You have accessJournal of UrologyCME1 May 2022PD26-01 EN-BLOC VERSUS CONVENTIONAL TRANSURETHRAL RESECTION OF BLADDER TUMORS: SINGLE-CENTER PROSPECTIVE RANDOMIZED TRIAL Andrea Gallioli, Pietro Diana, Matteo Fontana, Angelo Territo, Alberto Piana, Ferran Algaba, Óscar Rodriguez-Faba, Asier Marcadé, Alejandra Bravo, Antonio Rosales, Josep Maria Gaya, Joan Palou, and Alberto Breda Andrea GallioliAndrea Gallioli More articles by this author , Pietro DianaPietro Diana More articles by this author , Matteo FontanaMatteo Fontana More articles by this author , Angelo TerritoAngelo Territo More articles by this author , Alberto PianaAlberto Piana More articles by this author , Ferran AlgabaFerran Algaba More articles by this author , Óscar Rodriguez-FabaÓscar Rodriguez-Faba More articles by this author , Asier MarcadéAsier Marcadé More articles by this author , Alejandra BravoAlejandra Bravo More articles by this author , Antonio RosalesAntonio Rosales More articles by this author , Josep Maria GayaJosep Maria Gaya More articles by this author , Joan PalouJoan Palou More articles by this author , and Alberto BredaAlberto Breda More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002574.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Transurethral resection of bladder tumor (TURBT) is considered the gold standard in the diagnosis and risk stratification bladder cancer (BC). En-bloc resection of bladder tumor (ERBT) has been proposed to improve resection quality. Recently, the International Collaborative Consensus Statement on ERBT underlined the lack of high-quality prospective studies precluding the achievement of solid conclusion on ERBT. The aim of our study is to compare TURBT and ERBT in pathological diagnosis, surgical, and oncological outcomes. METHODS: This study is a prospective, randomized trial enrolling patients diagnosed with BC and undergoing endoscopic intervention. Inclusion criteria were: tumor size of ≤3 cm, and ≤3 lesions, and no sign of muscle invasion and/or ureteral involvement. The primary outcome is the staging of BC. Secondary outcomes included T1 substaging (microstaging systems T1a/b/c), intraoperative complications, rate of adjuvant treatment, postoperative complications, oncologic outcomes. With an α and β risk of 2.5% and 20% with a non-inferior difference of 5% en the rate of detrusor muscle presence, a total of 300 subjects were included in the study with 1:1.5 treatment allocation for ERBT. The trial (NCT04712201) was approved by the Institutional Review Board (2017/09c). RESULTS: From 03/2018 to 06/2021, 300 patients met inclusion criteria and 248 (82.7%) of these were underwent the assigned intervention. 108 (43.5%) and 140 (56.5%) patients were submitted to TURBT and ERBT. Pre-operatively, the populations were comparable. Table 1 shows the pathological results per patient. The rate of Tx was comparable (2.8% TURBT vs 4.3% ERBT). T1 substaging was feasible in 80% TURBT vs 100% ERBT (p=0.02). The rate of obturator nerve reflex and perforation were comparable (both p=0.2). In patients candidate to adjuvant treatment, the instillation was performed in 86% and 94% in TURBT and ERBT (p=0.1). Clavien-Dindo >2 complications were 2.8% vs 4.3% for TURBT and ERBT. Surgical, irrigation, and catheterization time were all comparable (all p>0.05). Recurrence rate at a median follow-up of 12 months (7-25) was 17.6% vs 12.9% in TURBT and ERBT (p>0.1). CONCLUSIONS: ERBT is non-inferior to TURBT in pathological, surgical, and short term oncological outcomes. ERBT reported a higher rate of T1 substaging feasibility compared to TURBT. This is the largest randomized study in this setting. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e487 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Andrea Gallioli More articles by this author Pietro Diana More articles by this author Matteo Fontana More articles by this author Angelo Territo More articles by this author Alberto Piana More articles by this author Ferran Algaba More articles by this author Óscar Rodriguez-Faba More articles by this author Asier Marcadé More articles by this author Alejandra Bravo More articles by this author Antonio Rosales More articles by this author Josep Maria Gaya More articles by this author Joan Palou More articles by this author Alberto Breda More articles by this author Expand All Advertisement PDF DownloadLoading ...
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