Aims Primary: To compare TAMIS and ESD in the treatment of early rectal neoplasia (ERN)
based on the local recurrence rate at 12 months.
Secondary: To compare other efficacy-related aspects: Technical success, en-bloc resection,
R0 resection, procedure time, hospital stay and early local recurrence (< 6 months).
Additionally, to compare complication rates and severity.
Methods Non-inferiority, independent (FSEED Grant 2017), multicenter randomized clinical
trial conducted across three Spanish centers from April 2019 to November 2024. Inclusion
criteria: patients>18 years with non-pedunculated ERN>20 mm, located between 3-14
cm from the anal verge, without suspicion of invasive adenocarcinoma. Exclusion criteria:
LST-GH lesions. Pure randomization to treatment with ESD (experimental group) or TAMIS
(control group). Non-inferiority margin 10%, 80% power, alpha error 0.05, estimated
dropout rate 10%. Calculated 34 patients per arm. ITT and PP analysis. Registered
in ClinicalTrials.govID: NCT03959839.
Results A total of 182 ERNs identified. Inclusion and exclusion criteria met by 96. Refusal
to participate by 23 patients (19 underwent ESD, 4 TAMIS). Randomization involved
73 patients: ESD 39, TAMIS 34. ITT analysis included 37 in the ESD arm and 33 in the
TAMIS arm. Six patients randomized to TAMIS ultimately underwent ESD; PP analysis
included 43 ESD and 27 TAMIS patients.
Primary Outcome: ARR for local recurrence at 12 months ITT: -6.9 (90% CI -14.6 – 0.8);
PP: -8.7 (90% CI -18.4 – 1.0).
Secondary Outcomes: Technical success ITT 90.9 vs. 100 p=0.1, PP 88.9 vs. 100 p=0.05;
En-bloc ITT 97.0 vs. 97.3 p=0.7, PP 96.3 vs. 97.7 p=0.6; R0 resection ITT 72.7 vs.
91.9 p=0.05, PP 66.7 vs. 93.0 p<0.01; Procedure time (minutes), median (IQR) ITT 60
(55) vs. 105 (56) p<0.01, PP 50 (18) vs. 105 (58) p<0.01; Hospital stay (days), median
(IQR) ITT 2 (2) vs. 1 (0) p=0.04, PP 2 (2) vs. 1 (0) p<0.01; Early recurrence (ARR)
ITT -6.5 (-15.1 – 2.1), PP -8.0 (-18.6 – 2.6).
Complications: Early (< 24 hours): ESD had 2 perforations and 5 cases of bleeding,
with no clinical impact. TAMIS had 1 case of bleeding and fever (significant increase
in hospital stay). Late (> 24 hours): ESD had 4 PECS, 3 cases of bleeding, and fever,
without clinical impact or prolonged hospital stay. TAMIS had 6 cases of bleeding
(2 requiring urgent endoscopy), hypertension, and fever, with no significant effect
on hospital stay.
Conclusions ESD is not inferior to TAMIS in treating ERN. Additionally, ESD is perceived by patients
as less invasive, presents fewer technical limitations, and achieves superior R0 resection
rates.
Although TAMIS is faster, it involves a longer hospital stay
Both techniques show a favorable safety profile.
