Multicenter, randomized non-inferiority trial comparing TRansanal minimal InvAsive Surgery (TAMIS) and endoscopic Submucosal dIsseCtion (ESD) for resection of non-pedunculated rectal lesions
Endoscopy, vol. 57
Abstract
Aims Transanal Minimally Invasive Surgery (TAMIS) and Endoscopic Submucosal Dissection (ESD) are minimally invasive techniques for en bloc resection of large non-pedunculated rectal lesions. While TAMIS is widely used in the Netherlands, ESD uptake has been slower. The absence of randomized trials leaves the choice of technique dependent on local expertise. This study aimed to compare TAMIS and ESD regarding effectiveness, safety, patient burden, and costs. Methods This multicenter randomized non-inferiority trial (NTR7281) included 198 patients with non-pedunculated rectal lesions>2 cm, located≤15 cm from the anal verge. Patients were randomized 1:1 to TAMIS or ESD after an expert panel judged lesions suitable for inclusion. Exclusion criteria included deep-submucosal invasion on endoscopy or imaging, with endoscopy prioritized in discordant cases, prior endoscopic resection, and an unfavorable risk-benefit ratio for local treatment (e.g., poor general condition or very short life expectancy). Randomization was stratified by polyp size (20–40 mm or>40 mm) and distance from the dentate line (< 10 mm, 10–99 mm, 100–150 mm). The primary endpoint was cumulative local recurrence at 12 months (non-inferiority margin: 6%). Secondary endpoints included radical (R0) resection rate, complications (AGREE classification), patient burden (COREFO, EQ-5D-5L, QLQ-CR29), and cost-effectiveness. Intention-to-treat analysis was performed. Results Of 198 patients randomized (98 TAMIS, 100 ESD), 6 crossed over between groups, and 1 dropped out before treatment. Mean procedure time was 108 minutes for ESD and 80 minutes for TAMIS. En bloc resection rates were 95% for ESD and 92% for TAMIS. In total, 156 benign and 41 malignant lesions (27 T1, 13 T2 and 1 T3) were resected. R0 resection rates were 83% for ESD and 70% for TAMIS (P=0.04). At 12 months, recurrences occurred: 0 (0%) in the ESD group and 4 (4.3%) in the TAMIS group, all benign, with a 4.3% difference favoring ESD (95% CI: -8.4, -0.2), confirming non-inferiority. Overall complication rates were similar (22.0% ESD vs. 20.4% TAMIS; p=0.33). Colorectal functional outcomes showed no significant difference in overall scores, though incontinence was significantly more common in TAMIS patients up to 6 months, resolving by 12 months. Cost-effectiveness analysis is ongoing. Conclusions This trial is the first to show ESD is non-inferior to TAMIS for local recurrence at 12 months in en bloc resection of large non-pedunculated rectal lesions. Both techniques had similar safety profiles and colorectal functional outcomes. Cost-effectiveness analysis may help determine the preferred technique. Publication History Article published online: 27 March 2025 © 2025. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Authors 40
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Nik Dekkers Aachen
Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center (LUMC), Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, Netherlands
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University Medical Center Utrecht
Affiliation as printed
UMC Utrecht, Utrecht, Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Amsterdam UMC, Amsterdam, Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Amsterdam UMC, Amsterdam, Netherlands
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Affiliation as printed
Erasmus University Medical Center, Department of Gastroenterology ' Hepatology, Rotterdam, Netherlands
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University Medical Center Utrecht
Affiliation as printed
UMC Utrecht, Utrecht, Netherlands
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Affiliation as printed
Isala Zwolle, Zwolle, Netherlands
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Affiliation as printed
Albert Schweitzer Hospital, Dordrecht, Netherlands
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Cancer Center Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
VUmc Cancer Center Amsterdam, Amsterdam, Netherlands
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Affiliation as printed
Meander Medical Center, Amersfoort, Netherlands
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A. Stijn L. P. Crobach Aachen
Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center (LUMC), Leiden, Netherlands
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Hao Dang Aachen
Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center (LUMC), Leiden, Netherlands
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University Medical Center Utrecht
Affiliation as printed
UMC Utrecht, Utrecht, Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
The Netherlands Cancer Institute (NKI), Amsterdam, Netherlands
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Affiliation as printed
IJsselland Hospital, Capelle aan den IJssel, Netherlands
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Affiliation as printed
Haga Hospital location Leyweg, Den Haag, Netherlands
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W Van Den Hout Aachen
Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center (LUMC), Leiden, Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
The Netherlands Cancer Institute (NKI), Amsterdam, Netherlands
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Jolein van der Kraan Aachen
Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center (LUMC), Leiden, Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
Department of Gastrointestinal Oncology, Netherlands Cancer Institute (NKI), Amsterdam, Netherlands
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Affiliation as printed
HMC Westeinde, Den Haag, Netherlands
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P.A. Nijenhuis Aachen
Affiliation as printed
Alrijne Hospital Leiden, Leiden, Netherlands
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Affiliation as printed
Gelre ziekenhuizen Apeldoorn, Apeldoorn, Netherlands
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Affiliation as printed
Diakonessenhuis Utrecht, Utrecht, Netherlands
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Affiliation as printed
Franciscus Gasthuis ' Vlietland, Rotterdam, Netherlands
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Mar Rodríguez‐Girondo Aachen
Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center (LUMC), Leiden, Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Bernhoven Hospital, Uden, Netherlands
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Affiliation as printed
Department of Gastroenterology, Meander Medical Center, Amersfoort, Netherlands
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Affiliation as printed
Franciscus Gasthuis, Rotterdam, Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Isala, Zwolle, Netherlands
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Affiliation as printed
Bernhoven, Uden, Netherlands
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Affiliation as printed
HMC Westeinde, Den Haag, Netherlands
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Affiliation as printed
Isala Zwolle, Zwolle, Netherlands
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Rogier Ten Hove Aachen
Affiliation as printed
Alrijne Hospital Leiderdorp, Leiderdorp, Netherlands
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Hans F. A. Vasen Aachen
Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center (LUMC), Leiden, Netherlands
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Affiliation as printed
IJsselland Hospital, Capelle aan den IJssel, Netherlands
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James C.H. Hardwick Aachen
Leiden University Medical Center
Affiliation as printed
Leiden University Medical Center (LUMC), Leiden, Netherlands
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