Endoluminal locoregional resection versus laparoscopic total mesorectal excision for t2 rectal cancer after neoadjuvant therapy: a randomized clinical trial

Abstract

Background: locoregional excision combined with neoadjuvant therapy may be an alternative treatment option to total mesorectal excision (TME) in selected patients with early low rectal cancer. Methods: endoluminal locoregional resection (ELRR) by transanal endoscopic microsurgery and laparoscopic TME were compared in a prospective randomized trial. Patients with rectal cancer staged clinically as cT2 N0 M0, histological grade G1-2, tumour less than 3 cm in diameter, within 6 cm from the anal verge were randomized to ELRR or TME after long course neoadjuvant chemoradiotherapy. All statistical analyses were performed using SAS®version 9.1 (SAS Institute, Cary, North Carolina, USA). The Wilcoxon rank sum test was used to evaluate differences in continuous data between the two surgical procedures. Qualitative data were analysed by means of χ2 test or Fisher’s exact test (if expected frequencies were lower than 5). The Kaplan-Meier method was used to estimate the cumulative probabilities according to surgical procedure and the log rank test to compare the resulting curves. Cox regression analysis was performed to evaluate the effect of prognostic factors on the probability of developing the above events. Results: there were 50 patients in each group. Tumour downstaging and downsizing rates after neoadjuvant chemoradiotherapy were 51 and 26% respectively, and were similar in both groups. All patients had R0 resection with tumour-free resection margins. At long-term follow-up, local recurrence had developed in four patients (8%) after ELRR and three (6%) after TME. Distant metastases occurred in two patients (4%) in each group. There was no statistically significant difference in disease-free survival (P = 0,686). Conclusion: in selected patients, ELRR had similar oncological results to TME.