Randomized clinical trial of endoluminal locoregional resection versus laparoscopic total mesorectal excision for T2 rectal cancer after neoadjuvant therapy

Abstract

Background: In selected patients with early low rectal cancer, locoregional excision combined with neoadjuvant therapy may be an alternative treatment option to total mesorectal excision (TME). Methods: This prospective randomized trial compared endoluminal locoregional resection (ELRR) by transanal endoscopic microsurgery versus laparoscopic TME in the treatment of patients with small non-advanced low rectal cancer. Patients with rectal cancer staged clinically as cT2 N0 M0, histological grade G1–2, with a tumour less than 3 cm in diameter, within 6 cm of the anal verge, were randomized to ELRR or TME. All patients underwent long-course neoadjuvant chemoradiotherapy. Results: Fifty patients in each group were analysed. Overall tumour downstaging and downsizing rates after neoadjuvant chemoradiotherapy were 51 and 26 per cent 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 per cent) after ELRR and three (6 per cent) after TME. Distant metastases were observed in two patients (4 per cent) 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. Unique Protocol ID: URBINO-LEZ-1995; registration number: NCT01609504 (http://www.clinicaltrials.gov).