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Revolutionizing Liver Transplantation: Transitioning to an Elective Procedure Through Ex Situ Normothermic Machine Perfusion - A Benefit Analysis. 肝脏移植的革命性变革:通过原位常温机器灌注过渡到选择性手术 - 效益分析。
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-07-30 DOI: 10.1097/SLA.0000000000006462
Zhihao Li, Matthias Pfister, Florian Huwyler, Waldemar Hoffmann, Mark W Tibbitt, Philipp Dutkowski, Pierre-Alain Clavien

Objective: To assess the impact of normothermic machine perfusion (NMP) on patients, medical teams, and costs by gathering global insights and exploring current limitations.

Background: NMP for ex situ liver graft perfusion is gaining increasing attention for its capability to extend graft preservation. It has the potential to transform liver transplantation (LT) from an urgent to a purely elective procedure, which could revolutionize LT logistics, reduce burden on patients and health care providers, and decrease costs.

Methods: A 31-item survey was sent to international transplant directors to gather their NMP experiences and vision. In addition, we performed a systematic review on cost-analysis in LT and assessed studies on cost-benefit in converting urgent-to-elective procedures. We compared the costs of available NMPs and conducted a sensitivity analysis of NMP's cost benefits.

Results: Of 120 transplant programs contacted, 64 (53%) responded, spanning North America (31%), Europe (42%), Asia (22%), and South America (5%). Of the total, 60% had adopted NMP, with larger centers (>100 transplants/year) in North America and Europe more likely to use it. The main NMP systems were OrganOx-metra (39%), XVIVO (36%), and TransMedics-OCS (15%). Despite NMP adoption, 41% of centers still perform >50% of LTs at nights/weekends. Centers recognized NMP's benefits, including improved work satisfaction and patient outcomes, but faced challenges like high costs and machine complexity. 16% would invest $100,000 to 500'000, 33% would invest $50,000 to 100'000, 38% would invest $10,000 to 50'000, and 14% would invest <$10,000 in NMP. These results were strengthened by a cost analysis for NMP in emergency-to-elective LT transition. Accordingly, while liver perfusions with disposables up to $10,000 resulted in overall positive net balances, this effect was lost when disposables' cost amounted to >$40,000/organ.

Conclusions: The adoption of NMP is hindered by high costs and operational complexity. Making LT elective through NMP could reduce costs and improve outcomes, but overcoming barriers requires national reimbursements and simplified, automated NMP systems for multiday preservation.

摘要通过收集全球见解和探讨当前的局限性,评估常温机器灌注(NMP)对患者、医疗团队和成本的影响:背景:用于原位肝移植灌注的常温机器灌注因其能够延长移植物保存时间而日益受到关注。它有可能将肝移植(LT)从紧急手术转变为纯粹的选择性手术,这将彻底改变LT的后勤工作,减轻患者和医护人员的负担,并降低成本:方法: 我们向国际移植主任发送了一份包含 31 个项目的调查问卷,以收集他们的 NMP 经验和愿景。此外,我们还对LT的成本分析进行了系统回顾,并评估了将紧急手术转为选择性手术的成本效益研究。我们比较了现有 NMP 的成本,并对 NMP 的成本效益进行了敏感性分析:我们联系了 120 个移植项目,其中 64 个(53%)做出了回应,这些项目分布在北美(31%)、欧洲(42%)、亚洲(22%)和南美(5%)。60%的项目采用了 NMP,北美和欧洲的大型中心(>100 例移植/年)更有可能使用 NMP。主要的 NMP 系统是 OrganOx-metra(39%)、XVIVO(36%)和 TransMedics-OCS(15%)。尽管采用了 NMP,但仍有 41% 的中心在夜间/周末进行超过 50% 的 LT。各中心认识到了 NMP 的好处,包括提高工作满意度和患者疗效,但也面临着高成本和机器复杂性等挑战。16%的中心将投资 100'000-500'000 美元,33%投资 50'000-100'000 美元,38%投资 10'000-50'000 美元,14%投资 40'000 美元/器官:结论:高成本和操作复杂性阻碍了 NMP 的采用。通过 NMP 使 LT 成为选择性手术可降低成本并改善疗效,但要克服障碍,需要国家补偿和用于多天保存的简化、自动化 NMP 系统。
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引用次数: 0
Impact of Preoperative Time Intervals for Neoadjuvant Chemoradiotherapy on Short-term Postoperative Outcomes of Esophageal Cancer Surgery: A Population-based Study Using the Dutch Upper Gastrointestinal Cancer Audit (DUCA) Data. 新辅助化放疗的术前时间间隔对食管癌手术术后短期疗效的影响:利用荷兰上消化道癌症审计 (DUCA) 数据进行的人群研究。
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-08 DOI: 10.1097/SLA.0000000000006476
Jingpu Wang, Cas de Jongh, Zhouqiao Wu, Eline M de Groot, Alexandre Challine, Sheraz R Markar, Hylke J F Brenkman, Jelle P Ruurda, Richard van Hillegersberg

Objective: To clarify the impact of the preoperative time intervals on short-term postoperative and pathologic outcomes in patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy.

Background: The impact of preoperative intervals on patients with esophageal cancer who received multimodality treatment remains unknown.

Methods: Patients (cT1-4aN0-3M0) treated with nCRT plus esophagectomy were included using the Dutch national DUCA database. Multivariate logistic regression was used to determine the effect of different time intervals upon short-term postoperative and pathologic outcomes: diagnosis-to-nCRT intervals (≤5, 5-8, and 8-12 weeks), nCRT-to-surgery intervals (5-11, 11-17, and >17 weeks) and total preoperative intervals (≤16, 16-25, and >25 weeks).

Results: Between 2010 and 2021, a total of 5052 patients were included. Compared with diagnosis-to-nCRT interval ≤5 weeks, the interval of 8 to 12 weeks was associated with a higher risk of overall complications ( P =0.049). Compared with nCRT-to-surgery interval of 5 to 11 weeks, the longer intervals (11-17 and >17 weeks) were associated with a higher risk of overall complications ( P =0.016; P <0.001) and anastomotic leakage ( P =0.004; P =0.030), but the interval >17 weeks was associated with lower risk of ypN+ ( P =0.021). The longer total preoperative intervals were not associated with the risk of 30-day mortality and complications compared with the interval ≤16 weeks, but the longer total preoperative interval (>25 weeks) was associated with higher ypT stage ( P =0.010) and lower pathologic complete response rate ( P =0.013).

Conclusions: In patients with esophageal cancer undergoing nCRT and esophagectomy, prolonged preoperative time intervals may lead to higher morbidity and disease progression, and the causal relationship requires further confirmation.

目的旨在明确术前时间间隔对接受新辅助化放疗(nCRT)后食管切除术的食管癌患者术后短期疗效和病理结果的影响:术前间隔期对接受多模式治疗的食管癌患者的影响尚不清楚:方法:利用荷兰国家 DUCA 数据库纳入了接受 nCRT+ 食管切除术治疗的患者(cT1-4aN0-3M0)。采用多变量逻辑回归确定不同时间间隔对短期术后和病理结果的影响:诊断到nCRT的时间间隔(≤5、5-8和8-12周)、nCRT到手术的时间间隔(5-11、11-17和>17周)以及术前总时间间隔(≤16、16-25和>25周):结果:2010-2021年间,共纳入5052例患者。与诊断到 nCRT 间隔≤5 周相比,8-12 周的间隔与较高的总体并发症风险相关(P=0.049)。与 nCRT 到手术间隔 5-11 周相比,间隔时间越长(11-17 周和 >17 周),总体并发症的风险越高(P-value=0.016;P-value17 周与 ypN+ 的低风险相关(P-value=0.021)。与间隔时间≤16周相比,较长的术前总间隔时间与30天死亡率和并发症风险无关,但较长的术前总间隔时间(>25周)与较高的ypT分期(P-value=0.010)和较低的pCR率(P-value=0.013)有关:结论:对于接受nCRT和食管切除术的食管癌患者,延长术前时间间隔可能会导致更高的发病率和疾病进展,其因果关系有待进一步证实。
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引用次数: 0
New Biomarkers to Define a Biological Borderline Situation for Pancreatic Adenocarcinoma: Results of an Ancillary Study of the PANACHE01-PRODIGE48 Trial. 定义胰腺腺癌生物学边界情况的新生物标记物--PANACHE01-PRODIGE48 试验的辅助研究结果
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-05 DOI: 10.1097/SLA.0000000000006468
Jean Pinson, Julie Henriques, Ludivine Beaussire, Nasrin Sarafan-Vasseur, Antonio Sa Cunha, Jean-Baptiste Bachet, Dewi Vernerey, Frederic Di Fiore, Lilian Schwarz
<p><strong>Objective: </strong>To investigate in patients treated for a resectable pancreatic ductal adenocarcinoma [pancreatic adenocarcinoma (PA)], the prognostic value of baseline carbohydrate antigen 19.9 (CA19-9) and circulating tumor DNA (ctDNA) for overall survival (OS), to improve death risk stratification, based on a planned ancillary study from PANACHE01-PRODIGE 48 trial.</p><p><strong>Background: </strong>Biological borderline situation that was first used by the MD Anderson, became a standard practice following the international consensus conference in 2016 to manage PA. Regarding the risk of systemic disease, especially in the setting of "markedly elevated" CA19-9, neoadjuvant therapy is advised to avoid unnecessary surgery, with a risk of early recurrence. To best define biological borderline situations, new biomarkers are needed.</p><p><strong>Methods: </strong>Characteristics at diagnosis and OS were compared between patients with or without ctDNA status available. OS was estimated with the Kaplan-Meier method and compared with a log-rank test. The restricted cubic spline approach was used to identify the optimal threshold for biological parameters for death risk stratification. Univariate and multivariate Cox proportional hazard models were estimated to assess the association of ctDNA status and other parameters with OS.</p><p><strong>Results: </strong>Among the 132 patients from the primary population for analysis in the PANACHE01 -PRODIGE 48 trial, 92(71%) were available for ctDNA status at diagnosis. No selection bias was identified between patients with or without ctDNA status. Fourteen patients (15%) were ctDNA+ and exhibited a higher risk for death [ P = 0.0188; hazard ratio (95% CI): 2.28 (1.12-4.63)]. In the 92 patients with ctDNA status available among the other parameters analyzed, only CA19-9 was statically associated with OS in univariate analysis. Patients with a log of CA19-9 equal or superior to 4.4 that corresponds to a CA19-9 of 80 UI/mL were identified at higher risk for death [ P = 0.0143; hazard ratio (95% CI): 2.2 (1.15-4.19)]. In multivariate analysis, CA19-19 remained independently associated with OS ( P = 0.0323). When combining the 2 biomarkers, the median OS was 19.4 [IC 95%: 3.8-not reached (NR)] months, 30.2 (IC 95%: 17.1-NR) months and NR (IC 95%: 39.3-NR) for "CA19-9 high and ctDNA+ group," "CA19-9 high or ctDNA+ group," and "CA19-9 low and ctDNA- group," respectively (log-rank P = 0.0069).</p><p><strong>Conclusions: </strong>Progress in the management of potentially operable PA remains limited, relying solely on strategies to optimize the sequence of complete treatment, based on modern multidrug chemotherapy (FOLFIRINOX, GemNabPaclitaxel) and surgical resection. The identification of risk criteria, such as the existence of systemic disease, is an important issue, currently referred to as "biological borderline disease." Few data, particularly from prospective studies, allow us to identify biomarkers
目的基于PANACHE01-PRODIGE 48试验的一项计划辅助研究,研究基线CA19-9和循环肿瘤DNA(ctDNA)对可切除胰腺导管腺癌(PA)患者总生存期(OS)的预后价值,以改善死亡风险分层:在 2016 年国际共识会议之后,MD Anderson 首次使用的生物边界情况成为管理 PA 的标准做法。考虑到全身性疾病的风险,尤其是在 CA19-9 "明显升高 "的情况下,建议进行新辅助治疗,以避免不必要的手术和早期复发的风险。为了更好地界定生物学边界情况,需要新的生物标志物:方法:比较有或没有ctDNA状态的患者的诊断特征和OS。OS 采用 Kaplan Meier 法估算,并用对数秩检验进行比较。采用限制立方样条法确定用于死亡风险分层的生物参数的最佳阈值。估算了单变量和多变量考克斯比例危险模型,以评估ctDNA状态和其他参数与OS的关系:在PANACHE01 -PRODIGE 48试验的主要分析人群132名患者中,有92人(71%)在诊断时可获得ctDNA状态。有无ctDNA状态的患者之间未发现选择偏差。14名患者(15%)为ctDNA+,死亡风险较高(P=0,0188;HR95% CI:2.28(1.12-4.63))。在 92 例可获得 ctDNA 状态的患者中,在分析的其他参数中,只有 CA19-9 在单变量分析中与 OS 有统计学相关性。CA19-9对数等于或大于4.4(相当于CA19-9为80 UI/mL)的患者死亡风险较高(P=0,0143;HR95% CI:2.2(1.15-4.19))。在多变量分析中,CA19-19 仍与 OS 独立相关(P 值=0.0323)。如果将两种生物标志物结合起来,"CA19-9高和ctDNA+组"、"CA19-9高或ctDNA+组 "和 "CA19-9低和ctDNA-组 "的中位OS分别为19.4个月(IC 95% 3.8-未达到)、30.2个月(IC 95% 17.1-NR)和未达到(IC 95% 39.3-NR)(logrank P=0,0069):讨论:潜在可手术 PA 的治疗进展仍然有限,仅依赖于基于现代多药化疗(FOLFIRINOX、GemNabPaclitaxel)和手术切除的完全治疗顺序优化策略。确定风险标准(如存在全身性疾病)是一个重要问题,目前被称为 "生物学边界疾病"。很少有数据,尤其是来自前瞻性研究的数据,能让我们确定 CA19-9 以外的生物标志物:结论:将ctDNA与CA19-9结合起来可能有助于更好地界定PA的生物学边界情况。
{"title":"New Biomarkers to Define a Biological Borderline Situation for Pancreatic Adenocarcinoma: Results of an Ancillary Study of the PANACHE01-PRODIGE48 Trial.","authors":"Jean Pinson, Julie Henriques, Ludivine Beaussire, Nasrin Sarafan-Vasseur, Antonio Sa Cunha, Jean-Baptiste Bachet, Dewi Vernerey, Frederic Di Fiore, Lilian Schwarz","doi":"10.1097/SLA.0000000000006468","DOIUrl":"10.1097/SLA.0000000000006468","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To investigate in patients treated for a resectable pancreatic ductal adenocarcinoma [pancreatic adenocarcinoma (PA)], the prognostic value of baseline carbohydrate antigen 19.9 (CA19-9) and circulating tumor DNA (ctDNA) for overall survival (OS), to improve death risk stratification, based on a planned ancillary study from PANACHE01-PRODIGE 48 trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Biological borderline situation that was first used by the MD Anderson, became a standard practice following the international consensus conference in 2016 to manage PA. Regarding the risk of systemic disease, especially in the setting of \"markedly elevated\" CA19-9, neoadjuvant therapy is advised to avoid unnecessary surgery, with a risk of early recurrence. To best define biological borderline situations, new biomarkers are needed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Characteristics at diagnosis and OS were compared between patients with or without ctDNA status available. OS was estimated with the Kaplan-Meier method and compared with a log-rank test. The restricted cubic spline approach was used to identify the optimal threshold for biological parameters for death risk stratification. Univariate and multivariate Cox proportional hazard models were estimated to assess the association of ctDNA status and other parameters with OS.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among the 132 patients from the primary population for analysis in the PANACHE01 -PRODIGE 48 trial, 92(71%) were available for ctDNA status at diagnosis. No selection bias was identified between patients with or without ctDNA status. Fourteen patients (15%) were ctDNA+ and exhibited a higher risk for death [ P = 0.0188; hazard ratio (95% CI): 2.28 (1.12-4.63)]. In the 92 patients with ctDNA status available among the other parameters analyzed, only CA19-9 was statically associated with OS in univariate analysis. Patients with a log of CA19-9 equal or superior to 4.4 that corresponds to a CA19-9 of 80 UI/mL were identified at higher risk for death [ P = 0.0143; hazard ratio (95% CI): 2.2 (1.15-4.19)]. In multivariate analysis, CA19-19 remained independently associated with OS ( P = 0.0323). When combining the 2 biomarkers, the median OS was 19.4 [IC 95%: 3.8-not reached (NR)] months, 30.2 (IC 95%: 17.1-NR) months and NR (IC 95%: 39.3-NR) for \"CA19-9 high and ctDNA+ group,\" \"CA19-9 high or ctDNA+ group,\" and \"CA19-9 low and ctDNA- group,\" respectively (log-rank P = 0.0069).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Progress in the management of potentially operable PA remains limited, relying solely on strategies to optimize the sequence of complete treatment, based on modern multidrug chemotherapy (FOLFIRINOX, GemNabPaclitaxel) and surgical resection. The identification of risk criteria, such as the existence of systemic disease, is an important issue, currently referred to as \"biological borderline disease.\" Few data, particularly from prospective studies, allow us to identify biomarkers","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":null,"pages":null},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interobserver Variability in the International Study Group for Pancreatic Surgery (ISGPS)-Defined Complications After Pancreatoduodenectomy: An International Cross-Sectional Multicenter Study. 国际胰腺外科研究小组(ISGPS)定义的胰十二指肠切除术后并发症的观察者间差异:一项国际多中心横断面研究。
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-01 DOI: 10.1097/SLA.0000000000006473
Tessa E Hendriks, Alberto Balduzzi, Susan van Dieren, J Annelie Suurmeijer, Roberto Salvia, Thomas F Stoop, Marco Del Chiaro, Sven D Mieog, Mark Nielen, Sabino Zani, Daniel Nussbaum, Thilo Hackert, Jakob R Izbicki, Ammar A Javed, D Brock Hewitt, Bas Groot Koerkamp, Roeland F de Wilde, Yi Miao, Kuirong Jiang, Kohei Nakata, Masafumi Nakamura, Jin-Young Jang, Mirang Lee, Cristina R Ferrone, Shailesh V Shrikhande, Vikram A Chaudhari, Olivier R Busch, Ajith K Siriwardena, Oliver Strobel, Jens Werner, Bert A Bonsing, Giovanni Marchegiani, Marc G Besselink

Objective: To determine the interobserver variability for complications of pancreatoduodenectomy as defined by the International Study Group for Pancreatic Surgery (ISGPS) and others.

Background: Good interobserver variability for the definitions of surgical complications is of major importance in comparing surgical outcomes between and within centers. However, data on interobserver variability for pancreatoduodenectomy-specific complications are lacking.

Methods: International cross-sectional multicenter study including 52 raters from 13 high-volume pancreatic centers in 8 countries on 3 continents. Per center, 4 experienced raters scored 30 randomly selected patients after pancreatoduodenectomy. In addition, all raters scored 6 standardized case vignettes. This variability and the "within centers" variability were calculated for 2-fold scoring (no complication/grade A vs grade B/C) and 3-fold scoring (no complication/grade A vs grade B vs grade C) of postoperative pancreatic fistula, postpancreatoduodenectomy hemorrhage, chyle leak, bile leak, and delayed gastric emptying. Interobserver variability is presented with Gwet AC-1 measure for agreement.

Results: Overall, 390 patients after pancreatoduodenectomy were included. The overall agreement rate for the standardized cases vignettes for 2-fold scoring was 68% (95% CI: 55%-81%, AC1 score: moderate agreement), and for 3-fold scoring 55% (49%-62%, AC1 score: fair agreement). The mean "within centers" agreement for 2-fold scoring was 84% (80%-87%, AC1 score; substantial agreement).

Conclusions: The interobserver variability for the ISGPS-defined complications of pancreatoduodenectomy was too high even though the "within centers" agreement was acceptable. Since these findings will decrease the quality and validity of clinical studies, ISGPS has started efforts aimed at reducing the interobserver variability.

目的确定国际胰腺外科研究小组(ISGPS)和其他机构定义的胰十二指肠切除术并发症的观察者间差异性:手术并发症定义的良好观察者间变异性对于比较中心之间和中心内部的手术结果至关重要。然而,关于胰十二指肠切除术特异性并发症的观察者间变异性的数据还很缺乏:国际横断面多中心研究,包括来自 3 大洲 8 个国家 13 个高容量胰腺中心的 52 名评分员。每个中心由 4 名经验丰富的评分员对随机抽取的 30 名胰十二指肠切除术后患者进行评分。此外,所有评分员还对 6 个标准化病例进行评分。对术后胰瘘 (POPF)、胰十二指肠切除术后出血 (PPH)、糜烂性渗漏 (CL)、胆汁渗漏 (BL) 和胃排空延迟 (DGE) 的两倍评分(无并发症/A 级 vs B/C 级)和三倍评分(无并发症/A 级 vs B 级 vs C 级)计算了这种变异性和 "中心内 "变异性。用 Gwet's AC-1 测量法显示观察者之间的一致性:结果:共纳入了 390 名胰十二指肠切除术后患者。标准化病例小节两倍评分的总体一致率为 68%(95%-CI:55%-81%,AC1 评分:中等一致),三倍评分的总体一致率为 55%(49%-62%,AC1 评分:一般一致)。两倍评分的平均 "中心内 "一致性为 84%(80%-87%,AC1 评分;基本一致):结论:尽管 "中心内 "的一致性可以接受,但ISGPS定义的胰十二指肠切除术并发症的观察者间变异性过高。由于这些发现会降低临床研究的质量和有效性,ISGPS 已开始努力降低观察者之间的变异性。
{"title":"Interobserver Variability in the International Study Group for Pancreatic Surgery (ISGPS)-Defined Complications After Pancreatoduodenectomy: An International Cross-Sectional Multicenter Study.","authors":"Tessa E Hendriks, Alberto Balduzzi, Susan van Dieren, J Annelie Suurmeijer, Roberto Salvia, Thomas F Stoop, Marco Del Chiaro, Sven D Mieog, Mark Nielen, Sabino Zani, Daniel Nussbaum, Thilo Hackert, Jakob R Izbicki, Ammar A Javed, D Brock Hewitt, Bas Groot Koerkamp, Roeland F de Wilde, Yi Miao, Kuirong Jiang, Kohei Nakata, Masafumi Nakamura, Jin-Young Jang, Mirang Lee, Cristina R Ferrone, Shailesh V Shrikhande, Vikram A Chaudhari, Olivier R Busch, Ajith K Siriwardena, Oliver Strobel, Jens Werner, Bert A Bonsing, Giovanni Marchegiani, Marc G Besselink","doi":"10.1097/SLA.0000000000006473","DOIUrl":"10.1097/SLA.0000000000006473","url":null,"abstract":"<p><strong>Objective: </strong>To determine the interobserver variability for complications of pancreatoduodenectomy as defined by the International Study Group for Pancreatic Surgery (ISGPS) and others.</p><p><strong>Background: </strong>Good interobserver variability for the definitions of surgical complications is of major importance in comparing surgical outcomes between and within centers. However, data on interobserver variability for pancreatoduodenectomy-specific complications are lacking.</p><p><strong>Methods: </strong>International cross-sectional multicenter study including 52 raters from 13 high-volume pancreatic centers in 8 countries on 3 continents. Per center, 4 experienced raters scored 30 randomly selected patients after pancreatoduodenectomy. In addition, all raters scored 6 standardized case vignettes. This variability and the \"within centers\" variability were calculated for 2-fold scoring (no complication/grade A vs grade B/C) and 3-fold scoring (no complication/grade A vs grade B vs grade C) of postoperative pancreatic fistula, postpancreatoduodenectomy hemorrhage, chyle leak, bile leak, and delayed gastric emptying. Interobserver variability is presented with Gwet AC-1 measure for agreement.</p><p><strong>Results: </strong>Overall, 390 patients after pancreatoduodenectomy were included. The overall agreement rate for the standardized cases vignettes for 2-fold scoring was 68% (95% CI: 55%-81%, AC1 score: moderate agreement), and for 3-fold scoring 55% (49%-62%, AC1 score: fair agreement). The mean \"within centers\" agreement for 2-fold scoring was 84% (80%-87%, AC1 score; substantial agreement).</p><p><strong>Conclusions: </strong>The interobserver variability for the ISGPS-defined complications of pancreatoduodenectomy was too high even though the \"within centers\" agreement was acceptable. Since these findings will decrease the quality and validity of clinical studies, ISGPS has started efforts aimed at reducing the interobserver variability.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":null,"pages":null},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141858882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimal Treatment Strategies for cT2 Staged Adenocarcinoma of the Esophagus and the Gastroesophageal Junction: A Multinational, High-volume Center Retrospective Cohort Analysis. 食管和胃食管交界处 cT2 分期腺癌的最佳治疗策略:一项跨国、高容量中心回顾性队列分析。
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-07 DOI: 10.1097/SLA.0000000000006478
Naita M Wirsik, Cezanne D Kooij, Niall Dempster, Nerma Crnovrsanin, Noel E Donlon, Eren Uzun, Kunal Bhanot, Henrik Nienhüser, Daniela Polette, Kammy Kewani, Peter Grimminger, Daniel Reim, Florian Seyfried, Hans F Fuchs, Suzanne S Gisbertz, Christoph-Thomas Germer, Jelle P Ruurda, Fredrik Klevebro, Wolfgang Schröder, Magnus Nilsson, John V Reynolds, Mark I Van Berge Henegouwen, Sheraz Markar, Richard Van Hillegersberg, Thomas Schmidt, Christiane J Bruns

Objective: To evaluate outcomes after primary surgery (PS) or neoadjuvant treatment followed by surgery (NAT/S) in cT2 staged adenocarcinomas of the esophagus (EAC) and gastroesophageal junction (GEJ), a multinational high-volume center study was undertaken.

Background: The optimal treatment approach with either NAT/S or PS for clinically staged cT2cN any or cT2N0 EAC and GEJ remains unknown due to the lack of randomized controlled trials.

Methods: A retrospective analysis of prospectively maintained databases from 10 centers was performed. Between January 2012 and August 2023, 645 patients who fulfilled inclusion criteria of GEJ Siewert type I, II, or EAC with cT2 status at diagnosis underwent PS or NAT/S with curative intent. The primary endpoint was overall survival (OS).

Results: In the cT2cN any cohort, 192 patients (29.8%) underwent PS and 453 (70.2%) underwent NAT/S. In all cT2cN0 patients (n = 333), NAT/s remained the more frequent treatment (56.2%). Patients undergoing PS were in both cT2 cohorts older ( P < 0.001) and had a higher American Society of Anesthesiologists classification ( P < 0.05). R0 resection showed no differences between NAT/S and PS in both cT2 cohorts ( P > 0.4).Median OS was 51.0 months in the PS group (95% CI: 31.6-70.4) versus 114.0 months (95% CI: 53.9-174.1) in the NAT/S group ( P = 0.003) of cT2cN any patients. For cT2cN0 patients, NAT/S was associated with longer OS ( P = 0.002) and disease-free survival ( P = 0.001). After propensity score matching of the cT2N0 patients, survival benefit for NAT/S remained ( P = 0.004). Histopathology showed that 38.1% of cT2cN any and 34.2% of cT2cN0 patients were understaged.

Conclusions: Due to the unreliable identification of cT2N0 disease, all patients should be offered a multimodal therapeutic approach.

研究目的背景:一项多国高容量中心研究旨在评估食管(EAC)和胃食管交界处(GEJ)cT2分期腺癌的初次手术(PS)或手术后新辅助治疗(NAT/S)后的疗效:背景:由于缺乏随机对照试验,对于临床分期为cT2cNany或cT2N0的食管癌和胃食管连接部腺癌,采用NAT/S或PS的最佳治疗方法仍是未知数:对10个中心的前瞻性数据库进行回顾性分析。2012年1月至2023年8月期间,645名符合GEJ Siewert I型、II型或EAC诊断时为cT2的纳入标准的患者接受了PS或NAT/S治疗。主要终点是总生存期(OS):在 cT2cNany 组别中,192 名患者(29.8%)接受了 PS 治疗,453 名患者(70.2%)接受了 NAT/S 治疗。在所有 cT2cN0 患者(333 人)中,NAT/S 仍然是更常见的治疗方法(56.2%)。接受 PS 治疗的 cT2 患者年龄均较大(P0.4)。PS 组的中位 OS 为 51.0 个月(95% CI 31.6-70.4),而 NAT/S 组的中位 OS 为 114.0 个月(95% CI 53.9-174.1)(P=0.003)。对于 cT2cN0 患者,NAT/S 与更长的 OS(P=0.002)和无病生存期(DFS)(P=0.001)相关。对 cT2N0 患者进行倾向评分匹配后,NAT/S 的生存获益仍然存在(P=0.004)。组织病理学显示,38.1%的cT2cNany和34.2%的cT2cN0患者年龄偏低:结论:由于 cT2N0 疾病的鉴定不可靠,所有患者都应接受多模式治疗。
{"title":"Optimal Treatment Strategies for cT2 Staged Adenocarcinoma of the Esophagus and the Gastroesophageal Junction: A Multinational, High-volume Center Retrospective Cohort Analysis.","authors":"Naita M Wirsik, Cezanne D Kooij, Niall Dempster, Nerma Crnovrsanin, Noel E Donlon, Eren Uzun, Kunal Bhanot, Henrik Nienhüser, Daniela Polette, Kammy Kewani, Peter Grimminger, Daniel Reim, Florian Seyfried, Hans F Fuchs, Suzanne S Gisbertz, Christoph-Thomas Germer, Jelle P Ruurda, Fredrik Klevebro, Wolfgang Schröder, Magnus Nilsson, John V Reynolds, Mark I Van Berge Henegouwen, Sheraz Markar, Richard Van Hillegersberg, Thomas Schmidt, Christiane J Bruns","doi":"10.1097/SLA.0000000000006478","DOIUrl":"10.1097/SLA.0000000000006478","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate outcomes after primary surgery (PS) or neoadjuvant treatment followed by surgery (NAT/S) in cT2 staged adenocarcinomas of the esophagus (EAC) and gastroesophageal junction (GEJ), a multinational high-volume center study was undertaken.</p><p><strong>Background: </strong>The optimal treatment approach with either NAT/S or PS for clinically staged cT2cN any or cT2N0 EAC and GEJ remains unknown due to the lack of randomized controlled trials.</p><p><strong>Methods: </strong>A retrospective analysis of prospectively maintained databases from 10 centers was performed. Between January 2012 and August 2023, 645 patients who fulfilled inclusion criteria of GEJ Siewert type I, II, or EAC with cT2 status at diagnosis underwent PS or NAT/S with curative intent. The primary endpoint was overall survival (OS).</p><p><strong>Results: </strong>In the cT2cN any cohort, 192 patients (29.8%) underwent PS and 453 (70.2%) underwent NAT/S. In all cT2cN0 patients (n = 333), NAT/s remained the more frequent treatment (56.2%). Patients undergoing PS were in both cT2 cohorts older ( P < 0.001) and had a higher American Society of Anesthesiologists classification ( P < 0.05). R0 resection showed no differences between NAT/S and PS in both cT2 cohorts ( P > 0.4).Median OS was 51.0 months in the PS group (95% CI: 31.6-70.4) versus 114.0 months (95% CI: 53.9-174.1) in the NAT/S group ( P = 0.003) of cT2cN any patients. For cT2cN0 patients, NAT/S was associated with longer OS ( P = 0.002) and disease-free survival ( P = 0.001). After propensity score matching of the cT2N0 patients, survival benefit for NAT/S remained ( P = 0.004). Histopathology showed that 38.1% of cT2cN any and 34.2% of cT2cN0 patients were understaged.</p><p><strong>Conclusions: </strong>Due to the unreliable identification of cT2N0 disease, all patients should be offered a multimodal therapeutic approach.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":null,"pages":null},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141896602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Impact of Postoperative Complications on Recovery of Health-Related Quality of Life and Functional Capacity After Pancreatectomy: Findings From a Prospective Observational Study. 术后并发症对胰腺切除术后健康相关生活质量和功能恢复的影响:一项前瞻性观察研究的结果。
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-05 DOI: 10.1097/SLA.0000000000006472
Nicolò Pecorelli, Giovanni Guarneri, Francesca Di Salvo, Alessia Vallorani, Chiara Limongi, Gianluca Corsi, Giulia Gasparini, Martina Abati, Stefano Partelli, Stefano Crippa, Massimo Falconi

Objective: To evaluate the extent to which postoperative complications impact patient health-related quality of life (HRQoL) and survival after pancreatic surgery.

Background: Pancreatectomy is frequently associated with severe postoperative morbidity, which can affect patient recovery. Few and conflicting data are available regarding the effect of post-pancreatectomy complications on patient-reported HRQoL.

Methods: This is an observational cohort study including consecutive patients enrolled in a prospective clinical trial (NCT04431076) who underwent elective pancreatectomy (2020-2022). Before surgery and on postoperative days 15, 30, 90, and 180, patients completed the PROMIS-29 profile and Duke Activity Status Index questionnaires to assess their HRQoL and functional capacity. Mean differences in HRQoL scores were obtained using multivariable linear regression adjusting for preoperative scores and confounders.

Results: Of 528 patients, 370 (70%) experienced morbidity within 90 days, and 154 (29%) had severe complications (Clavien-Dindo grade >2). Delayed gastric emptying had the greatest impact on HRQoL, showing decreased mental health up to POD90 and physical health up to POD180 compared with uncomplicated patients. An inverse relationship between complication severity grade and HRQoL was evident for most domains, with Clavien-Dindo grade 3b to 4 patients showing worse HRQoL and functional capacity scores up to 6 months after surgery. In 235 pancreatic cancer patients, grade 3b and 4 complications were associated with reduced disease-specific survival (median 25 vs 41 mo, P <0.001).

Conclusions: In patients undergoing pancreatic resection, postoperative complications significantly impact all domains of patient quality of life with a dose-effect relationship between complication severity and impairment of HRQoL and functional capacity.

目的评估术后并发症对胰腺手术后患者健康相关生活质量(HRQoL)和存活率的影响程度:胰腺切除术常伴有严重的术后发病率,这会影响患者的康复。关于胰腺切除术后并发症对患者报告的 HRQoL 的影响,现有数据很少且相互矛盾:这是一项观察性队列研究,包括连续加入前瞻性临床试验(NCT04431076)、接受择期胰腺切除术(2020-2022 年)的患者。在手术前和术后第 15、30、90、180 天 (POD),患者填写 PROMIS-29 资料和杜克活动状态指数问卷,以评估其 HRQoL 和功能能力。采用多变量线性回归法得出 HRQoL 评分的平均差异,并对术前评分和混杂因素进行调整:528名患者中,370人(70%)在90天内发病,154人(29%)出现严重并发症(克拉维恩-丁多分级>2)。与无并发症患者相比,胃排空延迟对患者的 HRQoL 影响最大,POD90 和 POD180 患者的心理健康和身体健康均有所下降。在大多数领域,并发症严重程度等级与 HRQoL 之间存在明显的反比关系,克拉维恩-丁度 3b-4 级患者在术后 6 个月内的 HRQoL 和功能能力评分较差。在235名胰腺癌患者中,3b级和4级并发症与疾病特异性生存期的降低有关(中位生存期分别为25个月和41个月):在接受胰腺切除术的患者中,术后并发症对患者生活质量的各个领域都有显著影响,并发症的严重程度与患者生活质量和功能能力的损害之间存在剂量效应关系。
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引用次数: 0
In-depth Clinical, Hemodynamic, and Volumetric Assessment of the Resection and Partial Liver Transplantation With Delayed Total Hepatectomy-Type Auxiliary Liver Transplantation in Noncirrhotic Setting: Are We Simply Dealing With a Transplant Model of Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy? 深入评估非肝硬化患者 RAPID 型辅助肝移植的临床、血流动力学和容积;我们只是在处理 ALPPS 移植模型吗?
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-07 DOI: 10.1097/SLA.0000000000006475
Laurent Coubeau, Alix Fontaine, Olga Ciccarelli, Eliano Bonaccorsi, Max Derudder, Géraldine Dahqvist, Lancelot Marique, Raymond Reding, Isabelle A Leclercq, Alexandra Dili

Background: The Resection And Partial Liver Transplantation with Delayed total hepatectomy (RAPID) procedure involves left hepatectomy with orthotopic implantation of a left lobe and right portal vein ligation. This technique induces volumetric graft increase, allowing for a right completion hepatectomy within 15 days. Notably, there is a lack of data on the hemodynamics of small-for-size grafts exposed to portal overflow without triggering small-for-size syndrome.

Methods: A prospective single-center protocol included 8 living donors and 8 RAPID noncirrhotic recipients. Comprehensive clinical and biological data were collected, accompanied by intraoperative arterial and portal flow and pressure measurements. Early kinetic growth rate (eKGR%) and graft function were assessed using computed tomography and 99Tc-mebrofenin scintigraphy on postoperative days 7 and 14. Findings were compared with retrospective data from 13 left living donor liver transplantation (LDLT) recipients.

Results: The median Graft-body weight ratio was 0.41% (interquartile range: 0.34-0.49), markedly lower than in LDLT. However, there was no significant difference in eKGR between RAPID and LDLT grafts. Sequential analysis revealed variable eKGR per day: 10.6% (7.8-13.2) in the first week and 7.6% (6-9.1) in the second week posttransplantation. Indexed portal flow (indexed portal vein flow) was significantly higher in RAPID compared with left LDLT ( P = 0.01). No hemodynamic parameters were found to correlate with regeneration speed. We modulated portal flow in 2 out of 8 cases.

Conclusions: This study presents the first report of hemodynamic and volumetric data for the RAPID technique. Despite initial graft volumes falling below conventional LDLT recommendations, the study highlights acceptable clinical outcomes.

背景:RAPID(Resection And Partial Liver Transplantation with Delayed Total Hepatectomy,延迟全肝切除和部分肝移植)手术包括左肝切除、左叶正位植入和右门静脉结扎。这种技术可诱导移植物体积增大,从而在 15 天内完成右肝切除术。值得注意的是,目前还缺乏有关小尺寸(SFS)移植物暴露于门静脉溢流而不会引发 SFS 综合征的血液动力学数据:方法:一项前瞻性单中心方案包括 8 名活体供体和 8 名 RAPID 非肝硬化受体。收集了全面的临床和生物学数据,并进行了术中动脉和门静脉血流及压力测量。术后第 7 天和第 14 天,使用 CT 和 99Tc-mebrofenin 闪烁扫描评估早期动能生长率(eKGR%)和移植物功能。研究结果与13例左侧活体肝移植(LDLT)受者的回顾性数据进行了比较:中位移植物体重比为 0.41%(IQR,0.34 至 0.49),明显低于 LDLT。然而,RAPID和LDLT移植物的eKGR没有明显差异。序列分析显示,每天的 eKGR 有所不同:移植后第一周为 10.6%(7.8-13.2),第二周为 7.6%(6-9.1)。与左侧 LDLT 相比,RAPID 的指数门脉流量(iQpv)明显更高(P=0.01)。没有发现血液动力学参数与再生速度相关。我们对 8 个病例中的 2 个进行了门脉流量调节:本研究首次报告了RAPID技术的血液动力学和体积数据。尽管最初的移植物体积低于传统 LDLT 的推荐值,但该研究强调了可接受的临床结果。
{"title":"In-depth Clinical, Hemodynamic, and Volumetric Assessment of the Resection and Partial Liver Transplantation With Delayed Total Hepatectomy-Type Auxiliary Liver Transplantation in Noncirrhotic Setting: Are We Simply Dealing With a Transplant Model of Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy?","authors":"Laurent Coubeau, Alix Fontaine, Olga Ciccarelli, Eliano Bonaccorsi, Max Derudder, Géraldine Dahqvist, Lancelot Marique, Raymond Reding, Isabelle A Leclercq, Alexandra Dili","doi":"10.1097/SLA.0000000000006475","DOIUrl":"10.1097/SLA.0000000000006475","url":null,"abstract":"<p><strong>Background: </strong>The Resection And Partial Liver Transplantation with Delayed total hepatectomy (RAPID) procedure involves left hepatectomy with orthotopic implantation of a left lobe and right portal vein ligation. This technique induces volumetric graft increase, allowing for a right completion hepatectomy within 15 days. Notably, there is a lack of data on the hemodynamics of small-for-size grafts exposed to portal overflow without triggering small-for-size syndrome.</p><p><strong>Methods: </strong>A prospective single-center protocol included 8 living donors and 8 RAPID noncirrhotic recipients. Comprehensive clinical and biological data were collected, accompanied by intraoperative arterial and portal flow and pressure measurements. Early kinetic growth rate (eKGR%) and graft function were assessed using computed tomography and 99Tc-mebrofenin scintigraphy on postoperative days 7 and 14. Findings were compared with retrospective data from 13 left living donor liver transplantation (LDLT) recipients.</p><p><strong>Results: </strong>The median Graft-body weight ratio was 0.41% (interquartile range: 0.34-0.49), markedly lower than in LDLT. However, there was no significant difference in eKGR between RAPID and LDLT grafts. Sequential analysis revealed variable eKGR per day: 10.6% (7.8-13.2) in the first week and 7.6% (6-9.1) in the second week posttransplantation. Indexed portal flow (indexed portal vein flow) was significantly higher in RAPID compared with left LDLT ( P = 0.01). No hemodynamic parameters were found to correlate with regeneration speed. We modulated portal flow in 2 out of 8 cases.</p><p><strong>Conclusions: </strong>This study presents the first report of hemodynamic and volumetric data for the RAPID technique. Despite initial graft volumes falling below conventional LDLT recommendations, the study highlights acceptable clinical outcomes.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":null,"pages":null},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141896589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evidence for the Positive Impact of Centralization in Esophageal Cancer Surgery. 食管癌手术集中化的积极影响证据。
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-13 DOI: 10.1097/SLA.0000000000006487
Noel E Donlon, Brendan Moran, Maria Davern, Matthew G Davey, Czara Kennedy, Roisin Leahy, Jenny Moore, Sinead King, Maeve Lowery, Moya Cunningham, Claire L Donohoe, Dermot O'Toole, Narayanasamy Ravi, John V Reynolds

Objective: To analyze the impact of centralization on key metrics, outcomes, and patterns of care at the Irish National Center.

Background: Overall survival rates for esophageal cancer in the West have doubled in the last 25 years. An international trend towards centralization may be relevant; however, this model remains controversial, with Ireland centralizing esophageal cancer surgery in 2011.

Methods: All patients (n=1245) with adenocarcinoma of the esophagus or junction treated with curative intent involving surgery, including endoscopic surgery, were included (n=461 from 2000 to 2011, and 784 from 2012 to 2022). All data entry was prospectively recorded. Overall survival was measured (1) for the entire cohort, (2) for patients with locally advanced disease (cT 2-3 N 0-3 ), and (3) for patients undergoing neoadjuvant therapy. All complications were recorded as per Esophageal Complication Consensus Group definitions, and the Clavien-Dindo severity classification. Data were analyzed using GraphPad Prism (v.6.0) for Windows and SPSS (v.23.0) software (SPSS) R Studio (R version 4.2.2). Survival times were calculated using a log-rank test and Cox regression analysis, and Kaplan-Meier curves were generated.

Results: Endotherapy for cT1a/intramucosal cancer adenocarcinoma increased from 40 (9% total) to 245 (31% total) procedures between the pre-centralization and post-centralization (post-C) periods. A significantly ( P < 0.001) higher proportion of patients with cT 2-3 N 0-3 disease in the post-C period underwent neoadjuvant therapy (66% vs 53%). Operative mortality was lower ( P =0.02) post-C, at 2% versus 4.5%, and ≥IIIa Clavien-Dindo major complications decreased from 33% to 25% ( P < 0.01). Recurrence rates were lower post-C (38% vs 53%, P < 0.01). Median overall survival was 73.83 versus 47.23 months in the 2012 to 2022 and 2000 to 2011 cohorts, respectively ( P < 0.001). For those who received neoadjuvant therapy, the median survival was 28.5 months pre-centralization and 42.5 months post-C ( P < 0.001).

Conclusions: These data highlight improvements in both operative outcomes and survival from the time of centralization, and a major expansion of endoscopic surgery. Although not providing proof, the study suggests a positive impact of formal centralization with governance on key quality metrics and an evolution in patterns of care.

目的在这项研究中,我们分析了集中化对爱尔兰国家中心的关键指标、结果和护理模式的影响:过去 25 年中,西方国家食管癌患者的总生存率翻了一番。集中化的国际趋势可能与此有关,但这种模式仍存在争议,爱尔兰于2011年实现了食管癌手术的集中化:研究设计:纳入所有经手术(包括内窥镜手术)治愈的食管或交界处腺癌患者(n=1245)(2000-2011年461例,2012-2022年784例)。所有数据录入均为前瞻性记录。总生存率的测量对象包括:(i) 整组患者;(ii) 局部晚期疾病(cT2-3N0-3)患者;(iii) 接受新辅助治疗的患者。所有并发症均按照食管并发症共识小组(ECCG)的定义和克拉维恩-丁多(CD)严重程度分类进行记录:数据采用 Windows 版 GraphPad Prism(v.6.0)和 SPSS(v.23.0)软件(SPSS,Chicago,IL)RStudio(Rversion4.2.2)进行分析。采用对数秩检验和 Cox 回归分析计算生存时间,并生成 Kaplan-Meier 曲线:结果:在集中化前(pre-C)和集中化后(post-C)期间,针对 cT1a/IMC 腺癌的腔内治疗从 40 例(占总数的 9%)增加到 245 例(占总数的 31%)。主要并发症从 33% 明显降低到 25%:这些数据凸显了集中化后手术效果和存活率的提高,以及内窥镜手术的大幅扩展。虽然没有提供证据,但这项研究表明,正式的集中管理对关键质量指标有积极影响,并促进了护理模式的演变。
{"title":"Evidence for the Positive Impact of Centralization in Esophageal Cancer Surgery.","authors":"Noel E Donlon, Brendan Moran, Maria Davern, Matthew G Davey, Czara Kennedy, Roisin Leahy, Jenny Moore, Sinead King, Maeve Lowery, Moya Cunningham, Claire L Donohoe, Dermot O'Toole, Narayanasamy Ravi, John V Reynolds","doi":"10.1097/SLA.0000000000006487","DOIUrl":"10.1097/SLA.0000000000006487","url":null,"abstract":"<p><strong>Objective: </strong>To analyze the impact of centralization on key metrics, outcomes, and patterns of care at the Irish National Center.</p><p><strong>Background: </strong>Overall survival rates for esophageal cancer in the West have doubled in the last 25 years. An international trend towards centralization may be relevant; however, this model remains controversial, with Ireland centralizing esophageal cancer surgery in 2011.</p><p><strong>Methods: </strong>All patients (n=1245) with adenocarcinoma of the esophagus or junction treated with curative intent involving surgery, including endoscopic surgery, were included (n=461 from 2000 to 2011, and 784 from 2012 to 2022). All data entry was prospectively recorded. Overall survival was measured (1) for the entire cohort, (2) for patients with locally advanced disease (cT 2-3 N 0-3 ), and (3) for patients undergoing neoadjuvant therapy. All complications were recorded as per Esophageal Complication Consensus Group definitions, and the Clavien-Dindo severity classification. Data were analyzed using GraphPad Prism (v.6.0) for Windows and SPSS (v.23.0) software (SPSS) R Studio (R version 4.2.2). Survival times were calculated using a log-rank test and Cox regression analysis, and Kaplan-Meier curves were generated.</p><p><strong>Results: </strong>Endotherapy for cT1a/intramucosal cancer adenocarcinoma increased from 40 (9% total) to 245 (31% total) procedures between the pre-centralization and post-centralization (post-C) periods. A significantly ( P < 0.001) higher proportion of patients with cT 2-3 N 0-3 disease in the post-C period underwent neoadjuvant therapy (66% vs 53%). Operative mortality was lower ( P =0.02) post-C, at 2% versus 4.5%, and ≥IIIa Clavien-Dindo major complications decreased from 33% to 25% ( P < 0.01). Recurrence rates were lower post-C (38% vs 53%, P < 0.01). Median overall survival was 73.83 versus 47.23 months in the 2012 to 2022 and 2000 to 2011 cohorts, respectively ( P < 0.001). For those who received neoadjuvant therapy, the median survival was 28.5 months pre-centralization and 42.5 months post-C ( P < 0.001).</p><p><strong>Conclusions: </strong>These data highlight improvements in both operative outcomes and survival from the time of centralization, and a major expansion of endoscopic surgery. Although not providing proof, the study suggests a positive impact of formal centralization with governance on key quality metrics and an evolution in patterns of care.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":null,"pages":null},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141974938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Survival and Prognostic Factors After Adrenalectomy for Secondary Malignancy: A Combined Analysis of a French University Center Registry (Eurocrine) of 307 Patients and a French Nationwide Study of 2515 Patients. 继发性恶性肿瘤肾上腺切除术后的存活率和预后因素:对法国大学中心登记的 307 例患者(Eurocrine ®)和法国全国 2,515 例患者研究的综合分析。
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-07 DOI: 10.1097/SLA.0000000000006479
Agathe Rémond, Camille Marciniak, Xavier Lenne, Vincent Chouraki, Mathilde Gobert, Gregory Baud, Laure Maillard, Damien Bouriez, Ellen Liekens, Gianluca Donatini, Claire Nominé-Criqui, Ambroise Ravenet, Nicolas Santucci, Paulina Kuczma, Nicolas Bouviez, Christophe Tresallet, Eric Mirallié, Sophie Deguelte, Laurent Brunaud, Carole Guerin, Caroline Gronnier, Jean-Christophe Lifante, Amélie Bruandet, Didier Theis, Alexis Cortot, Arnaud Scherpereel, Aghiles Hamroun, François Pattou, Robert Caiazzo

Objective: To provide a nationwide description of postoperative outcomes and analysis of prognostic factors following adrenalectomy for metastases.

Background: Adrenal glands are a common site of metastases in many malignancies. Diagnosis of adrenal metastases is on the rise, leading to an increasing number of patient candidates for surgery without consensual management.

Methods: We conducted a population-based study between January 2012 and December 2022 using the French National Health Data System (SNDS) and the Eurocrine registry (NCT03410394). The first database exhaustively covers all procedures carried out in France, while the second provides more clinical information on procedures and tumor characteristics, based on the experience of 11 specialized centers.

Results: From the SNDS, we extracted 2515 patients who underwent adrenalectomy for secondary malignancy and 307 from the Eurocrine database. The most common primary malignancies were lung cancer (n=1203, 47.8%) and renal cancer (n=555, 22.1%). One-year survival was 84.3% (n=2120). Thirty-day mortality and morbidity rates were, respectively, 1.3% (n=32) and 29.9% (n=753, including planned intensive care unit - stays). Radiotherapy within the year before adrenalectomy was significantly associated with higher 30-day major complication rates ( P =0.039). In the Eurocrine database, the proportion of laparoscopic procedures reached 85.3% without impairing resection completeness (R0: 92.9%). Factors associated with poor overall survival were the presence of extra-adrenal metastases (hazard ratio =0.64; P =0.031) and incomplete resection (≥R1; hazard ratio=0.41; P =0.015).

Conclusions: The number of patients who can receive local treatment for adrenal metastases is rising, and adrenalectomy is more often minimally invasive and has a low morbidity rate. Subsequent research should evaluate which patients would benefit from adrenal surgery.

摘要在全国范围内描述肾上腺转移瘤切除术的术后结果并分析预后因素:肾上腺是许多恶性肿瘤的常见转移部位。肾上腺转移瘤的诊断率呈上升趋势,导致越来越多的患者在未经同意的情况下接受手术治疗:我们利用法国国家健康数据系统(SNDS)和Eurocrine®登记处(NCT03410394),在2012年1月至2022年12月期间开展了一项基于人群的研究。第一个数据库详尽涵盖了在法国进行的所有手术,第二个数据库则根据11个专业中心的经验提供了更多关于手术和肿瘤特征的临床信息:我们从 SNDS 数据库中提取了 2515 例因继发性恶性肿瘤而接受肾上腺切除术的患者,并从 Eurocrine® 数据库中提取了 307 例患者。最常见的原发性恶性肿瘤是肺癌(1203人,占47.8%)和肾癌(555人,占22.1%)。一年生存率为 84.3%(人数=2,120)。30天死亡率和发病率分别为1.3%(n=32)和29.9%(n=753,包括计划入住重症监护室)。肾上腺切除术前一年内接受放疗与较高的30天主要并发症发生率显著相关(P=0.039)。在Eurocrine®数据库中,腹腔镜手术的比例达到了85.3%,且不影响切除的完整性(R0:92.9%)。肾上腺外转移(HR=0.64;P=0.031)和不完全切除(≥R1;HR=0.41;P=0.015)是总生存率较低的相关因素:可以接受肾上腺转移瘤局部治疗的患者人数正在增加,肾上腺切除术多为微创手术,发病率较低。后续研究应评估哪些患者可从肾上腺手术中获益。
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引用次数: 0
Ex-vivo Liver Resection and Autotransplantation for Liver Malignancy : A Large Volume Retrospective Clinical Study. 肝脏恶性肿瘤的体外肝脏切除和自体移植:大容量回顾性临床研究。
IF 7.5 1区 医学 Q1 SURGERY Pub Date : 2024-11-01 Epub Date: 2024-08-15 DOI: 10.1097/SLA.0000000000006505
Abudusalamu Aini, Qian Lu, Zhiyu Chen, Zhanyu Yang, Zhipeng Liu, Leida Zhang, Jiahong Dong

Objective: To assess the effectiveness of optimized ex-vivo liver resection and autotransplantation (ELRA) for treating liver malignancies.

Background: ELRA is a promising surgery for radical resection of conventionally unresectable tumors, despite the disappointing long-term prognosis during its developmental stages. A recent multicenter study reported 5-year overall and disease-free survival rates of 28% and 20.8%, respectively.

Methods: We retrospectively analyzed data of patients who underwent ELRA for advanced liver cancers between 2009 and 2022. We applied ELRA via our novel surgical indication classification system where the surgical risk with curative intent for advanced liver malignancy was controllable using the ex-vivo approach. The ELRA was optimized for determinacy, predictability, and controllability via the precision liver surgery paradigm.

Results: Thirty-seven cases with liver malignancies were enrolled. The operative time and anhepatic phase duration were 649.6±200.0 and 261.2±74.5 minutes, respectively, while the intraoperative blood loss was 1902±1192 mL. Negative resection margins were achieved in all patients, and the 90-day morbidity at Clavien-Dindo IIIa/IIIb and mortality rates were 27.0% and 24.3%. Post-ELRA 1-, 3-, and 5-year actual overall survival rates were 62.2%, 37.8%, and 35.1%, respectively, and 1-, 3-, and 5-year actual disease-free survival rates were 43.2%, 24.3%, and 18.9%, respectively.

Conclusions: Long-term outcomes of ELRA under precision liver surgery for advanced liver malignancy were favorable. Appropriate criteria for disease selection and surgical indications and optimized procedures together can improve surgical treatment and patient prognosis.

目的评估优化的体外肝脏切除和自体移植(ELRA)治疗肝脏恶性肿瘤的效果:尽管ELRA在发展阶段的长期预后令人失望,但它是一种很有前途的根治性切除传统无法切除肿瘤的手术。最近的一项多中心研究报告显示,5 年总生存率和无病生存率(OS、DFS)分别为 28% 和 20.8%:我们回顾性分析了2009年至2022年间接受ELRA治疗的晚期肝癌患者的数据。我们通过新颖的手术适应症分类系统应用ELRA,利用体外方法控制晚期肝脏恶性肿瘤治愈性手术风险。我们通过精准肝脏手术范例(PLS)对 ELRA 的确定性、可预测性和可控性进行了优化:结果:共纳入 37 例肝脏恶性肿瘤患者。手术时间和肝期持续时间分别为(649.6±200.0)分钟和(261.2±74.5)分钟,术中失血量为(1902±1192)毫升。所有患者的切除边缘均为阴性,90 天内 Clavien-Dindo IIIa/IIIb 级发病率和死亡率分别为 27.0% 和 24.3%。ELRA术后1年、3年和5年实际OS率分别为62.2%、37.8%和35.1%,1年、3年和5年实际DFS率分别为43.2%、24.3%和18.9%:在PLS下进行ELRA治疗晚期肝脏恶性肿瘤的长期疗效良好。适当的疾病选择标准、手术适应症和优化的手术方法可以改善手术治疗和患者预后。
{"title":"Ex-vivo Liver Resection and Autotransplantation for Liver Malignancy : A Large Volume Retrospective Clinical Study.","authors":"Abudusalamu Aini, Qian Lu, Zhiyu Chen, Zhanyu Yang, Zhipeng Liu, Leida Zhang, Jiahong Dong","doi":"10.1097/SLA.0000000000006505","DOIUrl":"10.1097/SLA.0000000000006505","url":null,"abstract":"<p><strong>Objective: </strong>To assess the effectiveness of optimized ex-vivo liver resection and autotransplantation (ELRA) for treating liver malignancies.</p><p><strong>Background: </strong>ELRA is a promising surgery for radical resection of conventionally unresectable tumors, despite the disappointing long-term prognosis during its developmental stages. A recent multicenter study reported 5-year overall and disease-free survival rates of 28% and 20.8%, respectively.</p><p><strong>Methods: </strong>We retrospectively analyzed data of patients who underwent ELRA for advanced liver cancers between 2009 and 2022. We applied ELRA via our novel surgical indication classification system where the surgical risk with curative intent for advanced liver malignancy was controllable using the ex-vivo approach. The ELRA was optimized for determinacy, predictability, and controllability via the precision liver surgery paradigm.</p><p><strong>Results: </strong>Thirty-seven cases with liver malignancies were enrolled. The operative time and anhepatic phase duration were 649.6±200.0 and 261.2±74.5 minutes, respectively, while the intraoperative blood loss was 1902±1192 mL. Negative resection margins were achieved in all patients, and the 90-day morbidity at Clavien-Dindo IIIa/IIIb and mortality rates were 27.0% and 24.3%. Post-ELRA 1-, 3-, and 5-year actual overall survival rates were 62.2%, 37.8%, and 35.1%, respectively, and 1-, 3-, and 5-year actual disease-free survival rates were 43.2%, 24.3%, and 18.9%, respectively.</p><p><strong>Conclusions: </strong>Long-term outcomes of ELRA under precision liver surgery for advanced liver malignancy were favorable. Appropriate criteria for disease selection and surgical indications and optimized procedures together can improve surgical treatment and patient prognosis.</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":null,"pages":null},"PeriodicalIF":7.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141981544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Annals of surgery
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