ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) VERSUS TRANSANAL MINIMALLY INVASIVE SURGERY (TAMIS) FOR EARLY RECTAL NEOPLASMS: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
Simon S. Ng*, Sophie S. Hon, Tony Mak, Kaori Futaba, Dennis Ngo, Simon Chu, Man Fung Ho, Wing Wa Leung, Yee Ni C. Wong, Janet F. Lee
Surgery, The Chinese University of Hong Kong, Hong Kong , Hong Kong
Background and Objectives: Transanal minimally invasive surgery (TAMIS) is an effective surgical treatment for early rectal neoplasms not amenable to en bloc resection by conventional colonoscopic techniques. Endoscopic submucosal dissection (ESD) is a revolutionary endoscopic procedure that enables en bloc resection of large rectal neoplasms with low morbidity. This prospective, randomized, controlled superiority trial aimed to compare the short-term clinical outcomes, functional outcomes, quality of life, and costs between ESD and TAMIS for early rectal neoplasms.
Methods: Patients diagnosed with early rectal neoplasms (those without endoscopic signs of massive submucosal invasion or unfavorable histology on biopsy) '‰¥2 cm in size that were not amenable to en bloc resection by conventional colonoscopic techniques were randomly assigned (1:1) to receive either ESD or TAMIS performed by the same group of experienced colorectal surgeons. The primary outcome was 30-day morbidity/mortality. Secondary outcomes were en bloc resection rate, R0 resection rate, hospital stay, functional outcomes and quality of life, and costs. Planned enrollment was 114, but the trial was halted prematurely due to slow accrual as well as safety/efficacy data demonstrated by an unplanned interim analysis.
Results: From June 2017 to June 2019, 95 patients were screened for participation, and 53 eligible patients were randomly assigned to ESD (n = 27) or TAMIS (n = 26). The demographic data and tumor characteristics of the two groups were comparable. Two patients (7.4%) in the ESD group and 8 patients (30.8%) in the TAMIS group developed 30-day morbidity (P = 0.039, Fisher's exact test). One patient in the ESD group developed rectal bleeding on postoperative day 1 and required endoscopic clipping for hemostasis. No patients in the TAMIS group required reintervention for morbidity. All patients could achieve an en bloc resection, and R0 resection rate was similar between the ESD and TAMIS groups (88.9% vs. 92.3%; P = 1.000, Fisher's exact test). Length of hospital stay was significantly shorter in the ESD group when compared with the TAMIS group (1.9 '± 1.5 days vs. 3.2 '± 2.9 days; P = 0.042, Student's t test). The total direct cost was also lower in the ESD group than in the TAMIS group (US$10,273 '± 1,996 vs. US$12,793 '± 4,028; P = 0.005, Student's t test). Functional outcomes and quality of life did not differ between the two groups.
Conclusions: This trial was prematurely stopped because of slow accrual and a significantly lower 30-day morbidity rate demonstrated in the ESD group. The ESD group was also associated with shorter hospital stay and lower direct cost. However, given the premature termination of the trial, the results should be interpreted with caution. (ClinicalTrials.gov number, NCT03217773)
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