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An international multicentre randomised controlled trial of en bloc resection of bladder tumour vs conventional transurethral resection of bladder tumour: first results of the en bloc resection of urothelium carcinoma of the bladder (EBRUC) II trial

JP. Struck, N. Moharam, A. Leitenberger, J. Weber, L. Lusuardi, D. Oswald, JJ. Rassweiler, M. Fiedler, J. Horňák, M. Babjuk, S. Micali, C. Zaraca, T. Spreu, F. Friedersdorff, H. Borgmann, AS. Merseburger, MW. Kramer

. 2025 ; 135 (3) : 446-455. [pub] 20241027

Language English Country England, Great Britain

Document type Journal Article, Randomized Controlled Trial, Multicenter Study, Comparative Study

Persistent link   https://www.medvik.cz/link/bmc25009756

OBJECTIVES: To determine the safety and oncological advantages of en bloc resection of bladder tumour (ERBT) vs conventional transurethral resection of bladder tumour (cTURBT) in terms of resection quality, staging quality, and safety. PATIENTS AND METHODS: We conducted a single-blinded randomised controlled trial at seven European hospitals with the following inclusion criteria: first diagnosis of non-muscle-invasive bladder cancer, no singular carcinoma in situ, and tumour size >4.3 mm. Patients were randomised intraoperatively in a 1:1 ratio to either the ERBT or cTURBT group. Outcome analysis was performed using the chi-square test, t-test, and multivariate regression analysis. RESULTS: A total of 97 patients were randomised into the study (cTURBT = 40, ERBT = 57). A switch to cTURBT was necessary in two patients (3.5%) and 11.5% of the screened patients were preoperatively excluded for ERBT. There was no difference in the specimen presence of detrusor muscle with 73.7% in cTURBT and 67.3% in ERBT specimens (P = 0.69). There were no significant differences in mean operative time (ERBT 27.6 vs cTURBT 25.4 min, P = 0.450) or mean resection time (ERBT 16.3 vs cTURBT 15.5 min, P = 0.732). Overall the complication rate did not differ significantly (ERBT 18.2% vs cTURBT 7.5%, P = 0.142). Bladder perforations occurred significantly more often in the ERBT group (ERBT seven vs cTURBT none, P = 0.020). R0 status was reported more often after ERBT, whilst a second resection was significantly less frequent after ERBT (P = 0.018). Recurrence rates were comparable for both techniques after 6 months of follow-up. CONCLUSION: The feasibility of ERBT is higher than previously reported. Whereas other perioperative and safety parameters are comparable to cTURBT, bladder perforations occurred significantly more often in the ERBT group and raised safety concerns. This is why this trial was terminated.

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$a Struck, Julian Peter $u Department of Urology, University Hospital Schleswig-Holstein, Lübeck, Germany $u Department of Urology, Brandenburg Medical School Theodor Fontane (MHB), Brandenburg an der Havel, Germany
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$a An international multicentre randomised controlled trial of en bloc resection of bladder tumour vs conventional transurethral resection of bladder tumour: first results of the en bloc resection of urothelium carcinoma of the bladder (EBRUC) II trial / $c JP. Struck, N. Moharam, A. Leitenberger, J. Weber, L. Lusuardi, D. Oswald, JJ. Rassweiler, M. Fiedler, J. Horňák, M. Babjuk, S. Micali, C. Zaraca, T. Spreu, F. Friedersdorff, H. Borgmann, AS. Merseburger, MW. Kramer
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$a OBJECTIVES: To determine the safety and oncological advantages of en bloc resection of bladder tumour (ERBT) vs conventional transurethral resection of bladder tumour (cTURBT) in terms of resection quality, staging quality, and safety. PATIENTS AND METHODS: We conducted a single-blinded randomised controlled trial at seven European hospitals with the following inclusion criteria: first diagnosis of non-muscle-invasive bladder cancer, no singular carcinoma in situ, and tumour size >4.3 mm. Patients were randomised intraoperatively in a 1:1 ratio to either the ERBT or cTURBT group. Outcome analysis was performed using the chi-square test, t-test, and multivariate regression analysis. RESULTS: A total of 97 patients were randomised into the study (cTURBT = 40, ERBT = 57). A switch to cTURBT was necessary in two patients (3.5%) and 11.5% of the screened patients were preoperatively excluded for ERBT. There was no difference in the specimen presence of detrusor muscle with 73.7% in cTURBT and 67.3% in ERBT specimens (P = 0.69). There were no significant differences in mean operative time (ERBT 27.6 vs cTURBT 25.4 min, P = 0.450) or mean resection time (ERBT 16.3 vs cTURBT 15.5 min, P = 0.732). Overall the complication rate did not differ significantly (ERBT 18.2% vs cTURBT 7.5%, P = 0.142). Bladder perforations occurred significantly more often in the ERBT group (ERBT seven vs cTURBT none, P = 0.020). R0 status was reported more often after ERBT, whilst a second resection was significantly less frequent after ERBT (P = 0.018). Recurrence rates were comparable for both techniques after 6 months of follow-up. CONCLUSION: The feasibility of ERBT is higher than previously reported. Whereas other perioperative and safety parameters are comparable to cTURBT, bladder perforations occurred significantly more often in the ERBT group and raised safety concerns. This is why this trial was terminated.
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$a Moharam, Nadim $u Department of Urology, University Hospital Schleswig-Holstein, Lübeck, Germany $u Department of Urology and Urologic Surgery, University Medical Centre Mannheim, Mannheim, Germany $1 https://orcid.org/0000000154640626
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$a Leitenberger, Armin $u Department of Urology, Wolfsburg Hospital, Wolfsburg, Germany
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$a Weber, Jörg $u Department of Urology, Wolfsburg Hospital, Wolfsburg, Germany
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$a Babjuk, Marek $u Department of Urology of the 2nd Faculty of Medicine, Charles University, Prague, Czech Republic $u Motol University Hospital, Prague, Czech Republic
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$a Spreu, Thomas $u Department of Urology, Protest and Hospital Königin Elisabeth Herzberge, Berlin, Germany
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$a Friedersdorff, Frank $u Department of Urology, Protest and Hospital Königin Elisabeth Herzberge, Berlin, Germany
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