Fusion Imaging Navigation Combined with Contrast-Enhanced Ultrasound in the Diagnosis of Clinically Significant Prostate Cancer via Transperineal Targeted Biopsy
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摘要:
目的 评估多参数磁共振(multiparameter MRI,mpMRI)-经直肠超声(transrectal of ultrasound,TRUS)影像融合导航联合超声造影(contrast-enhanced ultrasound,CEUS)在经会阴靶向穿刺活检中对临床显著性前列腺癌(clinically significant prostate cancer,csPCa)的诊断效能,比较不同穿刺方案的检出差异。 方法 前瞻性纳入2023年1月至2025年12月于乐山市人民医院行前列腺穿刺活检的可疑前列腺癌患者230例。所有患者术前均行mpMRI及CEUS检查,采用MRI-TRUS影像融合导航系统行经会阴靶向穿刺。以病理结果为金标准,比较不同方案对总前列腺癌(prostate cancer,PCa)及csPCa的检出率、单针阳性率及诊断效能指标,分析CEUS增强特征与病理结果的相关性,并评估并发症发生情况。 结果 230例患者中,PCa 148例(64.35%),csPCa 116例(50.43%)。联合穿刺的PCa检出率(64.35%)和csPCa检出率(50.43%)均显著高于融合导航靶向穿刺(53.04%和47.39%)、CEUS靶向穿刺(47.39%和41.74%)及系统穿刺(50.43%和44.78%)(Cochran’ s Q=45.172,P < 0.001;Cochran’ s Q=38.296,P < 0.001)。联合穿刺诊断csPCa的敏感性为92.68%,特异性为88.79%,准确度为90.87%。单针阳性率以融合导航靶向穿刺最高(38.47%),显著高于CEUS靶向穿刺(28.12%)和系统穿刺(22.83%)(F = 18.349,P < 0.001)。前列腺影像报告和数据系统(PI-RADS)评分与csPCa检出率呈正相关,3分、4分、5分患者的csPCa检出率分别为26.87%、43.01%和82.86%(χ2趋势=46.891,P < 0.001)。CEUS阳性病灶的PCa阳性率(69.14%)显著高于阴性病灶(32.84%)(χ2=25.412,P < 0.001),CEUS峰值强度与Gleason分级/ISUP分组呈正相关(Spearman ρ = 0.621,P < 0.01) 。亚组分析显示,在PSA≤20 ng/mL的患者中,联合穿刺组的csPCa检出率显著优于系统穿刺组(PSA≤10 ng/mL:36.17% vs 20.83%,McNemar χ2=4.260,P = 0.039;PSA 10.01~20 ng/mL:48.00% vs 31.58%,McNemar χ2=4.620,P = 0.032);病灶直径>10 mm者csPCa检出率显著高于≤10 mm者(57.14% vs 31.82%,χ2=7.54,P = 0.006)。经会阴途径术后任何级别并发症发生率为23.48%,其中感染相关并发症(发热≥38.5 ℃)发生率为1.74%,显著低于文献报道的经直肠途径。 结论 MRI-TRUS影像融合联合CEUS靶向活检可显著提高csPCa检出率。联合穿刺策略的诊断效能优于单一靶向或系统穿刺,CEUS可为靶向穿刺提供功能性影像依据。对于PSA≤20 ng/mL的中低危患者,影像融合技术的增量价值更为明确,经会阴途径具有良好的安全性。 Abstract:Objective To evaluate the diagnostic performance of multi-parameter magnetic resonance (mpMRI) - transrectal ultrasound (TRUS) fusion navigation combined with contrast-enhanced ultrasound (CEUS) in transperineal targeted prostate biopsy for clinically significant prostate cancer (csPCa), and to compare detection differences among different biopsy schemes. Methods A total of 230 patients with suspected prostate cancer who underwent prostate biopsy at Leshan People 's Hospital from January 2023 to December 2025 were prospectively included. All patients underwent mpMRI and CEUS before the procedure, and transperineal targeted biopsy was performed using an MRI-TRUS fusion navigation system. With pathological findings as the gold standard, the detection rates of overall prostate cancer (PCa) and csPCa, the single-core positivity rate, and diagnostic performance metrics were compared across different biopsy schemes. The correlation between CEUS enhancement features and pathological results was analyzed, and complications were assessed. Results Among the 230 patients, PCa was detected in 148 cases (64.35%) and csPCa in 116 cases (50.43%). The combined biopsy scheme achieved significantly higher detection rates of PCa ( 64.35% ) and csPCa (50.43%) than fusion navigation-targeted biopsy (53.04% and 47.39%), CEUS-targeted biopsy (47.39% and 41.74%), and systematic biopsy (50.43% and 44.78%) (Cochran's Q = 45.172, P < 0.001; Cochran's Q = 38.296, P < 0.001). For diagnosing csPCa, combined biopsy yielded a sensitivity of 92.68%, a specificity of 88.79%, and an accuracy of 90.87%. The single-core positivity rate was highest for fusion navigation-targeted biopsy (38.47%), significantly higher than that of CEUS-targeted biopsy (28.12%) and systematic biopsy (22.83%) (F = 18.349, P < 0.001). Prostate Imaging Reporting and Data System (PI-RADS) scores were positively correlated with the csPCa detection rate, which was 26.87%, 43.01%, and 82.86% in patients with scores of 3, 4, and 5, respectively (χ2 for trend = 46.891, P < 0.001). The PCa positivity rate of CEUS-positive lesions (69.14%) was significantly higher than that of CEUS-negative lesions (32.84%) (χ2 = 25.412, P < 0.001), and CEUS peak intensity was positively correlated with Gleason grade/ISUP grade group (Spearman ρ = 0.621, P < 0.01). Subgroup analysis showed that in patients with PSA ≤ 20 ng/mL, the csPCa detection rate of combined biopsy was significantly superior to that of systematic biopsy (PSA ≤ 10 ng/mL: 36.17% vs 20.83%, McNemar χ2 = 4.260, P = 0.039; PSA 10.01–20 ng/mL: 48.00% vs 31.58%, McNemar χ2 = 4.620, P = 0.032). The csPCa detection rate in patients with lesion diameters > 10 mm was significantly higher than in those with lesions ≤ 10 mm (57.14% vs 31.82%, χ2 = 7.54, P = 0.006). The overall complication rate after the transperineal approach was 23.48%, and the incidence of infection-related complications (fever ≥ 38.5 °C) was 1.74%, significantly lower than reported in the literature for the transrectal approach. Conclusion MRI-TRUS fusion navigation combined with CEUS-targeted biopsy can significantly improve the detection rate of csPCa. The combined biopsy strategy demonstrates superior diagnostic performance over targeted biopsy alone or systematic biopsy, and CEUS can provide functional imaging evidence for targeted biopsy. For intermediate- to low-risk patients with PSA ≤ 20 ng/mL, the incremental value of fusion imaging technology is more evident, and the transperineal approach exhibits a favorable safety profile. -
表 1 两组可疑PCa患者基线特征及分组比较[($ \bar x \pm s $)/n(%)]
Table 1. Baseline characteristics and group comparison of patients with suspected PCa in the two groups[($ \bar x \pm s $)/n(%)]
临床参数 总体 (n = 230) 恶性组 (n = 148) 良性组 (n = 82) t/χ2 P 年龄(岁) 68.52 ± 7.58 69.21 ± 7.43 67.18 ± 8.12 1.831 0.068 tPSA (ng/mL) 16.93 ± 12.41 20.68 ± 13.91 9.81 ± 5.58 8.461 **<0.001 f/t PSA 0.15 ± 0.07 0.13 ± 0.06 0.18 ± 0.08 4.835 **<0.001 前列腺体积(mL) 48.72 ± 21.53 46.14 ± 19.91 53.02 ± 23.68 2.318 *0.021 PSAD(ng/mL2) 0.42 ± 0.33 0.53 ± 0.36 0.21 ± 0.15 9.357 **<0.001 PI-RADS评分 −3分 67 (29.13) 27 (18.24) 40 (48.78) 43.128 <0.001** −4分 93 (40.43) 66 (44.59) 27 (32.93) −5分 70 (30.43) 55 (37.16) 15 (18.29) *P < 0.05;**P < 0.01。 表 2 不同穿刺方案对230例患者PCa及csPCa的检出效能比较[n(%)]
Table 2. Comparison of detection performance of different biopsy schemes for PCa and csPCa in 230 patients [ n ( % ) ]
穿刺方案 PCa检出率 csPCa检出率 单针阳性率(%) 敏感性(%) 特异性(%) PPV(%) NPV(%) 准确度(%) 融合导航靶向穿刺 122(53.04) 109(47.39) 38.47 82.13 87.45 86.52 83.33 84.02 CEUS靶向穿刺 109(47.39) 96(41.74) 28.12 73.42 88.76 84.62 79.17 78.93 系统穿刺 116(50.43) 103(44.78) 22.83 78.02 84.92 81.69 81.82 80.61 联合穿刺 148(64.35) 116(50.43) 24.68 92.68 88.79 90.48 91.35 90.87 Cochran’ s Q 45.172 38.296 F = 18.349 − − − − − P **<0.001 **<0.001 **<0.001 − − − − − *P < 0.05;**P < 0.01。 表 3 不同PI-RADS评分分层的csPCa检出率比较
Table 3. Comparison of csPCa detection rates stratified by different PI-RADS scores
PI-RADS评分 例数 csPCa检出例数 csPCa检出率 (%) χ2 P 3分 67 18 26.87 48.520 **<0.001 4分 93 40 43.01 5分 70 58 82.86 合计 230 116 50.43 *P < 0.05;**P < 0.01。 表 4 不同PSA水平下联合穿刺与系统穿刺的csPCa检出率比较[n(%)]
Table 4. Comparison of csPCa detection rates between combined biopsy and systematic biopsy at different PSA levels[ n(%)]
PSA分层(ng/mL) 总N 联合穿刺csPCa 系统穿刺csPCa 差值(95%CI) McNemar χ2 P ≤10 95 17 (17.89) 10 (10.53) 7.37 (−0.2~14.9) 4.260 0.039* 10.01~20 151 36 (23.84) 24 (15.89) 7.95 (1.2~14.7) 4.620 0.032* >20 95 38 (40.00) 26 (27.37) 12.63 (−3.5~28.8) 1.010 0.341 合计 341 91 (26.69) 60 (17.60) 9.09 (4.3~13.9) 12.460 <0.001** *P < 0.05;**P < 0.01。 表 5 不同穿刺方案检出前列腺癌的病理学特征比较[($ \bar x \pm s $)/ n ( % ) ]
Table 5. Comparison of pathological features of prostate cancer detected by different biopsy schemes[($ \bar x \pm s $)/ n ( % ) ]
穿刺方案 Gleason 6
(%)Gleason 3+4
(%)Gleason 4+3
(%)Gleason ≥8
(%)肿瘤最大径
(mm)包膜外侵犯/
精囊浸润阳性率(%)融合导航靶向穿刺 18(16.51) 42(38.53) 30(27.52) 19(17.43) 14.17 ± 3.98 22.94 CEUS靶向穿刺 15(15.63) 35(36.46) 28(29.17) 18(18.75) 13.92 ± 4.21 20.83 系统穿刺 28(27.18) 38(36.89) 25(24.27) 12(11.65) 11.73 ± 3.65 15.53 联合穿刺 30(25.86) 45(38.79) 32(27.59) 20(17.24) 14.24 ± 4.05 23.28 χ2/t值 6.417 0.893 1.204 4.521 4.628 5.039 P 0.093 0.827 0.752 0.211 0.009 0.169 FFH test/F/χ2 8.537 4.628 5.039 P 0.093 0.827 0.752 0.211 0.009** 0.169 **P < 0.01。 表 6 超声造影增强特征与病理结果的相关性[n(%)]
Table 6. Correlation between contrast-enhanced ultrasound features and pathological findings [ n ( % ) ]
指标 CEUS阳性病灶 CEUS阴性病灶 χ2/t P PCa阳性率 69.14(112/162) 32.84 (22/67) 25.412 <0.001** 增强强度与Gleason分级相关性 ρ = 0.621 − − <0.01* Gleason≥8分峰值强度 (dB) 9.91 ± 1.28a − 8.490 <0.001** Gleason 6分峰值强度 (dB) 7.12 ± 1.09 − 表 7 csPCa检出的多因素Logistic回归分析
Table 7. Multivariate logistic regression analysis of csPCa detection
变量 β SE Wald χ2 P 调整OR (95%CI) PSA 0.077 0.030 6.590 0.010** 1.080 (1.020~1.150) PI-RADS评分(以3分为参照) 4分 0.967 0.435 4.941 0.026* 2.630 (1.120~6.180) 5分 2.730 0.546 25.000 <0.001** 15.340 (5.260~44.720) CEUS阳性 1.416 0.408 12.042 0.001** 4.120 (1.850~9.170) 病灶最大径>10 mm 1.115 0.443 6.336 0.012* 3.050 (1.280~7.270) 常数项 −3.852 0.684 31.728 <0.001** − *P < 0.05;**P < 0.01。 表 8 穿刺并发症发生情况
Table 8. Incidence of biopsy complications
并发症
类型例数
(n = 230)发生率
(%)Clavien-Dindo
分级血尿 39 16.96 Ⅰ级 血便 7 3.04 Ⅰ级 发热 (≥38.5 ℃) 4 1.74 Ⅱ级 尿潴留 3 1.30 Ⅱ级 会阴部血肿 1 0.43 Ⅰ级 感染性休克 0 0 − 败血症 0 0 − 合计 54 23.48 − 表 9 经会阴途径与文献报道经直肠途径操作参数及并发症的比较
Table 9. Comparison of operative parameters and complications between the transperineal approach and the transrectal approach reported in the literature
指标 本研究经会阴组(n = 230) 文献报道经直肠组[11] 术后总体并发症发生率(%) 23.48 23.61 感染相关并发症发生率(%) 1.74 3.12 穿刺时间(min) 18.94 ± 2.04 23.65 ± 2.71 术中失血量(mL) 203.12 ± 24.83 239.61 ± 27.51 -
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