Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle-invasive Bladder Cancer: A Randomized Clinical Trial.
Bladder tumor
Laser
Non–muscle-invasive bladder cancer
Resection
Transurethral resection of bladder tumor
Journal
European urology focus
ISSN: 2405-4569
Titre abrégé: Eur Urol Focus
Pays: Netherlands
ID NLM: 101665661
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
received:
22
08
2020
revised:
01
11
2020
accepted:
05
12
2020
pubmed:
3
1
2021
medline:
14
4
2022
entrez:
2
1
2021
Statut:
ppublish
Résumé
En-bloc resection of bladder tumors achieves complete tumor removal, improves the quality of resection, decreases perioperative complication, and potentially improves recurrence rates. To assess the efficacy and safety of holmium laser en-bloc resection (HolERBT) versus conventional transurethral resection of bladder tumor (cTURBT). Between September 2015 and September 2018, 100 patients with non-muscle-invasive bladder cancer were randomly allocated to cTURBT or HolERBT. The primary endpoint was detection of residual tumor in reTURBT specimens at 4 wk after the primary resection. Operative parameters, specimen quality, perioperative complications, and recurrence-free survival (RFS) were compared. Independent sample t tests, χ The patient and tumor baseline characteristics were comparable between the groups. Residual tumors were detected in 7% and 27.7% of cases after HolERBT and cTURBT, respectively (p=0.01). Detrusor muscle was sampled in 98% of HolERBT and 62% of cTURBT cases (p<0.001). Lamina propria invasion substaging was feasible in only 68.2% of HolERBT and 18.4% of cTURBT cases (p<0.001). Following HolERBT, catheterization time (p<0.001) and hospital stay (p=0.001) were shorter when compared to cTURBT. Immediate postoperative instillation of chemotherapy in indicated cases was feasible for 100% of the HolERBT group and 91.5% of the cTURBT group (p=0.04). After follow-up of 20 ± 9.9 mo (13-36), RFS was 31.76 mo (95% confidence interval [CI] 28.67-34.86) in the HolERBT group and 28.25 mo (95% CI 24.87-31.64) in the cTURBT group (hazard ratio 0.43, 95% CI 0.17-1.1; p=0.07). However, this study was not powered to detect a difference in RFS. Compared to cTURBT, HolERBT is a safer procedure for bladder tumor resection. It fulfills the oncological criteria of optimized resection with less residual tumor and better specimen quality. En-bloc resection of bladder cancer tumors using a holmium laser is safer than the conventional technique. It has the advantages of less residual tumor and better specimen quality, with a similar tumor recurrence rate. This study is registered at ClinicalTrials.gov as NCT02555163.
Sections du résumé
BACKGROUND
BACKGROUND
En-bloc resection of bladder tumors achieves complete tumor removal, improves the quality of resection, decreases perioperative complication, and potentially improves recurrence rates.
OBJECTIVE
OBJECTIVE
To assess the efficacy and safety of holmium laser en-bloc resection (HolERBT) versus conventional transurethral resection of bladder tumor (cTURBT).
DESIGN, SETTING, AND PARTICIPANTS
METHODS
Between September 2015 and September 2018, 100 patients with non-muscle-invasive bladder cancer were randomly allocated to cTURBT or HolERBT.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
METHODS
The primary endpoint was detection of residual tumor in reTURBT specimens at 4 wk after the primary resection. Operative parameters, specimen quality, perioperative complications, and recurrence-free survival (RFS) were compared. Independent sample t tests, χ
RESULTS AND LIMITATIONS
CONCLUSIONS
The patient and tumor baseline characteristics were comparable between the groups. Residual tumors were detected in 7% and 27.7% of cases after HolERBT and cTURBT, respectively (p=0.01). Detrusor muscle was sampled in 98% of HolERBT and 62% of cTURBT cases (p<0.001). Lamina propria invasion substaging was feasible in only 68.2% of HolERBT and 18.4% of cTURBT cases (p<0.001). Following HolERBT, catheterization time (p<0.001) and hospital stay (p=0.001) were shorter when compared to cTURBT. Immediate postoperative instillation of chemotherapy in indicated cases was feasible for 100% of the HolERBT group and 91.5% of the cTURBT group (p=0.04). After follow-up of 20 ± 9.9 mo (13-36), RFS was 31.76 mo (95% confidence interval [CI] 28.67-34.86) in the HolERBT group and 28.25 mo (95% CI 24.87-31.64) in the cTURBT group (hazard ratio 0.43, 95% CI 0.17-1.1; p=0.07). However, this study was not powered to detect a difference in RFS.
CONCLUSIONS
CONCLUSIONS
Compared to cTURBT, HolERBT is a safer procedure for bladder tumor resection. It fulfills the oncological criteria of optimized resection with less residual tumor and better specimen quality.
PATIENT SUMMARY
RESULTS
En-bloc resection of bladder cancer tumors using a holmium laser is safer than the conventional technique. It has the advantages of less residual tumor and better specimen quality, with a similar tumor recurrence rate. This study is registered at ClinicalTrials.gov as NCT02555163.
Identifiants
pubmed: 33386289
pii: S2405-4569(20)30303-5
doi: 10.1016/j.euf.2020.12.003
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02555163']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1035-1043Informations de copyright
Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.