M-O Grimm, J Bedke, J Nyarangi-Dix, W Khoder, S Foller, H-J Sommerfeld, M Giessing, M Heck, W Meißner, A Slee, K Leucht, F von Rundstedt, G Theil, S Buse, S Siemer, P Albers, C Gratzke, M Hohenfellner, A Stenzl
{"title":"开放与机器人辅助部分肾切除术在中/高复杂性肾肿瘤患者中的应用：随机、对照、开放标签、多中心试验OpeRa的最终结果","authors":"M-O Grimm, J Bedke, J Nyarangi-Dix, W Khoder, S Foller, H-J Sommerfeld, M Giessing, M Heck, W Meißner, A Slee, K Leucht, F von Rundstedt, G Theil, S Buse, S Siemer, P Albers, C Gratzke, M Hohenfellner, A Stenzl","doi":"10.1016/j.annonc.2025.04.005","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The prospective, randomised, open-label, multicentre OpeRa trial (NCT03849820) aimed to determine whether robotic-assisted partial nephrectomy (RAPN) is superior to open partial nephrectomy (OPN) in reducing 30-day post-operative complications during the treatment of intermediate/high-complexity renal tumours.</p><p><strong>Patients and methods: </strong>Eligible patients aged ≥18 years had a renal tumour suitable for OPN or RAPN, a RENAL score ≥7, and an estimated glomerular filtration rate ≥50 ml/min/1.73 m<sup>2</sup>. Patients were randomised from 15 March 2019 to 23 November 2021 in 12 German hospitals and assigned (1 : 1) to undergo RAPN or OPN. Primary endpoint was the 30-day post-operative complication rate [Clavien-Dindo (CD) I-V] in the modified intention-to-treat population. We aimed to recruit 606 patients to detect ≥10% reduction in the primary endpoint for RAPN versus OPN.</p><p><strong>Results: </strong>A total of 240 patients were randomised to RAPN (n = 123) or OPN (n = 117). Enrolment was stopped prematurely due to slow recruitment. After patient withdrawal post-randomisation, 117 patients underwent RAPN and 90 OPN. The primary endpoint was assessable in 112 and 89 patients, respectively. The 30-day complication rate did not differ between groups: RAPN 41/112 (37%) versus OPN 41/89 (46%) (one-sided: P = 0.088). The difference of -9.5% (95% confidence interval -23.1% to 4.2%) numerically favoured RAPN. The most frequent high-grade complications (CD III-IV) to post-operative day 30 (POD30) were urine leakage [RAPN 4/112 (4%) versus OPN 2/89 (2%)] and post-operative bleeding [2/117 (2%) versus 1/89 (1%)]. Compared with OPN, RAPN patients had longer operative and warm ischaemia times, shorter hospital stay, and reported better recovery, less opioid use, less pain, and improved quality of life (QoL) up to POD30.</p><p><strong>Conclusions: </strong>There was no statistically significant difference in the 30-day complication rate between RAPN and OPN in this underpowered trial. Few high-grade complications occurred over the whole cohort with intermediate/high-complexity tumours. Despite less intense pain management, patients undergoing RAPN reported less pain and better QoL up to POD30.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7000,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Open versus robotic-assisted partial nephrectomy in patients with intermediate/high-complexity kidney tumours: final results of the randomised, controlled, open-label, multicentre trial OpeRa.\",\"authors\":\"M-O Grimm, J Bedke, J Nyarangi-Dix, W Khoder, S Foller, H-J Sommerfeld, M Giessing, M Heck, W Meißner, A Slee, K Leucht, F von Rundstedt, G Theil, S Buse, S Siemer, P Albers, C Gratzke, M Hohenfellner, A Stenzl\",\"doi\":\"10.1016/j.annonc.2025.04.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The prospective, randomised, open-label, multicentre OpeRa trial (NCT03849820) aimed to determine whether robotic-assisted partial nephrectomy (RAPN) is superior to open partial nephrectomy (OPN) in reducing 30-day post-operative complications during the treatment of intermediate/high-complexity renal tumours.</p><p><strong>Patients and methods: </strong>Eligible patients aged ≥18 years had a renal tumour suitable for OPN or RAPN, a RENAL score ≥7, and an estimated glomerular filtration rate ≥50 ml/min/1.73 m<sup>2</sup>. Patients were randomised from 15 March 2019 to 23 November 2021 in 12 German hospitals and assigned (1 : 1) to undergo RAPN or OPN. Primary endpoint was the 30-day post-operative complication rate [Clavien-Dindo (CD) I-V] in the modified intention-to-treat population. We aimed to recruit 606 patients to detect ≥10% reduction in the primary endpoint for RAPN versus OPN.</p><p><strong>Results: </strong>A total of 240 patients were randomised to RAPN (n = 123) or OPN (n = 117). Enrolment was stopped prematurely due to slow recruitment. After patient withdrawal post-randomisation, 117 patients underwent RAPN and 90 OPN. The primary endpoint was assessable in 112 and 89 patients, respectively. The 30-day complication rate did not differ between groups: RAPN 41/112 (37%) versus OPN 41/89 (46%) (one-sided: P = 0.088). The difference of -9.5% (95% confidence interval -23.1% to 4.2%) numerically favoured RAPN. The most frequent high-grade complications (CD III-IV) to post-operative day 30 (POD30) were urine leakage [RAPN 4/112 (4%) versus OPN 2/89 (2%)] and post-operative bleeding [2/117 (2%) versus 1/89 (1%)]. Compared with OPN, RAPN patients had longer operative and warm ischaemia times, shorter hospital stay, and reported better recovery, less opioid use, less pain, and improved quality of life (QoL) up to POD30.</p><p><strong>Conclusions: </strong>There was no statistically significant difference in the 30-day complication rate between RAPN and OPN in this underpowered trial. Few high-grade complications occurred over the whole cohort with intermediate/high-complexity tumours. Despite less intense pain management, patients undergoing RAPN reported less pain and better QoL up to POD30.</p>\",\"PeriodicalId\":8000,\"journal\":{\"name\":\"Annals of Oncology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":56.7000,\"publicationDate\":\"2025-04-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.annonc.2025.04.005\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.annonc.2025.04.005","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：这项前瞻性、随机、开放标签、多中心OpeRa试验（NCT03849820）旨在确定机器人辅助部分肾切除术（RAPN）在减少中/高复杂性肾肿瘤治疗期间30天术后并发症方面是否优于开放式部分肾切除术（OPN）。患者和方法：符合条件的患者年龄≥18岁，有适合OPN或RAPN的肾肿瘤，肾评分≥7，eGFR≥50ml/min/1.73m2。患者于2019年3月15日至2021年11月23日在12家德国医院随机分组，并按1:1比例分配接受RAPN或OPN。主要终点是改良意向治疗（mITT）人群的30天术后并发症发生率（Clavien-Dindo I-V）。我们的目标是招募606名患者，以检测RAPN与OPN的主要终点降低≥10%。结果：240例患者随机分为RAPN组（n=123）和OPN组（n=117）。由于招聘缓慢，招生提前停止。随机化后患者停药后，117例患者接受RAPN， 90例患者接受OPN。主要终点分别在112例和89例患者中可评估：30天并发症发生率在两组之间没有差异：RAPN 41/112（37%）与OPN 41/89(46%)（单侧：P=0.088）。数值上，-9.5% （95% CI -23.1-4.2）的差异有利于RAPN。至术后第30天（POD30）最常见的高级并发症（Clavien-Dindo III-IV）为尿漏（RAPN 4/112 [4%] vs. OPN 2/89[2%]）和术后出血（2/117 [2%]vs. 1/89[1%]）。与OPN相比，RAPN患者有更长的手术和热缺血时间，更短的住院时间，并报告更好的恢复，更少的阿片类药物使用，更少的疼痛和改善的生活质量，直到POD30。结论：在这项低功率试验中，RAPN和OPN在30天并发症发生率方面无统计学差异。在整个中/高复杂性肿瘤队列中，很少发生高级别并发症。尽管疼痛管理强度较低，接受RAPN的患者报告疼痛减轻，生活质量提高至POD30。
Open versus robotic-assisted partial nephrectomy in patients with intermediate/high-complexity kidney tumours: final results of the randomised, controlled, open-label, multicentre trial OpeRa.
Background: The prospective, randomised, open-label, multicentre OpeRa trial (NCT03849820) aimed to determine whether robotic-assisted partial nephrectomy (RAPN) is superior to open partial nephrectomy (OPN) in reducing 30-day post-operative complications during the treatment of intermediate/high-complexity renal tumours.
Patients and methods: Eligible patients aged ≥18 years had a renal tumour suitable for OPN or RAPN, a RENAL score ≥7, and an estimated glomerular filtration rate ≥50 ml/min/1.73 m2. Patients were randomised from 15 March 2019 to 23 November 2021 in 12 German hospitals and assigned (1 : 1) to undergo RAPN or OPN. Primary endpoint was the 30-day post-operative complication rate [Clavien-Dindo (CD) I-V] in the modified intention-to-treat population. We aimed to recruit 606 patients to detect ≥10% reduction in the primary endpoint for RAPN versus OPN.
Results: A total of 240 patients were randomised to RAPN (n = 123) or OPN (n = 117). Enrolment was stopped prematurely due to slow recruitment. After patient withdrawal post-randomisation, 117 patients underwent RAPN and 90 OPN. The primary endpoint was assessable in 112 and 89 patients, respectively. The 30-day complication rate did not differ between groups: RAPN 41/112 (37%) versus OPN 41/89 (46%) (one-sided: P = 0.088). The difference of -9.5% (95% confidence interval -23.1% to 4.2%) numerically favoured RAPN. The most frequent high-grade complications (CD III-IV) to post-operative day 30 (POD30) were urine leakage [RAPN 4/112 (4%) versus OPN 2/89 (2%)] and post-operative bleeding [2/117 (2%) versus 1/89 (1%)]. Compared with OPN, RAPN patients had longer operative and warm ischaemia times, shorter hospital stay, and reported better recovery, less opioid use, less pain, and improved quality of life (QoL) up to POD30.
Conclusions: There was no statistically significant difference in the 30-day complication rate between RAPN and OPN in this underpowered trial. Few high-grade complications occurred over the whole cohort with intermediate/high-complexity tumours. Despite less intense pain management, patients undergoing RAPN reported less pain and better QoL up to POD30.
期刊介绍：
Annals of Oncology, the official journal of the European Society for Medical Oncology and the Japanese Society of Medical Oncology, offers rapid and efficient peer-reviewed publications on innovative cancer treatments and translational research in oncology and precision medicine.
The journal primarily focuses on areas such as systemic anticancer therapy, with a specific emphasis on molecular targeted agents and new immune therapies. We also welcome randomized trials, including negative results, as well as top-level guidelines. Additionally, we encourage submissions in emerging fields that are crucial to personalized medicine, such as molecular pathology, bioinformatics, modern statistics, and biotechnologies. Manuscripts related to radiotherapy, surgery, and pediatrics will be considered if they demonstrate a clear interaction with any of the aforementioned fields or if they present groundbreaking findings.
Our international editorial board comprises renowned experts who are leaders in their respective fields. Through Annals of Oncology, we strive to provide the most effective communication on the dynamic and ever-evolving global oncology landscape.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
