Does Preoperative Magnetic Resonance Imaging Reduce the Rate of Positive Surgical Margins at Radical Prostatectomy in a Randomised Clinical Trial?
Does Preoperative Magnetic Resonance Imaging Reduce the Rate of Positive Surgical Margins at Radical Prostatectomy in a Randomised Clinical Trial?
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DOI：
10.1016/j.eururo.2015.02.039
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发表时间：
2015-09-01
期刊：
影响因子：
23.4
通讯作者：
Eri, Lars Magne
中科院分区：
文献类型：
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作者：
Rud, Erik;Baco, Eduard;Eri, Lars Magne
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定制根治性前列腺切除术（RP），从而降低手术切缘阳性（psm）的比率。目的：评价RP术前MRI的疗效。设计、环境和参与者：这项单机构随机试验包括438名患者，时间为2009年12月至2012年6月，计划接受机器人辅助腹腔镜前列腺切除术。该研究已注册（ClinicalTrials.gov识别码NCT01347320）。干预：患者术前随机分为非MRI组和MRI组。结果测量和统计分析：主要终点是两组间PSM发生率的差异。次要终点是临床亚组中psm的发生率。从描述性分析、卡方检验或Fisher精确检验中提取汇总统计数据，并根据意向-治疗原则使用逻辑回归分析数据。结果和局限性：共有216例患者被随机分配到非mri组；222例随机接受MRI检查。非MRI组psm 49例（23%），MRI组43例（19%）（p = 0.4）。相对和绝对风险分别降低15%和4%。cT1患者占队列的55%，其中非MRI组psm发生率为27%，MRI组为16% （p = 0.035）。相对和绝对风险分别降低41%和11%。一个限制是放射科医生和泌尿科医生之间的沟通不理想。结论：RP之前的MRI并没有降低该患者队列中psm的总体风险。然而，在亚组分析中，我们观察到MRI对cT1患者可能有好处。患者总结：本研究不能证明术前进行磁共振成像对所有患者都有明确的益处。然而，对于那些身体检查无法发现癌症的患者来说，结果可能会有所改善。(C) 2015年欧洲泌尿外科协会。Elsevier B.V.出版
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. (C) 2015 European Association of Urology. Published by Elsevier B.V.