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在一项随机临床试验中,术前磁共振成像是否降低了根治性前列腺切除术的阳性手术切缘率?

Does preoperative magnetic resonance imaging reduce the rate of positive surgical margins at radical prostatectomy in a randomised clinical trial?

机构信息

Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

Department of Urology, Oslo University Hospital, Oslo, Norway.

出版信息

Eur Urol. 2015 Sep;68(3):487-96. doi: 10.1016/j.eururo.2015.02.039. Epub 2015 Mar 23.

DOI:10.1016/j.eururo.2015.02.039
PMID:25813692
Abstract

BACKGROUND

Magnetic resonance imaging (MRI) has the potential to help the surgeon tailor radical prostatectomy (RP) more accurately according to the location and extent of the tumour and thereby reduce the rate of positive surgical margins (PSMs).

OBJECTIVE

To evaluate the benefit of performing MRI prior to RP.

DESIGN, SETTING, AND PARTICIPANTS: This single-institution randomised trial included 438 patients between December 2009 and June 2012 who were scheduled for robot-assisted laparoscopic prostatectomy. The study was registered (ClinicalTrials.gov identifier NCT01347320).

INTERVENTION

Patients were preoperatively randomly assigned to non-MRI or MRI groups.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary end point was the difference in the PSM rates between the two groups. Secondary end points were the rates of PSMs in clinical subgroups. Summary statistics were extracted from descriptive analyses, chi-square, or Fisher exact test, and logistic regression was used to analyse the data according to the intention-to-treat principle.

RESULTS AND LIMITATIONS

A total of 216 patients were randomised to non-MRI; 222 were randomised to MRI. There were 49 cases (23%) of PSMs in the non-MRI group and 43 cases (19%) in the MRI group (p=0.4). The relative and absolute risk reduction was 15% and 4%, respectively. Patients with cT1 constituted 55% of the cohort, in which the rate of PSMs was 27% in the non-MRI group and 16% in the MRI group (p=0.035). The relative and absolute risk reduction was 41% and 11%, respectively. A limitation was suboptimal communication between the radiologist and urologist.

CONCLUSIONS

MRI prior to RP did not reduce the overall risk for PSMs in this patient cohort. However, at subgroup analysis we observed a possible benefit of MRI in patients with cT1.

PATIENT SUMMARY

This study could not demonstrate a definite benefit of performing magnetic resonance imaging before surgery for all patients. However, there was a possible improved result in patients in which physical examination could not detect the cancer.

摘要

背景

磁共振成像(MRI)有可能帮助外科医生根据肿瘤的位置和范围更准确地进行根治性前列腺切除术(RP),从而降低切缘阳性率(PSMs)。

目的

评估 RP 前进行 MRI 的益处。

设计、地点和参与者:这项单机构随机试验纳入了 2009 年 12 月至 2012 年 6 月间计划行机器人辅助腹腔镜前列腺切除术的 438 名患者。该研究已注册(ClinicalTrials.gov 标识符 NCT01347320)。

干预

患者术前被随机分配至非 MRI 或 MRI 组。

主要终点

两组间 PSM 率的差异。次要终点为各临床亚组的 PSM 率。从描述性分析、卡方或 Fisher 确切检验中提取汇总统计量,并根据意向治疗原则使用逻辑回归进行数据分析。

结果和局限性

共有 216 名患者被随机分配至非 MRI 组,222 名患者被随机分配至 MRI 组。非 MRI 组中 49 例(23%)发生 PSM,MRI 组中 43 例(19%)发生 PSM(p=0.4)。相对风险降低 15%,绝对风险降低 4%。cT1 患者占队列的 55%,非 MRI 组和 MRI 组的 PSM 率分别为 27%和 16%(p=0.035)。相对风险降低 41%,绝对风险降低 11%。局限性在于放射科医生和泌尿科医生之间的沟通欠佳。

结论

在本患者队列中,RP 前进行 MRI 并未降低 PSM 的总体风险。但是,亚组分析显示 MRI 对 cT1 患者可能有益。

患者总结

这项研究未能证明所有患者手术前进行 MRI 有明确的获益。然而,在体格检查无法检测到癌症的患者中,可能会有更好的结果。

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