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Risk of secondary appendiceal tumours after colorectal cancer surgery: nationwide Swiss registry study. 结直肠癌手术后继发阑尾肿瘤的风险:瑞士全国登记研究
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf147
Jeremy Meyer, Elin Meyer, Evelyne Fournier, Emilie Liot, Guillaume Meurette, Thibaud Koessler, Christian Toso, Justin Davies, James Wheeler, Katharina Staehelin, Elisabetta Rapiti, Frédéric Ris, Lea Wildisen
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引用次数: 0
Cost analyses in randomized trials on robot-assisted surgery: systematic review. 机器人辅助手术随机试验的成本分析:系统综述。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf161
Sterre R J Bosscha, Rawin Amiri, Faridi Jamaludin, Maroeska Rovers, Marc G Besselink, Jony van Hilst

Background: Robot-assisted surgery (RAS) is increasingly being used, yet its cost-effectiveness remains debated. Cost analyses of RAS are therefore essential but remain challenging. This systematic review evaluated the quality of cost analyses in randomized clinical trials (RCTs) comparing RAS with alternative surgical approaches.

Methods: A systematic review was performed in PubMed, EMBASE, Cochrane Library, and Web of Science from inception up to August 2025. RCTs were included if they compared RAS with other approaches and conducted a cost analysis. Risk of bias was assessed using the revised Cochrane Risk-of-Bias tool. The methodological quality and comprehensiveness of cost analyses were evaluated with the Economic Evaluation Bias Assessment Tool (ECOBIAS) and Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist, respectively. Studies were evaluated for key structural and component-specific costs of RAS.

Results: Overall, 38 RCTs involving 5832 patients were included. Most studies focused on general surgical procedures (20 RCTs, 53%), followed by urology (7), gynaecology (7), and cardiothoracic surgery (4). RAS was compared with laparoscopic surgery in 23 RCTs, open surgery in 14 RCTs, and another robotic modality in one RCT. Regarding bias, 10 RCTs (26%) were considered high risk, and 24 (63%) had some concerns. On average, RCTs met 5 of 11 ECOBIAS criteria and 14 of 28 CHEERS items. Only 15 of 38 RCTs (39%) included key structural costs of RAS, such as robot acquisition and maintenance, whereas 12 of 38 RCTs (32%) provided a component-specific cost overview. RAS was more expensive in 33 of 36 RCTs (92%).

Conclusion: Randomized trials comparing RAS with other surgical approaches rarely perform adequate cost assessments and cost-effectiveness analyses. The substantial risk of bias, methodological heterogeneity, and partial cost reporting observed underline the need for uniform economic evaluation in RCTs on RAS. Registration number: CRD42024520677 (https://www.crd.york.ac.uk/prospero/).

背景:机器人辅助手术(RAS)的应用越来越广泛,但其成本效益仍存在争议。因此,RAS的成本分析是必要的,但仍然具有挑战性。本系统综述评价了随机临床试验(rct)中比较RAS与其他手术入路的成本分析质量。方法:系统回顾PubMed、EMBASE、Cochrane Library和Web of Science自成立至2025年8月的数据库。如果将RAS与其他方法进行比较并进行成本分析,则纳入rct。使用修订后的Cochrane风险偏倚工具评估偏倚风险。分别使用经济评价偏差评估工具(ECOBIAS)和综合卫生经济评价报告标准(CHEERS)检查表对成本分析的方法质量和全面性进行评价。研究评估了RAS的关键结构和组件特定成本。结果:共纳入38项随机对照试验,涉及5832例患者。大多数研究集中在普通外科(20项随机对照试验,53%),其次是泌尿外科(7项)、妇科(7项)和心胸外科(4项)。23项随机对照试验比较了腹腔镜手术,14项随机对照试验比较了开放手术,1项随机对照试验比较了另一种机器人方式。关于偏倚,10个rct(26%)被认为是高风险,24个rct(63%)有一些担忧。平均而言,rct满足11项ECOBIAS标准中的5项和28项CHEERS中的14项。38项随机对照试验中只有15项(39%)包括了RAS的关键结构成本,如机器人的获取和维护,而38项随机对照试验中有12项(32%)提供了特定组件的成本概述。在36个随机对照试验中,有33个(92%)的RAS更昂贵。结论:比较RAS与其他手术入路的随机试验很少进行足够的成本评估和成本-效果分析。观察到的大量偏倚风险、方法异质性和部分成本报告强调了在RAS随机对照试验中进行统一经济评估的必要性。注册号:CRD42024520677 (https://www.crd.york.ac.uk/prospero/)。
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引用次数: 0
Impact of centre volume on adrenalectomy outcomes: European multicentre study based on EUROCRINE® registry. 中心容积对肾上腺切除术结果的影响:基于EUROCRINE®注册的欧洲多中心研究。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf180
Yiğit Türk, Aykut Özkılıç, Francesco Pennestri, Marco Raffaelli, Radu Mihai, Murat Özdemir, Özer Makay

Background: The relationship between surgeon volume and patient outcomes in adrenalectomy is well established in the literature and clinical guidelines. However, evidence regarding the impact of centre volume on patient outcomes remains limited. This study aimed to evaluate the effect of centre volume on patient outcomes.

Methods: This multicentre study analysed adrenalectomy procedures from the EUROCRINE® registry (2015-2024). A volume threshold was determined using receiver operating characteristic curve analysis to predict high-grade complications (Clavien-Dindo grade ≥ III). Outcomes were compared between high- and low-volume centres, and multivariable logistic regression was used to identify independent predictors of complications and death.

Results: A total of 6672 patients undergoing adrenalectomy from 99 centres across Europe were included. The optimal centre volume threshold was ≥ 36 adrenalectomies per year. Only seven centres (7%) met this threshold, accounting for 36.7% of all procedures. High-volume centres had significantly lower rates of high-grade complications (0.9 versus 2.9%; P < 0.001), conversion (2.3 versus 3.5%), and reoperation (0.7 versus 1.6%), and shorter hospital stays (median 2 versus 3 days). Multivariable analysis showed high-volume centre status to be independently protective against high-grade complications (odds ratio 0.39, 95% confidence interval 0.24 to 0.63; P < 0.001), but not postoperative mortality (odds ratio 0.69; P = 0.480). Functional benign tumours compared with malignant tumours (odds ratio 0.61, 0.39 to 0.93; P = 0.020) and minimally invasive surgery (odds ratio 0.21, 0.14 to 0.31; P < 0.001) were both associated with a significantly lower risk of high-grade complications.

Conclusion: Centre adrenalectomy volume is a key determinant of high-grade complication risk following adrenalectomy. A threshold of ≥ 36 adrenalectomies per year identifies high-performing centres. These findings support centralization of adrenal surgery to optimize outcomes and standardize care across institutions.

背景:肾上腺切除术中手术量与患者预后之间的关系在文献和临床指南中都得到了很好的证实。然而,关于中心容积对患者预后影响的证据仍然有限。本研究旨在评估中心容积对患者预后的影响。方法:这项多中心研究分析了EUROCRINE®登记(2015-2024)的肾上腺切除术手术。采用受试者工作特征曲线分析确定容量阈值,预测高级别并发症(Clavien-Dindo分级≥III)。比较高容量和低容量中心之间的结果,并使用多变量逻辑回归来确定并发症和死亡的独立预测因素。结果:来自欧洲99个中心的6672名接受肾上腺切除术的患者被纳入研究。最佳中心容积阈值为每年≥36例肾上腺切除术。只有7家中心(7%)达到了这个门槛,占所有手术的36.7%。大容量中心的高级别并发症发生率(0.9 vs 2.9%; P < 0.001)、转换率(2.3 vs 3.5%)和再手术率(0.7 vs 1.6%)显著降低,住院时间(中位数2 vs 3天)也较短。多变量分析显示,高容积中心状态可独立预防高级并发症(优势比0.39,95%可信区间0.24 ~ 0.63;P < 0.001),但不能预防术后死亡率(优势比0.69;P = 0.480)。功能性良性肿瘤与恶性肿瘤(优势比0.61,0.39 ~ 0.93,P = 0.020)和微创手术(优势比0.21,0.14 ~ 0.31,P < 0.001)相比,发生高级别并发症的风险均显著降低。结论:中央肾上腺切除术体积是决定肾上腺切除术后高级别并发症风险的关键因素。每年≥36例肾上腺切除术的阈值确定为高绩效中心。这些发现支持肾上腺手术的集中化,以优化结果和标准化各机构的护理。
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引用次数: 0
Impact of prehabilitation on patient-perceived quality of recovery after surgery: prospective cohort study. 康复对术后患者感知康复质量的影响:前瞻性队列研究。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf156
Fernando Dana, Rubèn González-Colom, Beatriz Tena, David Capitán, Dulce Momblan, Betina Campero, Laura García Lopez, Marta Ubré, Raquel Sebio-García, Adelaida Zabalegui, Graciela Martinez-Palli

Background: Multimodal prehabilitation has the potential to reduce complications, shorten hospital stays, and decrease healthcare resource utilization. However, its impact on patient-centred outcomes, such as patient reported-outcomes, has been less extensively studied. This study assessed the effect of multimodal prehabilitation on patient-perceived quality of recovery following elective surgery.

Methods: This was a prospective cohort study of patients undergoing elective gastrointestinal surgery between 1 February 2024 and 28 February 2025 who met institutional criteria for prehabilitation. Outcomes, including comparing postoperative complications, length of hospital stay, and perceived recovery, were compared between patients who completed the prehabilitation program and those who did not (control cohort). The primary outcome measure was the Quality of Recovery-15 (QoR-15) questionnaire score.

Results: In all, 188 patients were included in the study. The 94 patients who completed the prehabilitation program over a mean(standard deviation) of 4.5(1.6) weeks had fewer postoperative complications per patient than did patients in the control group (mean(standard deviation) 1.0(1.4) versus 1.4(1.4); P = 0.008). In addition, mean(standard deviation) QoR-15 scores were significantly higher in the prehabilitation than control group at baseline (129.5(15.0) versus 122.9(17.0); P = 0.003), discharge (117.2(14.0) versus 106.8(15.0); P < 0.001), and 30 days after discharge (128.2(16.0) versus 118.5(14.0); P < 0.001). At 30 days after discharge, 66% of patients in the prehabilitation group had recovered all three pre-identified essential activities, compared with 35% in the control group (P = 0.001).

Conclusions: The findings suggest that prehabilitation not only reduces postoperative morbidity and facilitates physical recovery but also enhances patients' subjective experience of recovery throughout the surgical journey, supporting its integration into routine perioperative care for digestive surgery.

背景:多模式康复具有减少并发症、缩短住院时间和降低医疗资源利用率的潜力。然而,其对以患者为中心的结果的影响,如患者报告的结果,研究较少。本研究评估了多模式康复对选择性手术后患者感知的康复质量的影响。方法:这是一项前瞻性队列研究,研究对象为2024年2月1日至2025年2月28日期间接受选择性胃肠手术的符合机构康复标准的患者。结果,包括比较术后并发症、住院时间和感觉恢复,比较完成康复计划的患者和未完成康复计划的患者(对照队列)。主要结局指标为恢复质量-15 (QoR-15)问卷得分。结果:共纳入188例患者。94名完成康复计划的患者平均(标准差)为4.5(1.6)周,每位患者的术后并发症比对照组患者少(平均(标准差)1.0(1.4)对1.4(1.4);P = 0.008)。此外,康复组的平均(标准差)QoR-15评分在基线时显著高于对照组(129.5(15.0)vs 122.9(17.0));P = 0.003),排出量(117.2(14.0)vs 106.8(15.0);P < 0.001),出院后30天(128.2(16.0)比118.5(14.0);P < 0.001)。出院后30天,66%的康复组患者恢复了所有预先确定的三项基本活动,而对照组为35% (P = 0.001)。结论:预康复不仅降低了术后发病率,促进了身体的恢复,而且在整个手术过程中增强了患者对康复的主观体验,支持其融入消化手术的常规围手术期护理。
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引用次数: 0
Application of deep learning towards automated electromyographic wave classification for neuromonitoring in thyroid and parathyroid surgery. 深度学习在甲状腺和甲状旁腺手术神经监测中肌电波自动分类中的应用。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf158
Thomas J Musholt, Petra B Musholt, Tobias Kortus

Background: Intraoperative neuromonitoring-that is, recording of electromyographic signals-is used routinely during (para)thyroid surgery. Surgeons label selected signals to document nerve identity, body side, and time point of stimulation (before or after resection), with a mislabelling rate of 20%. For the purpose of an automated error alert of mislabelled electromyographic signals, the authors developed a multitask one-dimensional convolutional neural network.

Methods: Raw intraoperative neuromonitoring data were corrected using MIONQA software. Labelled electromyographic signals were extracted and metadata (duration of surgery, timing, median electromyographic peak values of actual surgery) were added to each electromyographic wave. Between 150 and 280 extracted features were used to train, validate, and test various convolutional neural networks.

Results: Available raw data from a single centre including 1541 operations with continuous intraoperative nerve monitoring and 508 with intermittent intraoperative nerve monitoring between 2014 and 2024 were used. By repeated adjustments of the model architecture and the number of extracted features, an optimized one-dimensional convolutional neural network was designed. After multiple runs with randomized training (11 414 electromyograms) and test (4891) data, the final optimized convolutional neural network achieved a mean(standard deviation) accuracy of 95.72(0.76)% for correct identification of recurrent laryngeal, vagal, and superior laryngeal nerves; 97.68(0.72)% for correct prediction of the resected body side; and 97.61(0.89)% for correct identification of the stimulation time point (before versus after resection). The receiver operating characteristic curve for classification of the electromyographic peak signals had an excellent area under the curve of 0.993.

Conclusion: The newly developed convolutional neural network enables accurate automated classification of electromyographic peak signals, facilitating the identification and correction of mislabelled intraoperative nerve monitoring data. Such optimized data quality is essential for artificial intelligence training, enabling neuromonitoring machines to alert the surgeon in the operating theatre of mislabelling. Future studies will aim to include a wider range of clinical scenarios and external data sets, in order to further optimize the existing labelling tool and allow clinical applications.

背景:术中神经监测,即肌电图信号的记录,在甲状腺手术中是常规使用的。外科医生标记选定的信号,以记录神经身份、身体侧面和刺激时间点(切除前或切除后),错误标记率为20%。为了对错误标记的肌电信号进行自动错误警报,作者开发了一个多任务一维卷积神经网络。方法:采用MIONQA软件对术中神经监测原始数据进行校正。提取标记的肌电信号,并将元数据(手术持续时间、时间、实际手术肌电峰值中位数)添加到每个肌电波中。提取的150到280个特征用于训练、验证和测试各种卷积神经网络。结果:2014 - 2024年,单个中心的原始数据包括1541例术中连续神经监测手术和508例术中间歇神经监测手术。通过反复调整模型结构和提取特征的数量,设计出优化的一维卷积神经网络。经过随机训练(11 414张肌电图)和测试(4891张)数据的多次运行,最终优化的卷积神经网络在正确识别喉返神经、迷走神经和喉上神经方面的平均(标准差)准确率为95.72(0.76)%;97.68(0.72)%正确预测切除体侧;97.61(0.89)%正确识别刺激时间点(切除前与切除后)。用于肌电峰信号分类的受试者工作特征曲线曲线下面积为0.993。结论:新开发的卷积神经网络能够对肌电峰信号进行准确的自动分类,便于术中神经监测数据误标的识别和纠正。这种优化的数据质量对于人工智能训练至关重要,使神经监测机器能够提醒手术室的外科医生错误标记。未来的研究将包括更广泛的临床场景和外部数据集,以进一步优化现有的标签工具并允许临床应用。
{"title":"Application of deep learning towards automated electromyographic wave classification for neuromonitoring in thyroid and parathyroid surgery.","authors":"Thomas J Musholt, Petra B Musholt, Tobias Kortus","doi":"10.1093/bjsopen/zraf158","DOIUrl":"10.1093/bjsopen/zraf158","url":null,"abstract":"<p><strong>Background: </strong>Intraoperative neuromonitoring-that is, recording of electromyographic signals-is used routinely during (para)thyroid surgery. Surgeons label selected signals to document nerve identity, body side, and time point of stimulation (before or after resection), with a mislabelling rate of 20%. For the purpose of an automated error alert of mislabelled electromyographic signals, the authors developed a multitask one-dimensional convolutional neural network.</p><p><strong>Methods: </strong>Raw intraoperative neuromonitoring data were corrected using MIONQA software. Labelled electromyographic signals were extracted and metadata (duration of surgery, timing, median electromyographic peak values of actual surgery) were added to each electromyographic wave. Between 150 and 280 extracted features were used to train, validate, and test various convolutional neural networks.</p><p><strong>Results: </strong>Available raw data from a single centre including 1541 operations with continuous intraoperative nerve monitoring and 508 with intermittent intraoperative nerve monitoring between 2014 and 2024 were used. By repeated adjustments of the model architecture and the number of extracted features, an optimized one-dimensional convolutional neural network was designed. After multiple runs with randomized training (11 414 electromyograms) and test (4891) data, the final optimized convolutional neural network achieved a mean(standard deviation) accuracy of 95.72(0.76)% for correct identification of recurrent laryngeal, vagal, and superior laryngeal nerves; 97.68(0.72)% for correct prediction of the resected body side; and 97.61(0.89)% for correct identification of the stimulation time point (before versus after resection). The receiver operating characteristic curve for classification of the electromyographic peak signals had an excellent area under the curve of 0.993.</p><p><strong>Conclusion: </strong>The newly developed convolutional neural network enables accurate automated classification of electromyographic peak signals, facilitating the identification and correction of mislabelled intraoperative nerve monitoring data. Such optimized data quality is essential for artificial intelligence training, enabling neuromonitoring machines to alert the surgeon in the operating theatre of mislabelling. Future studies will aim to include a wider range of clinical scenarios and external data sets, in order to further optimize the existing labelling tool and allow clinical applications.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"10 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12781199/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145932004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction to: Preoperative use of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers and diuretics increases the risk of dehydration after ileostomy formation: population-based cohort study. 修正:术前使用血管紧张素转换酶抑制剂、血管紧张素受体阻滞剂和利尿剂会增加回肠造口术后脱水的风险:基于人群的队列研究。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf174
{"title":"Correction to: Preoperative use of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers and diuretics increases the risk of dehydration after ileostomy formation: population-based cohort study.","authors":"","doi":"10.1093/bjsopen/zraf174","DOIUrl":"10.1093/bjsopen/zraf174","url":null,"abstract":"","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"10 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12961575/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147353926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prognostic role of tumour volume and downstaging response on outcome after liver transplantation for colorectal liver metastases: retrospective study. 肿瘤体积和降期反应对结直肠肝转移患者肝移植预后的影响:回顾性研究。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf170
Håvard Bjørke Jenssen, Svein Dueland, Tor Magnus Smedman, Harald Grut, Andreas Abildgaard, Pål D Line, Trygve Syversveen

Background: The incidence of colorectal cancer is increasing, and the liver remains the predominant site for metastases. Whereas liver resection is the standard treatment for colorectal liver metastases (CRLMs), liver transplantation (LT) has re-emerged as a viable option for selected patients. The aim of this study was to investigate whether tumour volume and changes in tumour volume during chemotherapy before transplantation predict overall survival.

Methods: Patients who underwent LT for CRLMs between November 2006 and August 2020 were included. Tumour volumes were measured via manual segmentation on computerized tomography scans at baseline, at maximum tumour volume, and immediately before LT. Response to chemotherapy was assessed using Response Evaluation Criteria in Solid Tumours (RECIST) criteria, and the heterogeneous response was noted to investigate whether this subgroup performs differently. Receiver operating characteristic analysis was conducted to determine a tumour volume cut-off value for predicting overall survival. Overall survival between groups was compared using Kaplan-Meier curves and log rank test.

Results: Fifty-nine patients who underwent LT for CRLMs were analysed retrospectively. Receiver operating characteristic analysis revealed that final tumour volume at time of LT was a strong predictor of 5-year overall survival (area under the curve= 0.789), with a 35 mL cut-off providing optimal clinical discrimination. Patients achieving a final tumour volume below 35 mL, either consistently or via downstaging, demonstrated significantly improved survival compared with those with persistently high tumour volumes (4.54 years versus 2.17 years; P < 0.001). Heterogeneous responses to chemotherapy were associated with poorer prognosis with no patients surviving beyond 2.16 years (P < 0.001).

Conclusion: Dynamic tumour assessment, particularly measuring tumour volume to below 35 mL, is an important prognostic marker in LT for CRLMs.

背景:结直肠癌的发病率正在增加,肝脏仍然是转移的主要部位。肝切除术是结肠直肠癌肝转移(crlm)的标准治疗方法,而肝移植(LT)已重新成为特定患者的可行选择。本研究的目的是研究肿瘤体积和移植前化疗期间肿瘤体积的变化是否能预测总生存。方法:纳入2006年11月至2020年8月期间接受肾移植治疗的crlm患者。在基线、最大肿瘤体积和lt前,通过计算机断层扫描的人工分割测量肿瘤体积。使用实体肿瘤反应评估标准(RECIST)标准评估化疗反应,并注意异质性反应以调查该亚组的表现是否不同。进行了接受者工作特征分析,以确定预测总生存的肿瘤体积临界值。采用Kaplan-Meier曲线和log rank检验比较组间总生存率。结果:回顾性分析59例crlm行肝移植的患者。接受者工作特征分析显示,LT时的最终肿瘤体积是5年总生存率的一个强有力的预测指标(曲线下面积= 0.789),35 mL的截止值提供了最佳的临床区分。最终肿瘤体积低于35 mL的患者,无论是持续的还是通过降分期,与肿瘤体积持续高的患者相比,生存率显著提高(4.54年对2.17年;P < 0.001)。化疗的异质性反应与较差的预后相关,没有患者存活超过2.16年(P < 0.001)。结论:动态肿瘤评估,特别是测量肿瘤体积至35ml以下,是crlm肝移植的重要预后指标。
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引用次数: 0
Neoadjuvant FOLFOXIRI plus bevacizumab without radiotherapy for high-risk rectal cancer: multicentre phase II trial. 新辅助FOLFOXIRI +贝伐单抗无放疗治疗高危直肠癌:多中心II期试验
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf163
Takeru Matsuda, Yoshiaki Nagatani, Yohei Funakoshi, Takahiro Tsuboyama, Yasuhiko Mii, Kunihiko Kaneda, Tomohiro Tanaka, Hiroshi Hasegawa, Kimihiro Yamashita, Naomi Kiyota, Hironobu Minami, Yoshihiro Kakeji

Background: The optimal neoadjuvant strategy for high-risk locally advanced rectal cancer (LARC) remains a matter of debate. This study evaluated the efficacy and safety of neoadjuvant FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, irinotecan) plus bevacizumab without radiotherapy in patients with magnetic resonance imaging-defined high-risk LARC.

Methods: A prospective, multicentre, single arm phase II trial was conducted in four Japanese Institutions between 2018 and 2024, enrolling patients with rectal adenocarcinoma and at least one high-risk criterion: clinical T4, lateral pelvic lymph node metastasis, mesorectal fascia involvement, or positive extramural vascular invasion. Patients received four cycles of FOLFOXIRI plus bevacizumab, followed by two cycles of FOLFOXIRI alone, before total mesorectal excision. The primary endpoint was pathological complete response (pCR); secondary endpoints included the R0 resection rate, local recurrence (LR), recurrence-free survival (RFS), overall survival (OS), and safety.

Results: OF 50 eligible patients, 31 were enrolled before early trial closure due to a slow accrual (accrual rate 62%). All patients underwent surgery. The pCR rate was 10% (3 of 31) and R0 resection was achieved in 97% (30 of 31) of patients. The median follow-up was 36.7 months. The 3-year cumulative LR rate was 3%, with 3-year RFS and OS rates of 73 and 81%, respectively. Grade ≥ 3 neutropenia occurred in 29% of patients, with acceptable toxicity overall. No cases of gastrointestinal perforation were observed. Grade ≥ III postoperative complications occurred in seven patients (23%), with the most frequent events being anastomotic leakage in two patients (7%).

Conclusions: In this phase II trial, although recruitment was suboptimal, neoadjuvant FOLFOXIRI plus bevacizumab achieved good local control without radiotherapy in patients with high-risk LARC. Although the pCR rate was modest compared with radiotherapy-based regimens, this chemotherapy-only approach may represent a reasonable option for select patients who are not suitable candidates for pelvic radiotherapy. Registration number: UMIN000037367 (https://www.umin.ac.jp/english/).

背景:高危局部晚期直肠癌(LARC)的最佳新辅助治疗策略仍存在争议。本研究评估了新辅助FOLFOXIRI(氟尿嘧啶、亚叶酸钙、奥沙利铂、伊立替康)加贝伐单抗治疗磁共振成像定义的高危LARC患者的有效性和安全性。方法:一项前瞻性、多中心、单臂II期临床试验于2018年至2024年在日本四家机构进行,纳入了至少一项高风险标准的直肠腺癌患者:临床T4、盆腔外侧淋巴结转移、直肠系膜筋膜受累或阳性外血管侵犯。患者接受FOLFOXIRI联合贝伐单抗治疗4个周期,随后单独使用FOLFOXIRI治疗2个周期,然后进行全肠系膜切除。主要终点为病理完全缓解(pCR);次要终点包括R0切除率、局部复发率(LR)、无复发生存期(RFS)、总生存期(OS)和安全性。结果:在50例符合条件的患者中,31例由于累积缓慢(累积率62%)而在早期试验结束前入组。所有患者均接受手术治疗。pCR率为10%(31例中有3例),97%(31例中有30例)患者实现了R0切除。中位随访时间为36.7个月。3年累计LR率为3%,3年RFS和OS率分别为73%和81%。29%的患者出现≥3级中性粒细胞减少症,总体毒性可接受。无胃肠道穿孔病例。术后出现≥III级并发症7例(23%),其中吻合口漏发生率最高2例(7%)。结论:在这项II期试验中,虽然招募情况不理想,但新辅助FOLFOXIRI +贝伐单抗在高危LARC患者中获得了良好的局部控制,无需放疗。虽然与基于放疗的方案相比,pCR率适中,但对于不适合盆腔放疗的患者,这种仅化疗的方法可能是一种合理的选择。注册号:UMIN000037367 (https://www.umin.ac.jp/english/)。
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引用次数: 0
Radical antegrade modular pancreatosplenectomy versus conventional left pancreatectomy for pancreatic cancer: study protocol for the multicentre randomized clinical RAMPS trial. 胰腺癌根治性顺行模块化胰脾切除术与传统左胰切除术:多中心随机临床RAMPS试验的研究方案
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf169
Magdalena Holze, Frank Pianka, Martin Wittmann, Ines Photiadis, Solveig Tenckhoff, Anja Sander, Alexandra Balzer, Christina Klose, Rosa Klotz, Mohammed Al-Saeedi, Martin Loos, Christoph W Michalski, Thilo Hackert, Patrick Heger, Markus K Diener, Markus W Büchler, Felix J Hüttner

Background: Complete surgical resection (R0 resection) is crucial for overall and disease-free survival in patients with pancreatic cancer undergoing curative surgery. The radical antegrade modular pancreatosplenectomy (RAMPS) procedure was developed to increase achievement of R0 resection margins for tumour resections of the pancreatic body and tail. By extending the posterior dissection plane, a more radical surgical resection can be achieved, as this is the most frequent site of positive margins in conventional left pancreatectomy. RAMPS includes a standardized lymph node dissection and early control of the splenic vessels. Feasibility and safety have already been demonstrated and retrospective studies have shown promising results regarding higher proportions of R0 resection and lymph node counts. To date, high-quality evidence from randomized clinical trials investigating the oncological benefit of RAMPS (that is, resection margin status, disease-free and overall survival) for this patient cohort is lacking.

Methods: The RAMPS trial is a multicentre, randomized clinical, patient and assessor-blinded, confirmatory, superiority trial. In all, 122 patients with an indication for left pancreatectomy due to malignancy of the pancreatic body or tail will be required in each study arm to achieve 80% power at a significance level of 0.025; patients will be randomized to either the RAMPS approach or conventional left pancreatectomy in a 1 : 1 ratio. Patients will be recruited over a 30-month enrolment period. The primary outcome will be the achievement of R0 resections. Secondary outcomes include survival and surgical, functional, and patient-reported outcomes with a 3-year follow-up.

Conclusion: The primary objective of the RAMPS trial is to demonstrate the superiority of the RAMPS approach over standard left pancreatectomy in improving the achievement of R0 resection and, consequently, long-term oncological patient outcomes. RAMPS could be established as the new surgical standard for tumour resection in patients with pancreatic cancer in the body or tail of the pancreas. Registration number: DRKS00033031 (https://www.bfarm.de/EN/BfArM/Tasks/German-Clinical-Trials-Register/_node.html).

背景:在接受根治性手术的胰腺癌患者中,完全手术切除(R0切除术)对于总生存率和无病生存率至关重要。根治性顺行模块化胰脾切除术(RAMPS)是为了提高胰腺体和尾部肿瘤切除的R0切除边缘的实现而开发的。通过扩大后剥离平面,可以实现更彻底的手术切除,因为这是传统左胰腺切除术中最常见的阳性边缘部位。RAMPS包括标准化的淋巴结清扫和脾血管的早期控制。可行性和安全性已经得到证实,回顾性研究显示,在R0切除比例和淋巴结计数方面,有希望的结果。迄今为止,研究RAMPS对该患者群体的肿瘤学益处(即切除边缘状态、无病和总生存期)的随机临床试验缺乏高质量证据。方法:RAMPS试验是一项多中心、随机临床、患者和评估者双盲、验证性、优势试验。总的来说,每个研究组需要122例因胰腺体或胰腺尾部恶性肿瘤而有左胰腺切除术指征的患者才能在显著性水平为0.025时达到80%的疗效;患者将按1:1的比例随机选择RAMPS方法或传统左胰腺切除术。患者的招募期为30个月。主要结果将是实现R0切除。次要结局包括生存、手术、功能和患者报告的3年随访结果。结论:RAMPS试验的主要目的是证明RAMPS入路比标准左胰切除术在提高R0切除术的实现和长期肿瘤患者预后方面的优势。RAMPS可作为胰腺癌体部或胰腺尾部肿瘤切除的新手术标准。注册号:DRKS00033031 (https://www.bfarm.de/EN/BfArM/Tasks/German-Clinical-Trials-Register/_node.html)。
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引用次数: 0
Endocrine and breast surgery in 2025: BJS Open highlights and editor's choices. 2025年内分泌与乳房外科:BJS公开赛亮点与编辑之选。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-12-29 DOI: 10.1093/bjsopen/zraf183
Samira M Sadowski
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引用次数: 0
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