Transanal Endoscopic Microsurgery or Endoscopic Submucosal Dissection in Early Rectal Tumors: A Clinical and Cost-Effectiveness Analysis: The MUCEM Study.

Abstract

For the local excision of early rectal tumors (ERTs), the relative effectiveness of endoscopic submucosal dissection (ESD) vs transanal endoscopic microsurgery (TEM) is subject to debate. The comparisons are limited to retrospective, single-center studies lacking a health economic assessment. A cost-effectiveness analysis was conducted alongside a nonrandomized, 2-arm, comparative, multicenter study. The main inclusion criterion was an ERT (adenomas, in situ and usT1N0 carcinomas) that could be resected with ESD or TEM, depending on the center. The primary effectiveness criterion was complete resection. A health care system perspective and a 1-year horizon were adopted for the cost evaluation. The results of the analysis were adjusted for baseline covariates: age, sex, body mass index, American Society of Anesthesiologists score, histology, and previous pelvic surgery. A total of 213 ESD and 117 TEM procedures were analyzed. At 1 year and with a willingness to pay of €2500 for complete resection, the incremental net monetary benefit of ESD was significant (€1797; 95% confidence interval, €861-€3,032; P < .001). ESD was more cost-effective for decision thresholds ranging from €0 to €6000. In terms of secondary outcomes, the en bloc excision rate favored ESD (99.0% vs 92.5%, P < .01). There were no significant between-group differences in overall and major morbidity. At 3 years, a cost-utility analysis did not reveal between-group differences in health-related quality of life, and the overall survival rates were similar. However, the disease-free survival rate was higher after ESD (94.3% vs 84.6% for TEM; adjusted hazard ratio, 3.55; 95% confidence interval, 1.64-7.75; P < .001). For ERT, ESD was more cost-effective and offered higher-quality excision and lower recurrence rates than TEM. (ClinicalTrials.gov, Number: NCT02885142).