Evaluation of diagnostic strategies for bladder cancer using computed tomography (CT) urography, flexible cystoscopy and voided urine cytology: results for 778 patients from a hospital haematuria clinic
Evaluation of diagnostic strategies for bladder cancer using computed tomography (CT) urography, flexible cystoscopy and voided urine cytology: results for 778 patients from a hospital haematuria clinic
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DOI：
10.1111/j.1464-410x.2011.10664.x
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发表时间：
2012-07-01
影响因子：
4.5
通讯作者：
Cowan, Nigel C.
中科院分区：
文献类型：
--
作者：
Blick, Christopher G. T.;Nazir, Sarfraz A.;Cowan, Nigel C.
目的评价和比较柔性膀胱镜下CT尿路造影与空尿细胞学对膀胱癌的诊断准确性。评估使用CT尿路造影的诊断策略：(i)作为一种附加测试或（ii）替代测试或（iii）对转诊到医院血尿快速诊断诊所的患者诊断膀胱癌的分诊测试。患者和方法临床队列包括2004年3月1日至2007年12月17日在医院血尿快速诊断诊所转诊的连续778例患者。转诊标准为至少一次肉眼血尿发作，年龄在bb0 - 40岁之间，排除尿路感染。在778例患者中，有747例进行了技术上足够的CT尿路造影和灵活的膀胱镜检查以供分析。同日，患者接受临床专科护士检查，随后进行空尿细胞学检查、CT尿路造影和柔性膀胱镜检查。空尿细胞学采用5分制评分。CT尿路造影立即由泌尿科医生报告，柔性膀胱镜检查由泌尿科医生进行。两项考试均采用三分制评分：1分正常；2、模棱两可;第三，膀胱癌呈阳性。参考标准包括2009年12月对所有患者的医院成像和组织病理学数据库的审查，以及转介进行硬性膀胱镜检查的患者的医疗记录报告。随访21 ~ 66个月。结果本组患者膀胱癌患病率为20%（156/778）。采用CT尿路造影作为诊断膀胱癌的附加检查，当1分为阴性，2分和3分为阳性时，敏感性为1.0(95%可信区间[CI] 0.98-1.00)，特异性为0.94 (95% CI 0.91-0.95)，阳性预测值（PPV）为0.80 (95% CI 0.73-0.85)，阴性预测值（NPV）为1.0 （95% CI 0.99-1.00）。对于使用CT尿路造影替代柔性膀胱镜诊断膀胱癌的诊断策略，当1分为阴性，2分和3分为阳性时，敏感性为0.95 (95% CI 0.90-0.97)，特异性为0.83 (95% CI 0.80-0.86)， PPV为0.58 (95% CI 0.52-0.64)， NPV为0.98 （95% CI 0.97-0.99）。同样，使用柔性膀胱镜诊断膀胱癌，如果1分为阴性，2分和3分为阳性，则敏感性为0.98 (95% CI 0.94- 0.99)，特异性为0.94 (95% CI 0.92-0.96)， PPV为0.80 (95% CI 0.73-0.85)， NPV为0.99 （95% CI 0.99-1.0）。对于采用CT尿路造影和柔性膀胱镜作为刚性膀胱镜检查和随访的分诊检查（选项1）的诊断策略，CT尿路造影评分阳性的患者直接转诊刚性膀胱镜检查，评分不明确或正常的患者转诊柔性膀胱镜检查。敏感性为1.0 (95% CI 0.98-1.0)，特异性为0.94 (95% CI 0.91-0.95)， PPV为0.80 (95% CI 0.73-0.85)， NPV为1.0 （95% CI 0.99-1.0）。采用CT尿路造影和软性膀胱镜作为硬性膀胱镜和随访的分诊方法（方案2），CT尿路造影评分阳性的患者直接行硬性膀胱镜检查，评分模棱两可的患者行软性膀胱镜检查，评分正常的患者进行临床随访。敏感性为0.95 (95% CI 0.90-0.97)，特异性为0.98 (95% CI 0.97-0.99)， PPV为0.93 (95% CI 0.87-0.96)， NPV为0.99 （95% CI 0.97-0.99）。对于空尿细胞学，如果0-3分为阴性，4-5分为膀胱癌阳性，则敏感性为0.38 (95% CI 0.31-0.45)，特异性为0.98 (95% CI 0.97-0.99)， PPV为0.82 (95% CI 0.72-0.88)， NPV为0.84 （95% CI 0.81-0.87）。结论采用CT尿路造影和柔性膀胱镜作为刚性膀胱镜检查和随访的分诊检查（选择1）有明显的优势，其中膀胱癌CT尿路造影评分阳性的患者直接行刚性膀胱镜检查，其他患者均行柔性膀胱镜检查。诊断准确性与附加检查策略相同，优点是可减少17%的柔性膀胱镜检查次数。空尿细胞学的敏感性太低，不足以证明其在医院血尿快速诊断临床继续使用CT尿路造影和柔性膀胱镜检查。
OBJECTIVESTo evaluate and compare the diagnostic accuracy of computed tomography (CT) urography with flexible cystoscopy and voided urine cytology for diagnosing bladder cancer.To evaluate diagnostic strategies using CT urography as: (i) an additional test or (ii) a replacement test or (iii) a triage test for diagnosing bladder cancer in patients referred to a hospital haematuria rapid diagnosis clinic.PATIENTS AND METHODSThe clinical cohort consisted of a consecutive series of 778 patients referred to a hospital haematuria rapid diagnosis clinic from 1 March 2004 to 17 December 2007. Criteria for referral were at least one episode of macroscopic haematuria, age >40 years and urinary tract infection excluded. Of the 778 patients, there were 747 with technically adequate CT urography and flexible cystoscopy examinations for analysis.On the same day, patients underwent examination by a clinical nurse specialist followed by voided urine cytology, CT urography and flexible cystoscopy. Voided urine cytology was scored using a 5-point system. CT urography was reported immediately by a uroradiologist and flexible cystoscopy performed by a urologist. Both examinations were scored using a 3-point system: 1, normal; 2, equivocal; and 3, positive for bladder cancer.The reference standard consisted of review of the hospital imaging and histopathology databases in December 2009 for all patients and reports from the medical notes for those referred for rigid cystoscopy. Follow-up was for 21-66 months.RESULTSThe prevalence of bladder cancer in the clinical cohort was 20% (156/778). For the diagnostic strategy using CT urography as an additional test for diagnosing bladder cancer, when scores of 1 were classified as negative and scores of 2 and 3 as positive, sensitivity was 1.0 (95% confidence interval [CI] 0.98-1.00), specificity was 0.94 (95% CI 0.91-0.95), the positive predictive value (PPV) was 0.80 (95% CI 0.73-0.85) and the negative predictive value (NPV) was 1.0 (95% CI 0.99-1.00).For the diagnostic strategy using CT urography as a replacement test for flexible cystoscopy for diagnosing bladder cancer, when scores of 1 were classified as negative and scores of 2 and 3 as positive, sensitivity was 0.95 (95% CI 0.90-0.97), specificity was 0.83 (95% CI 0.80-0.86), the PPV was 0.58 (95% CI 0.52-0.64), and the NPV was 0.98 (95% CI 0.97-0.99). Similarly using flexible cystoscopy for diagnosing bladder cancer, if scores of 1 were classified as negative and scores of 2 and 3 as positive, sensitivity was 0.98 (95% CI 0.94- 0.99), specificity was 0.94 (95% CI 0.92-0.96), the PPV was 0.80 (95% CI 0.73-0.85) and the NPV was 0.99 (95% CI 0.99-1.0).For the diagnostic strategy using CT urography and flexible cystoscopy as a triage test for rigid cystoscopy and follow-up (option 1), patients with a positive CT urography score are referred directly for rigid cystoscopy, and patients with an equivocal or normal score were referred for flexible cystoscopy. Sensitivity was 1.0 (95% CI 0.98-1.0), specificity was 0.94 (95% CI 0.91-0.95), the PPV was 0.80 (95% CI 0.73-0.85), and the NPV was 1.0 (95% CI 0.99-1.0).For the diagnostic strategy using CT urography and flexible cystoscopy as a triage test for rigid cystoscopy and follow-up (option 2), patients with a positive CT urography score are referred directly for rigid cystoscopy, patients with an equivocal score are referred for flexible cystoscopy and patients with a normal score undergo clinical follow-up. Sensitivity was 0.95 (95% CI 0.90-0.97), specificity was 0.98 (95% CI 0.97-0.99), the PPV was 0.93 (95% CI 0.87-0.96), and the NPV was 0.99 (95% CI 0.97-0.99).For voided urine cytology, if scores of 0-3 were classified as negative and 4-5 as positive for bladder cancer, sensitivity was 0.38 (95% CI 0.31-0.45), specificity was 0.98 (95% CI 0.97-0.99), the PPV was 0.82 (95% CI 0.72-0.88) and the NPV was 0.84 (95% CI 0.81-0.87).CONCLUSIONSThere is a clear advantage for the diagnostic strategy using CT urography and flexible cystoscopy as a triage test for rigid cystoscopy and follow-up (option 1), in which patients with a positive CT urography score for bladder cancer are directly referred for rigid cystoscopy, but all other patients undergo flexible cystoscopy.Diagnostic accuracy is the same as for the additional test strategy with the advantage of a 17% reduction of the number of flexible cystoscopies performed.The sensitivity of voided urine cytology is too low to justify its continuing use in a hospital haematuria rapid diagnosis clinic using CT urography and flexible cystoscopy.