Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study - 20/04/24
, Roberta Maselli, PhD 2, Elodie Cesbron-Metivier, MD 3, Stephan Hollerbach, MD 4, Lucio Petruzziello, MD 5, Frédéric Prat, MD 6, Harshit S. Khara, MD 7, Mathieu Pioche, MD, PhD 8, Dirk Hartmann, MD 9, Paola Cesaro, MD 10, Federico Barbaro, MD, PhD 5, Arthur Berger, MD, PhD 11, Cristiano Spada, MD, PhD 10, 5, David L. Diehl, MD 7, Andrea May, MD 12, Thierry Ponchon, MD 8, Alessandro Repici, MD 2, Guido Costamagna, MD 5Abstract |
Background and Aims |
Endoscopic resection is standard treatment for adenomatous colorectal lesions. Depending on lesion morphology and resection technique, recurrence can occur. Scarred adenomas are challenging to resect and may require surgical management. This study evaluated the safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions.
Methods |
This single-arm, prospective, multicenter study was conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary end points were technical success (the ability of the device to resect the lesion[s] without use of other resection devices without device-related serious adverse events [AEs]) and safety (the occurrence of AEs through 90 days). Secondary end points included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens.
Results |
Sixty-five patients were in the intention-to-treat/safety analysis population. Primary analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP patients were solely treated by using the EPR device. Technical success was achieved in 44 (98%) patients. Three (5%) serious AEs occurred: 2 delayed self-limited bleeds and 1 perforation. Nonserious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathologic diagnosis of tissue specimens were achieved in all patients. Twenty-one (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis.
Conclusions |
EPR is safe and effective for benign, persistent, large (>20 mm), scarred colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. A persistence rate of 46.7% indicates that >1 treatment is necessary for effective endoscopic treatment. (Clinical trial registration number: NCT04203667.)
Le texte complet de cet article est disponible en PDF.Abbreviations : AE, EPR, ESD, FTRD, ITT, PP, SAE
Plan
Vol 99 - N° 5
P. 778-786 - mai 2024 Retour au numéro
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