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Randomized Controlled Trial Multicenter Study
Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial.
- Jérémie Jacques, Marion Schaefer, Timothée Wallenhorst, Thomas Rösch, Vincent Lépilliez, Stanislas Chaussade, Jérôme Rivory, Romain Legros, Jean-Baptiste Chevaux, Sarah Leblanc, Florian Rostain, Maximilien Barret, Jérémie Albouys, Arthur Belle, Anaïs Labrunie, Pierre-Marie Preux, Hugo Lepetit, Martin Dahan, Thierry Ponchon, Sabrina Crépin, Loïc Marais, Julien Magne, and Mathieu Pioche.
- Hépato-Gastro-Entérologie, CHU de Limoges, Limoges, France (J.J., R.L., J.A., H.L., M.D.).
- Ann. Intern. Med. 2024 Jan 1; 177 (1): 293829-38.
BackgroundEndoscopic resection of adenomas prevents colorectal cancer, but the optimal technique for larger lesions is controversial. Piecemeal endoscopic mucosal resection (EMR) has a low adverse event (AE) rate but a variable recurrence rate necessitating early follow-up. Endoscopic submucosal dissection (ESD) can reduce recurrence but may increase AEs.ObjectiveTo compare ESD and EMR for large colonic adenomas.DesignParticipant-masked, parallel-group, superiority, randomized controlled trial. (ClinicalTrials.gov: NCT03962868).SettingMulticenter study involving 6 French referral centers from November 2019 to February 2021.ParticipantsPatients with large (≥25 mm) benign colonic lesions referred for resection.InterventionThe patients were randomly assigned by computer 1:1 (stratification by lesion location and center) to ESD or EMR.MeasurementsThe primary end point was 6-month local recurrence (neoplastic tissue on endoscopic assessment and scar biopsy). The secondary end points were technical failure, en bloc R0 resection, and cumulative AEs.ResultsIn total, 360 patients were randomly assigned to ESD (n = 178) or EMR (n = 182). In the primary analysis set (n = 318 lesions in 318 patients), recurrence occurred after 1 of 161 ESDs (0.6%) and 8 of 157 EMRs (5.1%) (relative risk, 0.12 [95% CI, 0.01 to 0.96]). No recurrence occurred in R0-resected cases (90%) after ESD. The AEs occurred more often after ESD than EMR (35.6% vs. 24.5%, respectively; relative risk, 1.4 [CI, 1.0 to 2.0]).LimitationProcedures were performed under general anesthesia during hospitalization in accordance with the French health system.ConclusionCompared with EMR, ESD reduces the 6-month recurrence rate, obviating the need for systematic early follow-up colonoscopy at the cost of more AEs.Primary Funding SourceFrench Ministry of Health.
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