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磁共振成像和超声检查在早期宫颈癌术前盆腔分期中的应用:SENTIX研究的事后分析

Magnetic resonance imaging and ultrasound examination in preoperative pelvic staging of early-stage cervical cancer: post-hoc analysis of SENTIX study.

作者信息

Cibula D, Köhler C, Jarkovský J, Kocián R, Dundr P, Klát J, Zapardiel I, Landoni F, Frühauf F, Fischbach R, Borčinová M, Fischerová D

机构信息

Department of Gynecology, Obstetrics and Neonatology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.

Department of Gynecology, Asklepios Clinic Hamburg Altona, Berlin, Germany.

出版信息

Ultrasound Obstet Gynecol. 2025 Apr;65(4):495-502. doi: 10.1002/uog.29205. Epub 2025 Mar 25.

Abstract

OBJECTIVES

SENTIX was a prospective, single-arm, international multicenter study that evaluated sentinel lymph node biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer. We aimed to evaluate the concordance between preoperative imaging modalities (magnetic resonance imaging (MRI) and ultrasound) and final pathology in the clinical staging of early-stage cervical cancer by post-hoc analysis of the SENTIX study data.

METHODS

In total, 47 sites across 18 countries participated in the SENTIX study. Patients with Stage IA1/lymphovascular space invasion-positive to IB2 (International Federation of Gynecology and Obstetrics (FIGO) classification (2018)) cervical cancer, with usual histological types and no suspicious lymph nodes on imaging, were prospectively enrolled between May 2016 and October 2020. Preoperative pelvic clinical staging on either pelvic MRI or ultrasound examination was mandatory. Tumor size discrepancy (< 10 mm vs ≥ 10 mm) between imaging and pathology, as well as the negative predictive value (NPV) of MRI and ultrasound for parametrial involvement and lymph node macrometastasis, were analyzed.

RESULTS

Among 690 eligible prospectively enrolled patients, MRI and ultrasound were used as the staging imaging modality in 322 (46.7%) and 298 (43.2%) patients, respectively. A discrepancy of tumor size ≥ 10 mm was reported between ultrasound and final pathology in 39/298 (13.1%) patients and between MRI and pathology in 53/322 (16.5%), with no significant difference in the accuracy of tumor measurement between the two imaging modalities. The NPV of ultrasound in assessing parametrial infiltration and lymph node involvement was 97.0% (95% CI, 0.95-0.99%) and 94.0% (95% CI, 0.91-0.97%), respectively, and that of MRI was 95.3% (95% CI, 0.93-0.98%) and 94.1% (95% CI, 0.92-0.97%), respectively, with no significant differences between the parameters. Ultrasound and MRI were comparable regarding the tumor size measurement (P = 0.452), failure to detect parametrial involvement (P = 0.624) and failure to detect macrometastases in sentinel lymph node (P = 0.876).

CONCLUSIONS

Pelvic ultrasound examination and MRI had similar concordance with histology in the assessment of tumor size and of parametrial and lymph node invasion in early-stage cervical cancer. Ultrasound examination should be considered part of preoperative pelvic clinical staging in early-stage cervical cancer, especially in limited-resource regions where MRI is unavailable. © 2025 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

摘要

目的

SENTIX是一项前瞻性、单臂、国际多中心研究,评估早期宫颈癌患者前哨淋巴结活检而不进行盆腔淋巴结清扫术的情况。我们旨在通过对SENTIX研究数据的事后分析,评估术前成像模式(磁共振成像(MRI)和超声)与早期宫颈癌临床分期最终病理结果之间的一致性。

方法

18个国家的47个研究点参与了SENTIX研究。2016年5月至2020年10月期间,前瞻性纳入了组织学类型常见、影像学上无可疑淋巴结的IA1期/伴有脉管间隙浸润阳性至IB2期(国际妇产科联盟(FIGO)分类(2018))宫颈癌患者。术前必须进行盆腔MRI或超声检查以进行盆腔临床分期。分析了成像与病理之间的肿瘤大小差异(<10mm对比≥10mm),以及MRI和超声对宫旁组织受累和淋巴结大转移的阴性预测值(NPV)。

结果

在690例符合条件的前瞻性纳入患者中,分别有322例(46.7%)和298例(43.2%)患者将MRI和超声用作分期成像模式。在298例患者中,有39例(13.1%)超声与最终病理结果之间的肿瘤大小差异≥10mm,在322例患者中有53例(16.5%)MRI与病理结果之间存在差异,两种成像模式在肿瘤测量准确性方面无显著差异。超声评估宫旁浸润和淋巴结受累的NPV分别为97.0%(95%CI,0.95 - 0.99%)和94.0%(95%CI,0.91 - 0.97%),MRI的NPV分别为95.3%(95%CI,0.93 - 0.98%)和94.1%(95%CI,0.92 - 0.97%),各参数之间无显著差异。超声和MRI在肿瘤大小测量(P = 0.452)、未能检测出宫旁组织受累(P = 0.624)以及未能检测出前哨淋巴结大转移(P = 0.876)方面具有可比性。

结论

盆腔超声检查和MRI在评估早期宫颈癌肿瘤大小、宫旁组织和淋巴结浸润方面与组织学具有相似的一致性。超声检查应被视为早期宫颈癌术前盆腔临床分期的一部分,尤其是在无法进行MRI检查的资源有限地区。© 2025作者。《妇产科超声》由约翰·威利父子有限公司代表国际妇产科超声学会出版。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3051/11961100/835389334d98/UOG-65-495-g002.jpg

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