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/)。
{"title":"Cost analyses in randomized trials on robot-assisted surgery: systematic review.","authors":"Sterre R J Bosscha, Rawin Amiri, Faridi Jamaludin, Maroeska Rovers, Marc G Besselink, Jony van Hilst","doi":"10.1093/bjsopen/zraf161","DOIUrl":"10.1093/bjsopen/zraf161","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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/).</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/PMC12848406/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146060030","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}
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。
{"title":"Impact of centre volume on adrenalectomy outcomes: European multicentre study based on EUROCRINE® registry.","authors":"Yiğit Türk, Aykut Özkılıç, Francesco Pennestri, Marco Raffaelli, Radu Mihai, Murat Özdemir, Özer Makay","doi":"10.1093/bjsopen/zraf180","DOIUrl":"10.1093/bjsopen/zraf180","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</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/PMC12888810/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148951","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}
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.
{"title":"Impact of prehabilitation on patient-perceived quality of recovery after surgery: prospective cohort study.","authors":"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","doi":"10.1093/bjsopen/zraf156","DOIUrl":"10.1093/bjsopen/zraf156","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</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/PMC12777966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917114","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}
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.
{"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}
{"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}
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.
{"title":"Prognostic role of tumour volume and downstaging response on outcome after liver transplantation for colorectal liver metastases: retrospective study.","authors":"Håvard Bjørke Jenssen, Svein Dueland, Tor Magnus Smedman, Harald Grut, Andreas Abildgaard, Pål D Line, Trygve Syversveen","doi":"10.1093/bjsopen/zraf170","DOIUrl":"10.1093/bjsopen/zraf170","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>Dynamic tumour assessment, particularly measuring tumour volume to below 35 mL, is an important prognostic marker in LT for CRLMs.</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/PMC12822776/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146017356","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}
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/).
{"title":"Neoadjuvant FOLFOXIRI plus bevacizumab without radiotherapy for high-risk rectal cancer: multicentre phase II trial.","authors":"Takeru Matsuda, Yoshiaki Nagatani, Yohei Funakoshi, Takahiro Tsuboyama, Yasuhiko Mii, Kunihiko Kaneda, Tomohiro Tanaka, Hiroshi Hasegawa, Kimihiro Yamashita, Naomi Kiyota, Hironobu Minami, Yoshihiro Kakeji","doi":"10.1093/bjsopen/zraf163","DOIUrl":"10.1093/bjsopen/zraf163","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusions: </strong>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/).</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/PMC12884854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146140581","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}
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).
{"title":"Radical antegrade modular pancreatosplenectomy versus conventional left pancreatectomy for pancreatic cancer: study protocol for the multicentre randomized clinical RAMPS trial.","authors":"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","doi":"10.1093/bjsopen/zraf169","DOIUrl":"10.1093/bjsopen/zraf169","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Conclusion: </strong>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).</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/PMC12880186/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146130929","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}
{"title":"Endocrine and breast surgery in 2025: BJS Open highlights and editor's choices.","authors":"Samira M Sadowski","doi":"10.1093/bjsopen/zraf183","DOIUrl":"10.1093/bjsopen/zraf183","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/PMC12817068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008986","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}