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A Randomized Trial of Endoscopic Submucosal Dissection vs Transanal Minimally Invasive Surgery in Early Rectal
Diego de Frutos Rosa1, Isabel Alonso Sebastián2, David Barquero Declara3
1Gastroenterology Department (Advanced Endoscopy and High-Risk Unit), Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain; Puerta de Hierro-Segovia de Arana Biomedical Research Institute (IDIPHISA), Majadahonda, Madrid, Spain.
Background & Aims:
The optimal approach for the local resection of early rectal neoplasms (ERNs) remains debated, with limited data comparing transanal minimally invasive surgery (TAMIS) and endoscopic submucosal dissection (ESD).
Methods:
A multicenter, randomized, open-label, noninferiority trial was conducted in 3 Spanish tertiary centers. Patients with nonpedunculated ERNs >20 mm and ≤cT1N0 were randomized to TAMIS or ESD. The primary outcome was 12-month recurrence (noninferiority margin, 10%). Secondary outcomes included technical success, en bloc, R0, and curative resection rates, procedure time, hospital stay, complications, and costs. Analyses followed intention-to-treat and per-protocol (PP) principles.
Results:
Of 185 evaluated patients, 73 were randomized (34 TAMIS, 39 ESD) and 66 (90.4%) completed follow-up. Local recurrence occurred in 2 TAMIS patients and none in ESD. The 12-month recurrence risk difference was -6.7% (90% confidence interval, -14.2 to 0.8) in intention-to-treat and -8.3% (90% confidence interval, -17.6 to 0.9) in PP analysis. ESD demonstrated shorter hospital stays (1 vs 2 days) and higher technical success (100% vs 88.9%; PP). No significant differences were observed in overall complications. Estimated overall costs were €11,289.27 for TAMIS vs €6167.14 for ESD. Of the 112 off-study cases, 108 (96.4%) were successfully treated with ESD.
Conclusions:
ESD appears to be noninferior to TAMIS for local resection of ERNs regarding 12-month recurrence. Both show favorable safety profiles. ESD was associated with fewer technical constraints, higher procedural success, shorter hospitalization, lower cost, and greater patient acceptance. These results should be interpreted considering the wide noninferiority margin, limited sample size, and absence of multiplicity adjustment. (ClinicalTrials.gov, Number: NCT03959839).
Insights
Endoscopic submucosal dissection (ESD) is noninferior to transanal minimally invasive surgery (TAMIS) for early rectal neoplasm resection. ESD offers higher success rates, shorter hospital stays, and lower costs, with similar safety profiles.
Area of Science:
- Gastroenterology
- Surgical Oncology
- Minimally Invasive Surgery
Background:
- The optimal local resection technique for early rectal neoplasms (ERNs) is debated.
- Limited comparative data exists for transanal minimally invasive surgery (TAMIS) and endoscopic submucosal dissection (ESD).
Purpose of the Study:
- To compare the efficacy and safety of TAMIS versus ESD for local resection of ERNs.
- To evaluate 12-month recurrence rates as the primary outcome in a randomized noninferiority trial.
Main Methods:
- A multicenter, randomized, open-label, noninferiority trial involving 73 patients with ERNs (>20 mm, ≤cT1N0).
- Patients were randomized to TAMIS or ESD, with 12-month recurrence as the primary endpoint.
- Secondary outcomes included technical success, resection quality, procedure time, complications, and costs.
Main Results:
- Local recurrence occurred in 2 TAMIS patients and none in the ESD group (noninferiority suggested).
- ESD demonstrated higher technical success (100% vs 88.9%), shorter hospital stays (1 vs 2 days), and lower estimated costs (€6,167 vs €11,289).
- No significant differences in overall complications were observed between TAMIS and ESD.
Conclusions:
- ESD appears noninferior to TAMIS for local resection of ERNs regarding 12-month recurrence.
- ESD offers advantages in technical success, hospitalization duration, cost-effectiveness, and patient acceptance.
- Results should be interpreted cautiously due to the wide noninferiority margin and limited sample size.
