Loco-regional endoluminal resection with TEM technique versus Total Mesorectal Excision by laparoscopic in the treatment of rectal cancer T2 after neoadjuvant therapy

Aim: Locoregional resection after neoadjuvant therapy may be an alternative treatment option to total mesorectal excision (TME) in selected patients with non-advanced low rectal cancer. Methods: In a prospective randomized trial Endoluminal locoregional resection (ELRR) by transanal endoscopic microsurgery (TEM) was compared to laparoscopic TME for the treatment of patients with early low rectal cancer. Inclusion criteria were: patients with cT2 N0 M0, G1–2, rectal cancer, tumour diameter less than 3 cm, located within 6 cm from the anal verge. Higher-risk patients (ASA III–IV) with more proximally located tumours, poorly differentiated (G3) or undifferentiated (G4) tumours, and tumours with lymphovascular or perineural invasion, were excluded.All patients underwent long-course three-dimensional four-field chemoradiotherapy in the prone position, with bladder preparation and use of intravenous contrast (14). The total dose given was 50·4 Gy in 28 fractions over 5 weeks. The irradiated areas were: anus, rectum, mesorectum, and regional and iliac lymph nodes. The superior limit was L5–S1 and the inferior limit around 3–5 cm under the ischiopubic ramus. A continuous infusion of 5-fluorouracil 200 mg per m2 per day was administered during radiotherapy treatment.Results: The trial included fifty patients in each group. Tumour downstaging and downsizing rates after neoadjuvant chemoradiotherapy were 51 and 26 per cent, respectively, and were similar in both groups. R0 resection with tumour-free resection margins was achieved in all patients. Local recurrence developed in four patients (8 per cent) after ELRR and in three (6 per cent) after TME at long-term follow-up. Distant metastases occurred in two patients (4 per cent) in each group. No statistically significant difference in disease-free survival was observed(P = 0·686). Discussion and Conclusions: In selected patients with non-advanced low rectal cancer after neoadjuvant long-course radiochemotherapy, the oncological results of ELRR by TEM and of TME were similar. The technical accuracy of ELRR, which can be achieved only by TEM carried out by well trained surgeons, provides a curative treatment that avoids the risks of major surgery, with more favourable short-term results and similar long-term oncological outcomes to those of TME.