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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

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 con...

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Main Authors: Struck, Julian (Author) , Moharam, Nadim (Author) , Leitenberger, Armin (Author) , Weber, Jörg (Author) , Lusuardi, Lukas (Author) , Oswald, David (Author) , Rassweiler, Jens J. (Author) , Fiedler, Marcel (Author) , Horňák, Jakub (Author) , Babjuk, Marek (Author) , Micali, Salvatore (Author) , Zaraca, Carlo (Author) , Spreu, Thomas (Author) , Friedersdorff, Frank (Author) , Borgmann, Hendrik (Author) , Merseburger, Axel S. (Author) , Kramer, Mario W. (Author)
Format: Article (Journal)
Language:English
Published: March 2025
In: BJU international
Year: 2025, Volume: 135, Issue: 3, Pages: 446-455
ISSN:1464-410X
DOI:10.1111/bju.16543
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1111/bju.16543
Verlag, kostenfrei, Volltext: http://bjui.journals.onlinelibrary.wiley.com/doi/10.1111/bju.16543
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Author Notes:Julian Peter Struck, Nadim Moharam, Armin Leitenberger, Jörg Weber, Lukas Lusuardi, David Oswald, Jens J. Rassweiler, Marcel Fiedler, Jakub Horňák, Marek Babjuk, Salvatore Micali, Carlo Zaraca, Thomas Spreu, Frank Friedersdorff, Hendrik Borgmann, Axel S. Merseburger and Mario W. Kramer
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Summary: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.
Item Description:Erstmals veröffentlicht: 27. Oktober 2024
Gesehen am 15.05.2025
Physical Description:Online Resource
ISSN:1464-410X
DOI:10.1111/bju.16543

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