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Does Urinary Cytology Have a Role in Haematuria Investigations?

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Does Urinary Cytology Have a Role in Haematuria Investigations? Does urinary cytology have a role in haematuria investigations? † ‡ † § Wei Shen Tan* , Rachael Sarpong , Pramit Khetrapal* , Simon Rodney* , ¶ †† ‡‡ Hugh Mostafid , Joanne Cresswell**, Dawn Watson**, Abhay Rane , James Hicks , §§ ¶¶ ††† Giles Hellawell , Melissa Davies , Shalom J. Srirangam***, Louise Dawson , ‡‡‡ ‡ ‡ § David Payne , Norman Williams , Chris Brew-Graves , Andrew Feber* 1, John D. †1 Kelly* and on behalf of DETECT I trial collaboratorsa † *Division of Surgery and Interventional Science, University College London, Department of Urology, University College ‡ § London Hospital, Surgical and Interventional Trials Unit, University College London, UCL Cancer Institute, London, ¶ Department of Urology, Royal Surrey County Hospital, Guildford, **Department of Urology, James Cook University †† ‡‡ Hospital, Middlesbrough, Department of Urology, East Surrey Hospital, Redhill, Department of Urology, Worthing §§ Hospital, Worthing, Department of Urology, Northwick Park Hospital, London, ¶¶Department of Urology, Salisbury ††† District Hospital, Salisbury, ***Department of Urology, East Lancashire Hospital, Blackburn, Department of Urology, ‡‡‡ Royal Bolton Hospital, Bolton, and Department of Urology, Kettering General Hospital, Kettering, UK 1Joint senior author aDETECT I trial collaborators are listed in Appendix 1 Objectives predictive value (NPV) 94.9%. A total of 21 bladder cancers and 5 UTUC were missed. Bladder cancers missed according To determine the diagnostic accuracy of urinary cytology to ≥ diagnose bladder cancer and upper tract urothelial cancer to grade and stage were as follows: 4 (19%) were pT2, 2 (9.5%) were G3 pT1, 10 (47.6%) were G3/2 pTa and 5 (UTUC) as well as the outcome of patients with a positive fi urine cytology and normal haematuria investigations in (23.8%) were G1 pTa. High-risk cancer was con rmed in 8 patients in a multicentre prospective observational study of (38%) patients. There was a marginal improvement in patients investigated for haematuria. sensitivity (57.7%) for high-risk cancers. When urine cytology was combined with imaging, the diagnostic performance Patient and methods improved with CTU (sensitivity 90.2%, specificity 94.9%) superior to RBUS (sensitivity 66.7%, specificity 96.7%). False The DETECT I study (clinicaltrials.gov NCT02676180) fi recruited patients presenting with haematuria following positive cytology results were con rmed in 22 patients, of which 12 (54.5%) had further invasive tests and 5 (22.7%) referral to secondary case at 40 hospitals. All patients had a fi cystoscopy and upper tract imaging (renal bladder ultrasound had a repeat cytology. No cancer was identi ed in these [RBUS] and/ or CT urogram [CTU]). Patients, where urine patients during follow-up. cytology were performed, were sub-analysed. The reference Conclusions standard for the diagnosis of bladder cancer and UTUC was fi histological confirmation of cancer. A positive urine cytology Urine cytology will miss a signi cant number of muscle- was defined as a urine cytology suspicious for neoplastic cells invasive bladder cancer and high-risk disease. Our results or atypical cells. suggest that urine cytology should not be routinely performed as part of haematuria investigations. The role of Results urine cytology in select cases should be considered in the Of the 3 556 patients recruited, urine cytology was performed context of the impact of a false positive result leading to in 567 (15.9%) patients from nine hospitals. Median time further potentially invasive tests conducted under general between positive urine cytology and endoscopic tumour anaesthesia. – resection was 27 (IQR: 21.3 33.8) days. Bladder cancer was Keywords diagnosed in 39 (6.9%) patients and UTUC in 8 (1.4%) patients. The accuracy of urinary cytology for the diagnosis of biomarker, cytology, diagnosis, haematuria, urine, bladder cancer and UTUC was: sensitivity 43.5%, specificity investigations, #utuc, #blcsm, #BladderCancer 95.7%, positive predictive value (PPV) 47.6% and negative © 2018 The Authors BJU Int 2019; 123: 74–81 BJU International | doi:10.1111/bju.14459 wileyonlinelibrary.com Pub. www.bjui.org This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Cytology not required for haematuria investigations within 12 weeks from study registration, were eligible for Introduction inclusion. Patients who did not consent were excluded from Cystoscopy with upper tract imaging is the recommended the study. Verbal and written consent were obtained from all investigation when evaluating patients with haematuria to patients prior to cystoscopy. identify bladder cancer or upper tract cancer. Urinary The DETECT I full trial protocol has been previously cytology is a frequently used test and has been available in reported [6]. Study protocol was approved by the Health most hospitals since it was described by Papanicolaou and Research Authority-North West Liverpool Central Research Marshall [1]. Urine cytology has a high specificity and Ethics Committee on March 2016 (IRAS ID: 179245, REC variable sensitivity (38–84%), even in high grade disease, and reference: 16/NW/0150). an even lower sensitivity for low grade bladder cancer (20– 53%) [2]. Hence, even with a high negative predictive value (NPV) of 92%, urinary cytology cannot be recommended as a Procedures standalone test [3]. A medical history and physical examination were performed. fl There is no consensus among guideline bodies regarding the All patients underwent exible cystoscopy. The choice of inclusion of urinary cytology for assessment of haematuria. upper tract imaging and use of urinary cytology was The National Institute for Health and Care Excellence (NICE) determined by local guidelines or physician preference. Upper bladder cancer guidelines do not specify investigations in tract imaging comprised renal/bladder ultrasonography patients with haematuria, but they do recommend that (RBUS) and CT urogram (CTU). Where there was a patients with a new diagnosis of bladder cancer should suspicion of bladder cancer, patients underwent a subsequent undergo one of the following: urine cytology; an alternative transurethral resection of bladder tumour or bladder biopsy urinary biomarker test (such as UroVysion using fluorescence under anaesthesia. All urine samples collected for cytology in situ hybridization [FISH], ImmunoCyt or nuclear matrix were voided samples collected prior to cystoscopy. DETECT I protein 22 [NMP22]); photodynamic diagnosis; or narrow- was a pragmatic study and investigated the role of urinary band imaging [4]. The AUA suggests that cytology may be cytology in routine practice; hence, central review was not useful for patients with persistent non-visible haematuria performed. Urine samples were sent to the receiving (NVH) after a negative evaluation or those with carcinoma laboratory, where they were centrifuged and a monolayer of in situ (CIS) risk factors (irritative voiding, current/past cells was prepared on a glass slide. Cells were then stained tobacco use, chemical exposure) [5]. Such inconsistent with Papanicolaou staining and examined by microscopy by a recommendations result in a variation in clinical practice. cytopathologist. The DETECT I study (ClinicalTrials.gov: NCT02676180) was a prospective observational study which recruited patients from 40 Outcome UK hospitals who underwent investigations for haematuria [6]. Patient demographics, ethnicity and smoking history were Urinary cytology was performed as part of routine investigations recorded. The presence of bladder cancer was confirmed by for patients referred for investigation after a presentation of histology according to TNM WHO classification [8]. haematuria at one of nine centres. In the present paper, we report Cancer risk classification was defined based on European the diagnostic ability of urinary cytology to diagnose bladder Association of Urology guidelines [9]. The reference cancer and upper tract urothelial cancer (UTUC) in patients with standard for the diagnosis of UTUC was by haematuria. A secondary aim of the study was to report the histopathological analysis. outcome of patients with positive urinary cytology after a normal cystoscopy and upper tract imaging. Urinary cytology results were classified as (i) suspicious/ consistent with neoplastic cells, (ii) atypical cells or (iii) negative for cancer. A positive/atypical urinary cytology was Methods defined as a score of ≥3 on the Paris system for reporting of Study Design urinary cytology [10]. Urine samples with inadequate cellular content were excluded from analysis. Analysis reporting the Between March 2016 and June 2017, patients were combined diagnostic performance of urinary cytology and prospectively recruited from 40 hospitals in England. All imaging is determined based on the ability of either urinary patients were referred by their GP to secondary care after cytology or imaging to detect bladder cancer or UTUC. presentation of haematuria. Visible haematuria (VH) was defined as haematuria reported by the patient, while NVH was defined as a value of ≥1+ of blood on urine dipstick on Statistical Analysis ≥2 occasions [7]. Men and women aged ≥18 years, who Continuous data were reported as descriptive statistics using consented to undergo cystoscopy and upper tract imaging mean, median, interquartile range (IQR) and 95% CI. © 2018 The Authors BJU International published by John Wiley & Sons Ltd on
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