A multicenter randomized trial conducted in Spain has found that endoscopic submucosal dissection (ESD) is noninferior to transanal minimally invasive surgery (TAMIS) for the treatment of early rectal neoplasms, with comparable safety, shorter hospital stays, and substantially lower costs.
The DSETAMIS-2018 trial enrolled 73 patients with nonpedunculated early rectal neoplasms larger than 20 mm and stagedT1N0 or less. Participants were randomized to undergo either ESD (n=39) or TAMIS (n=34). The primary endpoint was 12-month local recurrence, while secondary outcomes evaluated technical success, complete (R0) and curative resection rates, procedure time, hospital stay, complications, and total cost.
At 12 months, local recurrence occurred in two patients treated with TAMIS and none treated with ESD. The absolute difference in recurrence risk was −6.7% which met the predefined noninferiority margin of 10%. Median hospital stay was one day for ESD versus two days for TAMIS, and mean procedure times were 140 minutes and 110 minutes, respectively. Both approaches demonstrated high technical success (100% for ESD vs 89% for TAMIS) and favorable safety profiles, with similar rates of early complications.
Late complications occurred in 29.6% of TAMIS cases compared with 16.3% of ESD cases, and readmission rates for late complications were higher in the TAMIS group (50%) than in the ESD group (14%). When margins were analyzed using expanded R0 criteria—accepting any tumor-free margin rather than over 1 mm—ESD achieved a complete resection rate of 93% compared with 67% for TAMIS. No cancer-related deaths were reported during a median follow-up of 15 months.
A cost analysis showed that TAMIS procedures were 83% to 103% more expensive than ESD, with median total costs of $13,135 vs $7,175, respectively.
The findings should be interpreted with caution given the small sample size and wide noninferiority margin, noted the authors led by Diego de Frutos Rosa, MD, (Hospital Universitario Puerta de Hierro in Madrid).
Still, the investigators wrote, “ESD was associated with fewer technical constraints, higher procedural success, shorter hospitalization, lower cost, and greater patient acceptance." They emphasized that while both ESD and TAMIS remain valid options, the results support the growing role of ESD in rectal lesion management within minimally invasive oncology.
Funding and author disclosures can be found in the published journal article.
Source: Gastroenterology
