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Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)

BACKGROUND: Transurethral resection of bladder tumor (TURBT) is an essential procedure both for the treatment and staging of bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). The dissemination of cancer cells during resection and the consequent seeding into the bladder mucosa...

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Autores principales: Miyake, Makito, Nishimura, Nobutaka, Inoue, Takashi, Suzuki, Shota, Fujii, Tomomi, Owari, Takuya, Hori, Shunta, Nakai, Yasushi, Toritsuka, Michihiro, Nakagawa, Hitoshi, Tsukamoto, Shinji, Anai, Satoshi, Torimoto, Kazumasa, Yoneda, Tatsuo, Tanaka, Nobumichi, Fujimoto, Kiyohide
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7881486/
https://www.ncbi.nlm.nih.gov/pubmed/33579327
http://dx.doi.org/10.1186/s13063-021-05094-y
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author Miyake, Makito
Nishimura, Nobutaka
Inoue, Takashi
Suzuki, Shota
Fujii, Tomomi
Owari, Takuya
Hori, Shunta
Nakai, Yasushi
Toritsuka, Michihiro
Nakagawa, Hitoshi
Tsukamoto, Shinji
Anai, Satoshi
Torimoto, Kazumasa
Yoneda, Tatsuo
Tanaka, Nobumichi
Fujimoto, Kiyohide
author_facet Miyake, Makito
Nishimura, Nobutaka
Inoue, Takashi
Suzuki, Shota
Fujii, Tomomi
Owari, Takuya
Hori, Shunta
Nakai, Yasushi
Toritsuka, Michihiro
Nakagawa, Hitoshi
Tsukamoto, Shinji
Anai, Satoshi
Torimoto, Kazumasa
Yoneda, Tatsuo
Tanaka, Nobumichi
Fujimoto, Kiyohide
author_sort Miyake, Makito
collection PubMed
description BACKGROUND: Transurethral resection of bladder tumor (TURBT) is an essential procedure both for the treatment and staging of bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). The dissemination of cancer cells during resection and the consequent seeding into the bladder mucosa is the main cause of post-TURBT intravesical recurrence. Although the tumor dissemination is inevitable during conventional TURBT (cTURBT), this drawback can be overcome by tumor resection in one piece with intact surrounding normal tissues, referred to as en bloc resection. We previously described the photodynamic diagnosis (PDD)-assisted en bloc TURBT (EBTUR) technique and its favorable outcomes. Based on our preliminary studies, this randomized controlled trial was designed to evaluate the superiority of PDD-EBTUR to PDD-cTURBT. METHODS: The FLEBER study is a single-center randomized controlled trial in NMIBC patients who require TURBT. The longest diameter of the tumor must be between 6 and 30 mm. A total of 160 eligible patients will be enrolled after screening and randomly allocated to the PDD-EBTUR (experimental) and PDD-cTURBT (control) groups in a 1:1 ratio (80 cases to 80 cases). All patients will be treated using a single, immediate postoperative intravesical chemotherapy with epirubicin. The primary endpoint of this trial is the 2-year recurrence-free survival after surgery in pathologically proven low- or intermediate-risk NMIBC. All patients will be monitored by cystoscopy and urine cytology every 3 months for 2 years. Patient data including adverse events and complications, and data from frequency volume charts, pain scales, and health-related QOL questionnaires will be collected before and after the TURBT at indicated visits. DISCUSSION: The goal of this trial is to determine the potential benefits of PDD-cTURBT and PDD-EBTUR followed by a single immediate postoperative intravesical chemotherapy in patients with low- or intermediate-risk NMIBC who undergo TURBT. Ultimately, our findings will lead to the development of better interventions and potentially change the standard of care. TRIAL REGISTRATION: This clinical trial was prospectively registered with the UMIN Clinical Trials Registry on 1 August 2020. The reference number is UMIN000041273, and the Ethics Committee of Nara Medical University Approval ID is 2702. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05094-y.
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spelling pubmed-78814862021-02-17 Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study) Miyake, Makito Nishimura, Nobutaka Inoue, Takashi Suzuki, Shota Fujii, Tomomi Owari, Takuya Hori, Shunta Nakai, Yasushi Toritsuka, Michihiro Nakagawa, Hitoshi Tsukamoto, Shinji Anai, Satoshi Torimoto, Kazumasa Yoneda, Tatsuo Tanaka, Nobumichi Fujimoto, Kiyohide Trials Study Protocol BACKGROUND: Transurethral resection of bladder tumor (TURBT) is an essential procedure both for the treatment and staging of bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). The dissemination of cancer cells during resection and the consequent seeding into the bladder mucosa is the main cause of post-TURBT intravesical recurrence. Although the tumor dissemination is inevitable during conventional TURBT (cTURBT), this drawback can be overcome by tumor resection in one piece with intact surrounding normal tissues, referred to as en bloc resection. We previously described the photodynamic diagnosis (PDD)-assisted en bloc TURBT (EBTUR) technique and its favorable outcomes. Based on our preliminary studies, this randomized controlled trial was designed to evaluate the superiority of PDD-EBTUR to PDD-cTURBT. METHODS: The FLEBER study is a single-center randomized controlled trial in NMIBC patients who require TURBT. The longest diameter of the tumor must be between 6 and 30 mm. A total of 160 eligible patients will be enrolled after screening and randomly allocated to the PDD-EBTUR (experimental) and PDD-cTURBT (control) groups in a 1:1 ratio (80 cases to 80 cases). All patients will be treated using a single, immediate postoperative intravesical chemotherapy with epirubicin. The primary endpoint of this trial is the 2-year recurrence-free survival after surgery in pathologically proven low- or intermediate-risk NMIBC. All patients will be monitored by cystoscopy and urine cytology every 3 months for 2 years. Patient data including adverse events and complications, and data from frequency volume charts, pain scales, and health-related QOL questionnaires will be collected before and after the TURBT at indicated visits. DISCUSSION: The goal of this trial is to determine the potential benefits of PDD-cTURBT and PDD-EBTUR followed by a single immediate postoperative intravesical chemotherapy in patients with low- or intermediate-risk NMIBC who undergo TURBT. Ultimately, our findings will lead to the development of better interventions and potentially change the standard of care. TRIAL REGISTRATION: This clinical trial was prospectively registered with the UMIN Clinical Trials Registry on 1 August 2020. The reference number is UMIN000041273, and the Ethics Committee of Nara Medical University Approval ID is 2702. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05094-y. BioMed Central 2021-02-12 /pmc/articles/PMC7881486/ /pubmed/33579327 http://dx.doi.org/10.1186/s13063-021-05094-y Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Miyake, Makito
Nishimura, Nobutaka
Inoue, Takashi
Suzuki, Shota
Fujii, Tomomi
Owari, Takuya
Hori, Shunta
Nakai, Yasushi
Toritsuka, Michihiro
Nakagawa, Hitoshi
Tsukamoto, Shinji
Anai, Satoshi
Torimoto, Kazumasa
Yoneda, Tatsuo
Tanaka, Nobumichi
Fujimoto, Kiyohide
Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)
title Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)
title_full Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)
title_fullStr Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)
title_full_unstemmed Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)
title_short Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)
title_sort fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the fleber study)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7881486/
https://www.ncbi.nlm.nih.gov/pubmed/33579327
http://dx.doi.org/10.1186/s13063-021-05094-y
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