. b Superior mesenteric vein. c Ileocecal artery and vein
Fig. 4
Fig. 4
After complete removal of the ascending and transverse mesocolon from the roots, the pancreatic head and neck are clearly exposed during the CME procedure. a Pancreas neck. b Henle’s trunk. c Ligated right colic artery. d Pancreas head. e Superior mesenteric vein (surgical trunk). f Ligated ileocecal vessels. g Duodenum

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