BACKGROUND: En bloc transurethral resection of the bladder (eTURB) might improve the surgical management of non-muscle-invasive bladder cancer (NMIBC) in comparison to conventional TURB (cTURB). OBJECTIVE: To evaluate whether eTURB is superior to cTURB in resection of NMIBC and specimen retrieval. DESIGN, SETTING, AND PARTICIPANTS: This was a randomized, multicenter trial in patients with up to three cTa-T1 NMIBC tumors of 1-3 cm in size, who were enrolled from January 2019 to January 2022. INTERVENTION: Participants were randomized 1:1 to undergo eTURB (n = 192) or cTURB (n = 192). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the prevalence of detrusor muscle (DM) in the specimen retrieved. Secondary endpoints included bladder perforation, persistent disease at second-look TURB, positive lateral resection margin, positive deep resection margin, operation time, perforation rate, obturator reflex, conversion from eTURB to cTURB, recurrence-free survival, and disease recurrence at 3 mo. RESULTS AND LIMITATIONS: A total of 384 patients were randomized to undergo eTURB or cTURB. A total of 452 tumors were resected and analyzed for the primary outcome. eTURB was superior to cTURB in retrieval of DM (80.7% vs 71.1%; mixed-model p = 0.01). Bladder perforation (5.6% vs 12%; difference -6.4%; 95% confidence interval [CI] -12.2% to -0.6%) and obturator reflex (8.4% vs 16%; difference -7.6%; 95% CI -14.3% to -0.9%) were less frequent in the eTURB arm than in the cTURB arm. Operation time did not differ between the two techniques (26 min, interquartile range [IQR] 20-38 for eTURB vs 25 min, IQR 17-35 for cTURB; difference 1 min, 95% CI -25.9 to 4.99). Second-look TURB was performed in 24 patients in the eTURB arm and 34 in the cTURB arm, with no difference in the rate of residual papillary disease (pTa/pT1: 56% vs 55.9%; difference 0.1%, 95% CI -25.5% to 25.7%). At median follow-up of 13 mo (IQR 7-20), 18.4% of the patients in the eTURB arm and 16.7% in the cTURB arm had experienced bladder cancer recurrence (Cox hazard ratio 0.87, 95% CI 0.49-1.52; p = 0.6). CONCLUSIONS: In patients with clinical NMIBC with up to three tumors of 1-3 cm in size, tumor removal via eTURB resulted in a higher rate of DM in the pathologic specimen in comparison to cTURB. Moreover, eTURB was associated with lower frequency of obturator reflex and bladder perforation than cTURB was. While improving on the quality indicators for NMIBC, the long-term differential oncologic benefits of eTURB remain uncertain. PATIENT SUMMARY: We compared two techniques for removal of bladder tumors and found that tumor removal in a single piece, called en bloc resection, provides a better-quality specimen for pathology analysis and fewer complications in comparison to the conventional method. This trial is registered at ClinicalTrials.gov as NCT03718754.

• MeSH
• cystektomie * metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory močového měchýře * chirurgie   patologie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze III MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

PURPOSE: To comprehensively evaluate the efficacy of different energy sources used for en-bloc transurethral resection of bladder tumors (ERBT) on perioperative outcomes. METHODS: This sub-analysis derived from a prospective randomized study that enrolled patients undergoing ERBT vs conventional transurethral resection of the bladder (cTURB) from January 2019 to January 2022 (NCT03718754). Endpoints were pathological specimen quality and perioperative outcomes after either monopolar (m-ERBT) or bipolar (b-ERBT) or laser (l-ERBT) ERBT. RESULTS: 237 bladder tumors resected in 188 patients included in the analyses: 29 (12.2%) m-ERBT, 136 (57.4%) b-ERBT and 72 (30.4%) l-ERBT. Detrusor muscle (DM) was detected in 191 (80.6%) specimens. Per-tumor analysis revealed comparable rate of DM in the specimens obtained via different energy modalities (p = 0.7). Operative time was longer in the l-ERBT cohort compared to m-ERBT and b-ERBT (p = 0.02) and no obturator nerve reflex (ONR) onset was reported. On logistic regression analysis, b-ERBT was associated with negative lateral resection margins (OR 2.81; 95% CI 1.02-7.70; p = 0.04). There was no significant association of the resection technique with perforation and conversion rates (all p > 0.05). Within a median follow up of 22mo (IQR 11-29), a total of 35 (18.6%) patients had a local recurrence. On Cox regression analysis, patients resected with b-ERBT were less likely to have a recurrence (HR 0.34; 95% CI 0.15-0.78; p = 0.01); When adjusting for established confounders, this association was confirmed (HR 0.24; 95% CI 0.10-0.60; p = 0.002). CONCLUSIONS: Different energy sources might achieve comparable perioperative outcomes. Further perspectives involve the assessment of long-term differential oncological outcomes associated with various energy modalities.

• MeSH
• cystektomie * metody   MeSH
• laserová terapie metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory močového měchýře * chirurgie   patologie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• uretra chirurgie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

BACKGROUND: En bloc resection of bladder tumor (ERBT) is an established surgical treatment method for patients with non-muscle invasive bladder cancer (NMIBC) in tumors less than 3 cm. Data regarding the efficacy and safety of ERBT on larger than 3 cm tumors are sparse and its efficacy compared to conventional transurethral resection (TURBT) remains unclear. The aim of this study was to prospectively compare the feasibility, safety and oncological outcomes of laser (Tm-fiber) ERBT and TURBT in patients with primary bladder lesions ≥3 cm. METHODS: A cohort of 45 patients who underwent surgery for primary NMIBC between February 2018 and March 2022 was collected prospectively. There was no randomization. All procedures were performed by two experienced surgeons. Inclusion criteria were as follows: age >18 years, primary Ta or T1 bladder tumor with a diameter of ≥3 cm, no more than 3 tumors and no history of upper tract urothelial carcinoma. Exclusion criteria were carcinoma in situ or invasion into muscle layer (≥T2). ERBT was performed with thulium fiber laser (IPG, Russia). Primary endpoints included efficacy with recurrence-free survival (RFS) at 3, 6 and 12 months. Secondary endpoints were safety parameters, perioperative data and specimen quality (the presence of muscle layer in specimens). RESULTS: Twenty-eight patients underwent laser ERBT and 17 conventional TURBT. The location and size of the tumors were comparable in both groups. The success rate was 93.3% in the ERBT group with two cases of conversion from ERBT to TURBT. Detrusor muscle was present in 92.8% patients in the ERBT group versus 70.5% in the TURBT group (P=0.04). Obturator nerve reflex was observed only in the TURBT group: 17.6% vs. 0.0% (P=0.02). The frequency of other complications was comparable between the two groups. RFS was not statistically different between the two methods at 3 (93.9% vs. 94.1%, P=0.87), 6 (89.3% vs. 82.3%, P=0.5) and 12 months (89.3% vs. 70.6%, P=0.11). CONCLUSIONS: Laser ERBT is a feasible and safe procedure to manage bladder tumors larger than 3 cm. While it seems safer than TURBT, its effect on efficacy remains to be assessed in larger trials.

• MeSH
• cystektomie * metody   MeSH
• laserová terapie * metody   škodlivé účinky   přístrojové vybavení   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory močového měchýře * chirurgie   patologie   radioterapie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• studie proveditelnosti MeSH
• tumor burden MeSH
• uretra chirurgie   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH