Abstract
Background and AimsEndoscopic 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 safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions. MethodsSingle-arm, prospective, multicenter, study conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary endpoints 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 (SAE)) and safety (the occurrence of adverse events (AE) through 90 days). Secondary endpoints included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens. ResultsSixty-five patients were in the intent-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 the EndoRotor device. Technical success was achieved in 44 (98%) patients. Three (5%) SAEs occurred: 2 delayed self-limited bleeds and 1 perforation. Non-serious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathological diagnosis of tissue specimens were achieved in all patients, 21 (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis. ConclusionsEPR is a safe and effective for benign, persistent, large (>20mm) scarred, colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. Persistence rate of 46.7% show that more than one treatment are necessary for effective endoscopic treatment.
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