Multicenter, randomized non-inferiority trial comparing TRansanal minimal InvAsive Surgery (TAMIS) and endoscopic Submucosal dIsseCtion (ESD) for resection of non-pedunculated rectal lesions

Aims Transanal Minimally Invasive Surgery (TAMIS) and Endoscopic Submucosal Dissection (ESD) are minimally invasive techniques for en bloc resection of large non-pedunculated rectal lesions. While TAMIS is widely used in the Netherlands, ESD uptake has been slower. The absence of randomized trials leaves the choice of technique dependent on local expertise. This study aimed to compare TAMIS and ESD regarding effectiveness, safety, patient burden, and costs.

Methods This multicenter randomized non-inferiority trial (NTR7281) included 198 patients with non-pedunculated rectal lesions>2 cm, located≤15 cm from the anal verge. Patients were randomized 1:1 to TAMIS or ESD after an expert panel judged lesions suitable for inclusion. Exclusion criteria included deep-submucosal invasion on endoscopy or imaging, with endoscopy prioritized in discordant cases, prior endoscopic resection, and an unfavorable risk-benefit ratio for local treatment (e.g., poor general condition or very short life expectancy). Randomization was stratified by polyp size (20–40 mm or>40 mm) and distance from the dentate line (< 10 mm, 10–99 mm, 100–150 mm). The primary endpoint was cumulative local recurrence at 12 months (non-inferiority margin: 6%). Secondary endpoints included radical (R0) resection rate, complications (AGREE classification), patient burden (COREFO, EQ-5D-5L, QLQ-CR29), and cost-effectiveness. Intention-to-treat analysis was performed.

Results Of 198 patients randomized (98 TAMIS, 100 ESD), 6 crossed over between groups, and 1 dropped out before treatment. Mean procedure time was 108 minutes for ESD and 80 minutes for TAMIS. En bloc resection rates were 95% for ESD and 92% for TAMIS. In total, 156 benign and 41 malignant lesions (27 T1, 13 T2 and 1 T3) were resected. R0 resection rates were 83% for ESD and 70% for TAMIS (P=0.04). At 12 months, recurrences occurred: 0 (0%) in the ESD group and 4 (4.3%) in the TAMIS group, all benign, with a 4.3% difference favoring ESD (95% CI: -8.4, -0.2), confirming non-inferiority. Overall complication rates were similar (22.0% ESD vs. 20.4% TAMIS; p=0.33). Colorectal functional outcomes showed no significant difference in overall scores, though incontinence was significantly more common in TAMIS patients up to 6 months, resolving by 12 months. Cost-effectiveness analysis is ongoing.

Conclusions This trial is the first to show ESD is non-inferior to TAMIS for local recurrence at 12 months in en bloc resection of large non-pedunculated rectal lesions. Both techniques had similar safety profiles and colorectal functional outcomes. Cost-effectiveness analysis may help determine the preferred technique.

 

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Conflicts of Interest

Authors do not have any conflict of interest to disclose.

Publication History

Article published online:
27 March 2025