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Conventional white light imaging-assisted transurethral resection of bladder tumour (TURBT) versus IMAGE1S-assisted TURBT in non-muscle-invasive bladder cancer patients: trial protocol and 18 months results

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Abstract

Purpose

White light (WL) is the traditional imaging modality for transurethral resection of bladder tumour (TURBT). IMAGE1S is a likely addition. We compare 18-mo recurrence rates following TURBT using IMAGE1S versus WL guidance.

Methods

Twelve international centers conducted a single-blinded randomized controlled trial. Patients with primary and recurrent non-muscle-invasive bladder cancer (NMIBC) were randomly assigned 1:1 to TURBT guided by IMAGE1S or WL. Eighteen-month recurrence rates and subanalysis for primary/recurrent and risk groups were planned and compared by chi-square tests and survival analyses.

Results

689 patients were randomized for WL-assisted (n = 354) or IMAGE1S-assisted (n = 335) TURBT. Of these, 64.7% had a primary tumor, 35.3% a recurrent tumor, and 4.8%, 69.2% and 26.0% a low-, intermediate-, and high-risk tumor, respectively. Overall, 60 and 65 patients, respectively, completed 18-mo follow-up, with recurrence rates of 31.0% and 25.4%, respectively (p = 0.199). In patients with primary, low-/intermediate-risk tumors, recurrence rates at 18-mo were significantly higher in the WL group compared with the IMAGE1S group (31.9% and 22.3%, respectively: p 0.035). Frequency and severity of adverse events were comparable in both treatment groups. Immediate and adjuvant intravesical instillation therapy did not differ between the groups. Potential limitations included lack of uniformity of surgical resection, central pathology review, and missing data.

Conclusion

There was not difference in the overall recurrence rates between IMAGE1S and WL assistance 18-mo after TURBT in patients with NMIBC. However, IMAGE1S-assisted TURBT considerably reduced the likelihood of disease recurrence in primary, low/intermediate risk patients.

Registration

ClinicalTrials.gov Identifier NCT02252549 (30-09-2014).

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Acknowledgements

The authors acknowledge AUA Data Management and Statistical Analysis providing statistical support for the analyses reported in this manuscript. The work of Dr. Estefania Linares-Espinós and Dr. Carlos R. Trelles Guzmán was supported by grants from Madrid Regional Government ‘Immunothercan’ [B2017/BMD-3733-2]

Funding

The study was funded by the Karl Storz company through an unrestricted educational grant to the CROES.

Author information

Authors and Affiliations

  1. Department of Urology, Istanbul Medipol Mega University Hospital, Istanbul, Turkey

    Jean de la Rosette, Mustafa Yucel Boz & Pilar Laguna

  2. Department of Urology, Pletnew Moscow City Hospital, Moscow, Russia

    Alexey Martov

  3. Department of Urology, IRCCS Humanitas Research Hospital, Milan, Italy

    Rodolfo Hurle

  4. Department of Urology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

    Gabriel Favre

  5. Department of Urology, University General Hospital of Heraklion, University of Crete, Medical School, Heraklion, Crete, Greece

    Charalampos Mamoulakis

  6. Department of Urology, Centro Hospitalar Universitário Do Porto, Hospital de Santo António, Porto, Portugal

    Manuel Castanheira de Oliveira

  7. Department of Urology, University of Tuebingen Medical Center, Tuebingen, Germany

    Arnulf Stenzl

  8. Department of Urology, La Paz University Hospital, Madrid, Spain

    Estefania Linares-Espinós & Carlos R. Trelles Guzmán

  9. Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece

    Stavros Gravas

  10. Medical School, University of Cyprus, Nicosia, Cyprus

    Stavros Gravas

  11. Department of Urology, Klinikum Sindelfingen-Boblingen, Germany

    Thomas Knoll

  12. Department of Urology, Spital Thurgau, AG, Switzerland

    Thomas Herrmann

  13. Department of Urology, Hannover Medical School (MHH), Hannover, Germany

    Thomas Herrmann

Authors
  1. Jean de la Rosette
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  2. Alexey Martov
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  3. Rodolfo Hurle
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  4. Gabriel Favre
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  6. Manuel Castanheira de Oliveira
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  7. Arnulf Stenzl
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  8. Estefania Linares-Espinós
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  9. Carlos R. Trelles Guzmán
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  12. Mustafa Yucel Boz
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  13. Thomas Herrmann
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  14. Pilar Laguna
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Contributions

JR: Protocol/project development, data collection or management, data analysis, manuscript writing/editing. AM: Protocol/project development, data collection or management. RH: Data collection or management. GF: Data collection or management. CM: Protocol/project development, data collection or management. MCO: Protocol/project development, data collection or management. AS: Protocol/project development, data collection or management, Manuscript writing/editing. ELE: Data collection or management. CRTG: Data collection or management. SG: Protocol/project development, data collection or management. TK: Protocol/project development, data collection or management. MYB: Data collection or management. TH: Protocol/project development, data collection or management. PL: Protocol/project development, data collection or management, manuscript writing/editing.

Corresponding author

Correspondence to Jean de la Rosette.

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Conflict of interest

Jean de la Rosette: none, Pilar Laguna: none, Thomas Herrmann: Company Consultant, Honoraria, Stipendium, Research Collaboration and Grant—Karl Storz; Advisory board, honoraria—Boston Scientific; Advisory, Research Collaboration, Honoraria—Lisa Laser GmbH, Alexey Martov: none, Charalampos Mamoulakis: none, Thomas Knoll: Speaker/Advisor Karl Storz Endoscopes—Manuel Castanheira de Oliveira: none, Mustafa Yucel Boz: none, Stavros Gravas: none, Linares-Espinós: none, Trelles Guzmán: none, Arnulf Stenzl: Ad Board/Consultant, Ipsen Pharma, Roche; Ad Board/Consultant, Janssen; Ad Board/Synergo; Ad Board/Ferring; Ad Board/Astellas; Ad Board/AstraZeneca; Institution Research grant, Amgen Inc; Institution Research grant, Ipsen Pharma; Institution Research grant, Karl Storz AG.

Research involving human participants and/or animals

The trial was registered at ClinicalTrials.gov (Identifier NCT02252549). The trial was approved by the ethics committee of the Amsterdam UMC (NL50451.018.14), University of Amsterdam, Amsterdam, the Netherlands.

Informed consent

The trial was performed in accordance to the Declaration of Helsinki. Patients were included after information and signing of the informed consent form.

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de la Rosette, J., Martov, A., Hurle, R. et al. Conventional white light imaging-assisted transurethral resection of bladder tumour (TURBT) versus IMAGE1S-assisted TURBT in non-muscle-invasive bladder cancer patients: trial protocol and 18 months results. World J Urol 40, 727–738 (2022). https://doi.org/10.1007/s00345-021-03866-4

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  • DOI: https://doi.org/10.1007/s00345-021-03866-4

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