An International Collaborative Consensus Statement on En Bloc Resection of Bladder Tumour Incorporating Two Systematic Reviews, a Two-round Delphi Survey, and a Consensus Meeting
Por:
Teoh, JYC, MacLennan, S, Chan, VWS, Miki, J, Lee, HY, Chiong, E, Lee, LS, Wei, Y, Yuan, YH, Yu, CP, Chow, WK, Poon, DMC, Chan, R, Lai, F, Ng, CF, Breda, A, Kramer, MW, Malavaud, B, Mostafid, H, Herrmann, T, Babjuk, M
Publicada:
1 oct 2020
Resumen:
Background: There has been increasing interest in en bloc resection of bladder tumour (ERBT) as an oncologically noninferior alternative to transurethral resection of bladder tumour (TURBT) with fewer complications and better histology specimens. However, there is a lack of robust randomised controlled trial (RCT) data for making recommendations.
Objective: We aimed to develop a consensus statement to standardise various aspects of ERBT for clinical practice and to guide future research.
Design, setting, and participants: We developed the consensus statement on ERBT using a modified Delphi method. First, two systematic reviews were performed to investigate the clinical effectiveness of ERBT versus TURBT (effectiveness review) and to identify areas of uncertainty in ERBT (uncertainties review). Next, 200 health care professionals (urologists, oncologists, and pathologists) with experience in ERBT were invited to complete a two-round Delphi survey. Finally, a 16-member consensus panel meeting was held to review, discuss, and re-vote on the statements as appropriate.
Outcome measurements and statistical analysis: Meta-analyses were performed for RCT data in the effectiveness review. Consensus statements were developed from the uncertainties review. Consensus was defined as follows: (1) >= 70% scoring a statement 7-9 and <= 15% scoring the statement 1-3 (consensus agree), or (2) >= 70% scoring a statement 1-3 and <= 15% scoring the statement 7-9 (consensus disagree).
Results and limitations: A total of 10 RCTs were identified upon systematic review. ERBT had a shorter irrigation time (mean difference -7.24 h, 95% confidence interval [CI] -9.29 to -5.20, I-2 = 85%, p < 0.001) and a lower rate of bladder perforation (risk ratio 0.30, 95% CI 0.11-0.83, I-2 = 1%, p = 0.02) than TURBT, both with moderate certainty of evidence. There were no significant differences in recurrences at 0-12, 13-24, or 25-36 mo (all very low certainty of evidence). A total of 103 statements were developed, of which 99 reached a consensus. A summary of statements is as follows: ERBT should always be considered for treating non-muscle-invasive bladder cancer; ERBT should be considered feasible even for bladder tumours larger than 3 cm; number and location of bladder tumours are not major limitations in performing ERBT; the planned circumferential margin should be at least 5 mm from any visible bladder tumour; after ERBT, additional biopsy of the tumour edge or tumour base should not be performed routinely; for the ERBT specimen, T1 substage, and circumferential and deep resection margins must be assessed; it is safe to give a single dose of immediate intravesical chemotherapy, perform second-look transurethral resection, and give intravesical bacillus Calmette-Guerin (BCG) therapy after ERBT; and in studies of ERBT, both per-patient and -tumour analysis should be performed for different outcomes as appropriate. Important outcomes for future ERBT studies were also identified. A limitation is that as consensus statements are brief, concise and binary in nature, areas of uncertainty that are complex in nature may not be addressed adequately.
Conclusions: We have provided the most comprehensive review of the evidence base to date using a meta-analysis where appropriate and applying the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, and mobilised the international urology community to develop a consensus statement on ERBT using transparent and robust methods. The consensus statement will provide interim guidance for health care professionals who practice ERBT and inform researchers regarding ERBT-related studies in the future.
Patient summary: En bloc resection of bladder tumour (ERBT) is a surgical technique aiming to resect a bladder tumour in one piece. We included an international panel of experts to agree on the best practice of ERBT, and this will provide guidance to clinicians and researchers in the future. (C) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Filiaciones:
Teoh, JYC:
Chinese Univ Hong Kong, SH Ho Urol Ctr, Dept Surg, Hong Kong, Peoples R China
MacLennan, S:
Univ Aberdeen, Acad Urol Unit, Aberdeen, Scotland
Chan, VWS:
Univ Leeds, Fac Med & Hlth, Sch Med, Leeds, W Yorkshire, England
Miki, J:
Jikei Univ, Kashiwa Hosp, Dept Urol, Sch Med, Kashiwa, Chiba, Japan
Lee, HY:
Kaohsiung Municipal Tatung Hosp, Urol Dept, Kaohsiung, Taiwan
Chiong, E:
Natl Univ Hlth Syst, Natl Univ Hosp, Dept Urol, Singapore, Singapore
Lee, LS:
Sengkang Gen Hosp, Dept Surg, Urol Serv, Singapore, Singapore
Singapore Gen Hosp, Dept Urol, Singapore, Singapore
Wei, Y:
Fujian Med Univ, Affiliated Hosp 1, Dept Urol, Fuzhou, Fujian, Peoples R China
Yuan, YH:
McMaster Univ, Dept Med, Hamilton, ON, Canada
Yu, CP:
Chinese Univ Hong Kong, Li Ping Med Lib, Hong Kong, Peoples R China
Chow, WK:
New Terr East Cluster Bladder Canc Support Grp, Hong Kong, Peoples R China
Poon, DMC:
Chinese Univ Hong Kong, Dept Clin Oncol, Hong Kong, Peoples R China
Chan, R:
Chinese Univ Hong Kong, Dept Anat & Cellular Pathol, Hong Kong, Peoples R China
Lai, F:
Chinese Univ Hong Kong, Dept Anat & Cellular Pathol, Hong Kong, Peoples R China
Ng, CF:
Chinese Univ Hong Kong, SH Ho Urol Ctr, Dept Surg, Hong Kong, Peoples R China
Breda, A:
Univ Autonoma Barcelona, Fdn Puigvert, Dept Urol, Barcelona, Spain
Kramer, MW:
Univ Hosp Schleswig Holstein, Dept Urol, Campus Luebeck, Lubeck, Germany
Malavaud, B:
Inst Univ Canc, Dept Urol, Toulouse, France
Mostafid, H:
Royal Surrey Cty Hosp, Dept Urol, Guildford, Surrey, England
Herrmann, T:
Spital Thurgau AG, Dept Urol, Frauenfeld, Switzerland
Hanover Med Sch MHH, Dept Urol, Hanover, NH USA
Babjuk, M:
Charles Univ Prague, Hosp Motol, Fac Med 2, Dept Urol, Prague, Czech Republic
Med Univ Vienna, Vienna, Austria
Green Submitted
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