Most cited article - PubMed ID 37543464
En Bloc Versus Conventional Resection of Primary Bladder Tumor (eBLOC): A Prospective, Multicenter, Open-label, Phase 3 Randomized Controlled Trial
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.
- Keywords
- Bladder cancer, Diagnosis, En bloc, Energy source, Resection, Treatment,
- MeSH
- Cystectomy * methods MeSH
- Laser Therapy * methods MeSH
- Lasers, Solid-State * therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Urinary Bladder Neoplasms * surgery pathology MeSH
- Prospective Studies MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
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.
- Keywords
- EBRUC II, bladder cancer, en bloc resection, non‐muscle‐invasive bladder cancer, transurethral resection of bladder tumour,
- MeSH
- Cystectomy * methods adverse effects MeSH
- Single-Blind Method MeSH
- Middle Aged MeSH
- Humans MeSH
- Urinary Bladder Neoplasms * surgery pathology MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Transurethral Resection of Bladder MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
PURPOSE: To learn about the history and development of en bloc resection of bladder tumour (ERBT), and to discuss its future directions in managing bladder cancer. METHODS: In this narrative review, we summarised the history and early development of ERBT, previous attempts in overcoming the tumour size limitation, consolidative effort in standardising the ERBT procedure, emerging evidence in ERBT, evolving concepts in treating large bladder tumours, and the future directions of ERBT. RESULTS: Since the first report on ERBT in 1980, there has been tremendous advancement in terms of its technique, energy modalities and tumour retrieval methods. In 2020, the international consensus statement on ERBT has been developed and it serves as a standard reference for urologists to practise ERBT. Recently, high-quality evidence on ERBT has been emerging. Of note, the EB-StaR study showed that ERBT led to a reduction in 1-year recurrence rate from 38.1 to 28.5%. An individual patient data meta-analysis is currently underway, and it will be instrumental in defining the true value of ERBT in treating non-muscle-invasive bladder cancer. For large bladder tumours, modified approaches of ERBT should be accepted, as the quality of resection is more important than a mere removal of tumour in one piece. The global ERBT registry has been launched to study the value of ERBT in a real-world setting. CONCLUSION: ERBT is a promising surgical technique in treating bladder cancer and it has gained increasing interest globally. It is about time for us to embrace this technique in our clinical practice.
- Keywords
- Bladder cancer, ERBT, En bloc resection, NMIBC, TURBT, Transurethral resection,
- MeSH
- Cystectomy methods MeSH
- Humans MeSH
- Meta-Analysis as Topic MeSH
- Urinary Bladder pathology MeSH
- Urinary Bladder Neoplasms * surgery pathology MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH