Long-term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma.

Masaaki Ito,Shigeki Yamaguchi,Koki Otsuka,Masahiko Watanabe,Junji Okuda,Seiichiro Yamamoto,Kenichi Yoshimura,Shoichi Fujii,Japan Society Of Laparoscopic Colorectal Surgery

doi:10.1002/ags3.12333

Abstract

AimTo clarify and evaluate the long‐term outcomes of laparoscopic surgery for clinical stage 0/I rectal carcinoma patients.MethodsThis single‐arm phase II trial involved accredited surgeons from 43 Japanese institutions. Patients were registered preoperatively. The planned sample size was 490. The primary endpoint was overall survival, and long‐term outcomes were evaluated.ResultsA total of 495 patients were registered between February 2008 and August 2010. Eight patients (1.6%) required conversion to open surgery. Sphincter‐preserving procedures were performed in 477 (97%) patients. Positive radial resection margin was found in two (0.4%) patients. Of 490 patients, 22, 314, 38, 115, and one patient had final pathological stages (p‐stage) 0, I, II, III, and IV, respectively. Pathologically, 31.4% (154/490) of the patients did not have p‐stage 0/I. The 5‐year overall survival (OS) rates in p‐stages 0, I, II, and III were 100%, 98%, 97%, and 94%, respectively. The 5‐year OS of all patients at 96.6% (95% CI 94.6‐97.9) was significantly better than the expected 5‐year OS of 81.1% (P < .0001). The 5‐year relapse‐free survival in p‐stages 0, I, II, and III were 100%, 93%, 81%, and 79%, respectively. The 5‐year relapse‐free survival of all patients was 90.1%. Fifty patients (10.2%) had recurrence; lung recurrence was found in 22 patients, local recurrence in 14, liver in seven, distant lymph node in nine, and bone in three.ConclusionsLaparoscopic surgery for clinical stage 0/I rectal carcinoma has feasible long‐term outcomes. (ClinicalTrials.gov No.NCT00635466.)

Highlights

Total mesorectal excision (TME), introduced by Heald and Ryall[1] in the 1980s, has remained the gold standard surgical treatment for rectal cancer
The COLOR II trial and COREAN trial successfully showed that laparoscopic surgery in rectal cancer patients had similar locoregional recurrence, disease-free survival (DFS), and overall survival (OS) rates to open surgery.[9,10]
Two recent randomized trials showed that positive circumferential resection rate (CRM) in the laparoscopic surgery group was higher than that in the open surgery group for rectal cancer, and whether laparoscopic surgery for rectal cancer has feasible long-term survival remains to be discussed

Summary

Introduction

Total mesorectal excision (TME), introduced by Heald and Ryall[1] in the 1980s, has remained the gold standard surgical treatment for rectal cancer. Laparoscopic surgery for colon cancer had equal long-term survival rates to open surgery as well as favorable short-term outcomes. The COLOR II trial and COREAN trial successfully showed that laparoscopic surgery in rectal cancer patients had similar locoregional recurrence, disease-free survival (DFS), and OS rates to open surgery.[9,10]. Two recent randomized trials showed that positive circumferential resection rate (CRM) in the laparoscopic surgery group was higher than that in the open surgery group for rectal cancer, and whether laparoscopic surgery for rectal cancer has feasible long-term survival remains to be discussed. Laparoscopic rectal excision has technically demanding aspects, which might be the reasons for the higher anastomotic leakage rate or worse curative resection rate in case of stage II/III rectal cancer with estimated CRM < 1 mm.[11]

Objectives

Methods

Findings

Conclusion