Multi-institutional study

多机构研究
  • 文章类型: Multicenter Study
    目的:先前的研究表明,低出生体重是食管闭锁的危险因素之一。然而,关于时机和治疗方法的证据仍然很少。
    方法:在2001年至2020年对出生体重≤1500g的食管闭锁婴儿进行手术的11家医院进行了多机构观察研究,收集了数据。
    结果:在分析的46例患者中,中位出生体重为1233(IQR1042-1412)g。46例中,19(41%)在8(IQR2-101)天的中位年龄进行了确定性食管吻合术。19人中有13人经历了气管食管瘘的闭合,胃造口术,或者第一次手术的食管绑扎,其次是食管吻合术。七个婴儿,包括四例<1000g,一个月后接受吻合术等待体重增加(不同2-3000克)。未接受吻合的27名婴儿中有21名(78%)在一年内死亡,包括21(78%)患有严重心脏异常和24(89%)患有严重染色体异常(18三体)。这群人中有六个幸存者,都患有18三体,接受姑息性手术治疗。
    结论:在我们的研究中,明确的食管吻合术在第一次手术或体重增加后的后期治疗中均有效。虽然有严重的异常,一些婴儿接受姑息性手术治疗,根据他们的情况考虑下一次手术。
    方法:II.
    OBJECTIVE: Previous research has shown that low birth weight is one of the risk factors for esophageal atresia. However, there remains a paucity of evidence on the timing and the treatment method.
    METHODS: Data were collected using a multi-institutional observational study in 11 hospitals that performed surgeries on esophageal atresia babies whose birth weights were ≤1500 g from 2001 to 2020.
    RESULTS: Of the 46 patients analyzed, median birth weight was 1233 (IQR 1042-1412) g. Within 46 cases, 19 (41%) underwent definitive esophageal anastomosis at the median of age in 8 (IQR 2-101) days. Thirteen out of 19 experienced either closure of tracheoesophageal fistula, gastrostomy, or esophageal banding at the first operation, followed by esophageal anastomosis. Seven infants, including four cases of <1000 g, underwent anastomosis after one month of age to wait for weight gain (variously 2-3000 g). Twenty-one out of 27 infants (78%) who did not receive anastomosis died within one year of age, including 21 (78 %) with major cardiac anomalies and 24 (89%) with severe chromosomal anomalies (trisomy 18). Six survivors in this group, all with trisomy 18, lived with palliative surgical treatments.
    CONCLUSIONS: In our study, the definitive esophageal anastomosis was effective either at the first operation or as a later treatment after gaining weight. Although having severe anomalies, some infants receive palliative surgical treatments, and the next surgery was considered depending on their condition.
    METHODS: II.
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  • 文章类型: Journal Article
    背景:在确定计划目标体积(PTV)的余量时,通常会同时考虑几何和剂量学分量。由于剂量分布是通过控制周围剂量处方和剂量递增同时集成的增强技术中的光束孔径来形成的,通过将可变剂量测定分量并入PTV余量来调整余量是不合适的;因此,几何成分应准确估计余量计算。
    目的:我们引入了一种非对称余量计算理论,该理论使用了测量(GUM)和分数内运动不确定度的表达指南。基于基准标记的肺实时肿瘤跟踪(RTTT)的边缘,肝脏,计算和胰腺癌,然后使用蒙特卡洛(MC)模拟进行评估。
    方法:共分析了48个肺的74.705、73.235和164.968组分支内和分支间位置数据,48肝,和25名胰腺癌患者,分别,在RTTT临床试验中。位置误差的第2.5百分位数和第97.5百分位数被认为是疾病部位的每个部分的代表值。在六个方向上计算了这些代表性位置误差(PD-RPE)的概率分布的基于总体的统计信息。使用拟议的公式计算了覆盖95%人口的利润率。通过使用PD-RPE的MC模拟来计算PTV中包括临床靶体积(CTV)的含量率。
    结果:对于肺,RTTT所需的边缘至多为6.2、4.6和3.9mm,肝脏,和胰腺癌,分别。MC模拟显示,使用拟议边缘的中位含量率满足肺癌和肝癌的95%和胰腺癌的93%,根据范·赫克的公式,比利润率更接近预期利率。
    结论:我们提出的基于GUM和运动概率分布(MPD)的公式准确地计算了基于基准标记的RTTT的实际边缘大小。通过MC仿真验证了这一点。
    BACKGROUND: Both geometric and dosimetric components are commonly considered when determining the margin for planning target volume (PTV). As dose distribution is shaped by controlling beam aperture in peripheral dose prescription and dose-escalated simultaneously integrated boost techniques, adjusting the margin by incorporating the variable dosimetric component into the PTV margin is inappropriate; therefore, geometric components should be accurately estimated for margin calculations.
    OBJECTIVE: We introduced an asymmetric margin-calculation theory using the guide to the expression of uncertainty in measurement (GUM) and intra-fractional motion. The margins in fiducial marker-based real-time tumor tracking (RTTT) for lung, liver, and pancreatic cancers were calculated and were then evaluated using Monte Carlo (MC) simulations.
    METHODS: A total of 74 705, 73 235, and 164 968 sets of intra- and inter-fractional positional data were analyzed for 48 lung, 48 liver, and 25 pancreatic cancer patients, respectively, in RTTT clinical trials. The 2.5th and 97.5th percentiles of the positional error were considered representative values of each fraction of the disease site. The population-based statistics of the probability distributions of these representative positional errors (PD-RPEs) were calculated in six directions. A margin covering 95% of the population was calculated using the proposed formula. The content rate in which the clinical target volume (CTV) was included in the PTV was calculated through MC simulations using the PD-RPEs.
    RESULTS: The margins required for RTTT were at most 6.2, 4.6, and 3.9 mm for lung, liver, and pancreatic cancer, respectively. MC simulations revealed that the median content rates using the proposed margins satisfied 95% for lung and liver cancers and 93% for pancreatic cancer, closer to the expected rates than the margins according to van Herk\'s formula.
    CONCLUSIONS: Our proposed formula based on the GUM and motion probability distributions (MPD) accurately calculated the practical margin size for fiducial marker-based RTTT. This was verified through MC simulations.
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  • 文章类型: Journal Article
    目的:对于位于后上段(PS)的肝细胞癌(HCC),腹腔镜肝切除术(LLR)通常被认为比位于前外侧段(AL)的HCC更困难。但对于有积累经验的选定患者可能是安全可行的。在本研究中,我们研究了LLR对位于PS中≤3cm的单结节HCC的有效性。
    方法:2010年1月至2018年12月,共有473例患者在Kyusyu肝脏外科研究组的18个机构中接受了≤3cm的单结节肝癌部分切除术。腹腔镜部分肝切除术和开腹肝切除术(OLR)对≤3cm肝癌的近期疗效,通过PS和AL的亚组分析,使用倾向得分匹配分析进行比较。此外,还比较了LLR-PS和LLR-AL的结果。
    结果:HCC≤3cm患者的原始队列包括328名LLR患者和145名OLR患者。匹配后,分析140例LLR和140例OLR患者。两组之间在失血量方面存在显着差异(中位数,55对287毫升,P<0.001),术后并发症(0.71vs8.57%,p=0.003),和术后住院时间(中位数,9vs14天,P<0.001)。PS的亚组分析结果相似。匹配后,LLR-PS和LLR-AL的短期结果没有显着差异。
    结论:腹腔镜部分切除术可能是位于PS的单发结节≤3cm的肝癌患者的首选选择。本文受版权保护。保留所有权利。
    OBJECTIVE: Laparoscopic liver resection (LLR) for hepatocellular carcinoma (HCC) located in the posterosuperior segments (PS) have generally been considered more difficult than those for HCC in anterolateral segments (AL), but may be safe and feasible for selected patients with accumulated experience. In the present study, we investigated the effectiveness of LLR for single nodular HCCs ≤3 cm located in PS.
    METHODS: In total, 473 patients who underwent partial liver resection for single nodular HCCs ≤3 cm at the 18 institutions belonging to the Kyusyu Study Group of Liver Surgery from January 2010 to December 2018 were enrolled. The short-term outcomes of laparoscopic partial liver resection and open liver resection (OLR) for HCCs ≤3 cm, with subgroup analysis of PS and AL, were compared using propensity score-matching analysis. Furthermore, results were also compared between LLR-PS and LLR-AL.
    RESULTS: The original cohort of patients with HCC ≤3 cm included 328 patients with LLR and 145 with OLR. After matching, 140 patients with LLR and 140 with OLR were analyzed. Significant differences were found between groups in terms of volume of blood loss (median, 55 vs. 287 ml, p < 0.001), postoperative complications (0.71 vs. 8.57%, p = 0.003), and postoperative hospital stay (median, 9 vs. 14 days, p < 0.001). The results of subgroup analysis of PS were similar. Short-term outcomes did not differ significantly between LLR-PS and LLR-AL after matching.
    CONCLUSIONS: Laparoscopic partial resection could be the preferred option for single nodular HCCs ≤3 cm located in PS.
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  • 文章类型: Journal Article
    在医疗保健数据库研究中识别心肌炎病例的诊断代码的有效性尚不清楚,这项研究旨在确定台湾心肌炎的编码准确性。
    我们根据台湾最大的多机构医疗保健系统进行了一项横断面研究,以确定1月1日出院时新诊断为ICD-10-CM心肌炎代码的住院患者,2017年3月31日,2022年。我们通过金标准活检或电子病历检查来确定心肌炎的诊断,并确定了心肌炎的ICD-10-CM代码的阳性预测值(PPV)和95%置信区间(CI)。
    我们纳入了498例住院患者(平均年龄:33.8岁;女性:38.8%),在出院时诊断为新的心肌炎。代码I409(30.1%)和I514(45.4%)在任何编码位置构成了大部分心肌炎诊断代码,心肌炎的总PPV为73.5%(95%CI:69.6-77.4%).然而,对于心肌炎的诊断,PPV最高(96.6%)以代码I409作为主要诊断.我们发现132例住院患者(26.5%)是假阳性心肌炎病例,由ICD-10-CM代码识别,错误分类的潜在原因包括其他炎症疾病(n=35,26.5%),预先存在心力衰竭(n=25,18.9%)和急性心肌梗死(n=16,12.1%)。
    台湾心肌炎的ICD-10-CM编码的PPV是可以接受的,但是其他一些炎症疾病和先前存在的心脏病可能被错误地编码为心肌炎。我们的结果可能为将来的二级数据库研究提供服务,作为心肌炎诊断代码有效性的基本参考。
    UNASSIGNED: The validity of the diagnosis codes to identify myocarditis cases in healthcare databases research remains unclear, and this study aimed to determine the coding accuracy of myocarditis in Taiwan.
    UNASSIGNED: We conducted a cross-sectional study based on Taiwan\'s largest multi-institutional healthcare system to identify inpatients newly diagnosed with ICD-10-CM myocarditis codes at discharge between January 1st, 2017 and March 31st, 2022. We ascertained the myocarditis diagnosis by a gold standard biopsy or by review of electronic medical records, and the positive predictive values (PPV) with 95% confidence intervals (CI) of the ICD-10-CM codes for myocarditis were determined.
    UNASSIGNED: We included a total of 498 inpatients (mean age: 33.8 years old; female: 38.8%) with new myocarditis diagnosis at discharge. Codes I409 (30.1%) and I514 (45.4%) constituted the majority of myocarditis diagnostic codes in any coding position, and the overall PPV of the myocarditis codes was 73.5% (95% CI: 69.6-77.4%). However, the highest PPV (96.6%) for myocarditis diagnosis was noted with code I409 as the primary diagnosis. We found 132 inpatients (26.5%) who were false-positive myocarditis cases, identified by the ICD-10-CM codes, and potential reasons for misclassification included other inflammation diseases (n=35, 26.5%), pre-existing heart failure (n= 25, 18.9%) and acute myocardial infarction (n=16, 12.1%).
    UNASSIGNED: The PPV of ICD-10-CM codes for myocarditis in Taiwan was acceptable, but some other inflammation diseases and pre-existing heart diseases may be falsely coded as myocarditis. Our results may serve future secondary database studies as a fundamental reference on the validity of myocarditis diagnosis codes.
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  • 文章类型: Multicenter Study
    背景:使用机载体积图像的Radiomics分析作为一种在治疗期间预测预后的方法,引起了研究的关注;但是,缺乏标准化仍然是主要问题之一。
    目的:本研究使用拟人化放射组学体模研究了影响从机载体积图像中提取的放射组学特征的可重复性的因素。此外,使用来自多个机构的不同治疗机进行了体模实验,作为外部验证,以识别可重复的放射学特征.
    方法:体模被设计为35×20×20cm,具有八种类型的异质球体(=1、2和3cm)。使用来自8个机构的15台治疗机获取机载体积图像。其中,千伏锥束计算机断层扫描(kV-CBCT)从一个机构的四个治疗机获得的图像数据被用作内部评估数据集,以探索放射学特征的可重复性。剩余的图像数据,包括kV-CBCT,兆伏CBCT(MV-CBCT),和由七个不同机构(11台治疗机)提供的大型计算机断层摄影(MV-CT),用作外部验证数据集。总共有1,302个放射学特征,包括18个一阶,75纹理,465(即,93×5)基于高斯(LoG)滤波器的拉普拉斯算子,和744(即,93×8)基于小波滤波器的特征,在球体中提取。使用内部评估数据集计算组内相关系数(ICC)以探索特征可重复性和再现性。随后,计算变异系数(COV)以验证外部机构的特征变异性。超过0.85的绝对ICC或低于5%的COV被认为指示高度可再现的特征。
    结果:对于内部评估,ICC分析显示,具有高重复性的影像组学特征的中位数百分比为95.2%。ICC分析表明,管间电流的高重现性特征的中位数百分比,重建算法,和治疗机下降了20.8%,29.2%,和33.3%,分别。对于外部验证,COV分析显示,可重复特征的中位数百分比为31.5%.共有16个功能,包括九个基于LoG滤波器和七个基于小波滤波器的特征,被指示为高度可重复的特征。灰度游程长度矩阵(GLRLM)被分类为包含最频繁的特征(N=8),其次是灰度依赖矩阵(N=7)和灰度共生矩阵(N=1)特征。
    结论:我们开发了用于kV-CBCT影像组学分析的标准体模,MV-CBCT,和MV-CT图像。有了这个幻影,我们发现,治疗机和图像重建算法的差异降低了影像组学特征的可重复性。具体来说,用于外部验证的最具重现性的特征是基于LoG或小波滤波的GLRLM特征.然而,在将发现结果应用于预后预测之前,应事先在每个机构检查已识别特征的可接受性。本文受版权保护。保留所有权利。
    BACKGROUND: Radiomics analysis using on-board volumetric images has attracted research attention as a method for predicting prognosis during treatment; however, the lack of standardization is still one of the main concerns.
    OBJECTIVE: This study investigated the factors that influence the reproducibility of radiomic features extracted from on-board volumetric images using an anthropomorphic radiomics phantom. Furthermore, a phantom experiment was conducted with different treatment machines from multiple institutions as external validation to identify reproducible radiomic features.
    METHODS: The phantom was designed to be 35 × 20 × 20 cm with eight types of heterogeneous spheres (⌀ = 1, 2, and 3 cm). On-board volumetric images were acquired using 15 treatment machines from eight institutions. Of these, kilovoltage cone-beam computed tomography (kV-CBCT) image data acquired from four treatment machines at one institution were used as an internal evaluation dataset to explore the reproducibility of radiomic features. The remaining image data, including kV-CBCT, megavoltage-CBCT (MV-CBCT), and megavoltage computed tomography (MV-CT) provided by seven different institutions (11 treatment machines), were used as an external validation dataset. A total of 1,302 radiomic features, including 18 first-order, 75 texture, 465 (i.e., 93 × 5) Laplacian of Gaussian (LoG) filter-based, and 744 (i.e., 93 × 8) wavelet filter-based features, were extracted within the spheres. The intraclass correlation coefficient (ICC) was calculated to explore feature repeatability and reproducibility using an internal evaluation dataset. Subsequently, the coefficient of variation (COV) was calculated to validate the feature variability of external institutions. An absolute ICC exceeding 0.85 or COV under 5% was considered indicative of a highly reproducible feature.
    RESULTS: For internal evaluation, ICC analysis showed that the median percentage of radiomic features with high repeatability was 95.2%. The ICC analysis indicated that the median percentages of highly reproducible features for inter-tube current, reconstruction algorithm, and treatment machine were decreased by 20.8%, 29.2%, and 33.3%, respectively. For external validation, the COV analysis showed that the median percentage of reproducible features was 31.5%. A total of 16 features, including nine LoG filter-based and seven wavelet filter-based features, were indicated as highly reproducible features. The gray-level run-length matrix (GLRLM) was classified as containing the most frequent features (N = 8), followed by the gray-level dependence matrix (N = 7) and gray-level co-occurrence matrix (N = 1) features.
    CONCLUSIONS: We developed the standard phantom for radiomics analysis of kV-CBCT, MV-CBCT, and MV-CT images. With this phantom, we revealed that the differences in the treatment machine and image reconstruction algorithm reduce the reproducibility of radiomic features from on-board volumetric images. Specifically, the most reproducible features for external validation were LoG or wavelet filter-based GLRLM features. However, the acceptability of the identified features should be examined in advance at each institution before applying the findings to prognosis prediction.
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  • 文章类型: Journal Article
    目的:肾移植与终末期肾病(ESRD)患者的生存优势相关。然而,对腹主动脉瘤腔内修复术(EVAR)后肾移植受者(RTRs)的结局知之甚少.本研究旨在研究肾移植对选择性肾下EVAR术后围手术期结局和长期生存的影响。
    方法:血管质量倡议数据库查询了2003年至2021年所有接受择期EVAR的患者。将功能正常的RTR与未诊断为ESRD(非RTR)的非肾移植受者进行比较。结果包括30天死亡率,急性肾损伤(AKI),需要肾脏替代疗法(RRT)的新肾功能衰竭,内漏,主动脉相关再干预,主要不良心脏事件和5年生存率。使用逻辑回归分析评估RTR与围手术期结局之间的关联。
    结果:在60,522名接受择期EVAR的患者中,180(0.3%)为RTR。RTR更年轻(中位数,71岁vs74.5岁;P<.001),高血压(92%vs84%;P=.004)和糖尿病(29%vs21%;P=.005)的发生率更高。RTR的术前血清肌酐中位数较高(1.3mg/dLvs1.0mg/dL;P<.001),肾小球滤过率估计值较低(eGFR;51.6mL/minvs69.4mL/min;P<.001)。AAA直径和并发髂动脉瘤的发生率没有差异。在程序上,RTR更有可能接受全身麻醉,使用的造影剂量较低(中位数,68.6mLvs94.8ml;P<.001)和更高的晶体液输注(中位数,1700mL对1500mL;P=.039),但是在开放转换的发生率上没有观察到差异,内漏,手术时间和失血。术后,RTR的AKI发生率较高(9.4%vs2.7%;P<.001),但对新RRT的需求相似(1.1%vs0.4%;P=0.15)。术后死亡率没有差异,主动脉相关再干预和MACE。在调整了潜在的混杂因素后,RTR仍然与术后AKI的几率增加相关(OR,3.33;95%CI:1.93-5.76;P<.001),但与其他术后并发症无关。亚组分析确定糖尿病(OR,4.21;95%CI:1.17-15.14;P=.02)与RTR中术后AKI的几率增加相关。在5年,总生存率相似(83.4%vs80%;log-rankP=0.235).
    结论:在接受选择性肾下静脉内静脉造影的患者中,RTRs与术后AKI几率增加独立相关,不增加需要RRT的术后肾功能衰竭,死亡率,内漏,主动脉相关再介入或MACE。此外,5年生存率相似。因此,虽然EVAR可能会在围手术期带来类似的好处和技术成功,RTR应具有积极且最大程度地优化的肾脏保护,以减轻术后AKI的风险。
    Renal transplant is associated with substantial survival advantage in patients with end-stage renal disease. However, little is known about the outcomes of renal transplant recipients (RTRs) after endovascular abdominal aortic aneurysm repair (EVAR). This study aimed to study the effect of renal transplant on perioperative outcomes and long-term survival after elective infrarenal EVAR.
    The Vascular Quality Initiative database was queried for all patients undergoing elective EVAR from 2003 to 2021. Functioning RTRs were compared with non-renal transplant recipients without a diagnosis of end-stage renal disease (non-RTRs). The outcomes included 30-day mortality, acute kidney injury (AKI), new renal failure requiring renal replacement therapy (RRT), endoleak, aortic-related reintervention, major adverse cardiac events, and 5-year survival. A logistic regression analysis was used to assess the association between RTRs and perioperative outcomes.
    Of 60,522 patients undergoing elective EVAR, 180 (0.3%) were RTRs. RTRs were younger (median, 71 years vs 74.5 years; P < .001), with higher incidence of hypertension (92% vs 84%; P = .004) and diabetes (29% vs 21%; P = .005). RTRs had higher median preoperative serum creatinine (1.3 mg/dL vs 1.0 mg/dL; P < .001) and lower estimated glomerular filtration rate (51.6 mL/min vs 69.4 mL/min; P < .001). There was no difference in the abdominal aortic aneurysm diameter and incidence of concurrent iliac aneurysms. Procedurally, RTRs were more likely to undergo general anesthesia with lower amount of contrast used (median, 68.6 mL vs 94.8 ml; P < .001) and higher crystalloid infusion (median, 1700 mL vs 1500 mL; P = .039), but no difference was observed in the incidence of open conversion, endoleak, operative time, and blood loss. Postoperatively, RTRs experienced a higher rate of AKI (9.4% vs 2.7%; P < .001), but the need for new RRT was similar (1.1% vs 0.4%; P = .15). There was no difference in the rates of postoperative mortality, aortic-related reintervention, and major adverse cardiac events. After adjustment for potential confounders, RTRs remained associated with increased odds of postoperative AKI (odds ratio, 3.33; 95% confidence interval, 1.93-5.76; P < .001) but had no association with other postoperative complications. A subgroup analysis identified that diabetes (odds ratio, 4.21; 95% confidence interval, 1.17-15.14; P = .02) is associated with increased odds of postoperative AKI among RTRs. At 5 years, the overall survival rates were similar (83.4% vs 80%; log-rank P = .235).
    Among patients undergoing elective infrarenal EVAR, RTRs were independently associated with increased odds of postoperative AKI, without increased postoperative renal failure requiring RRT, mortality, endoleak, aortic-related reintervention, or major adverse cardiac events. Furthermore, 5-year survival was similar. As such, while EVAR may confer comparable benefits and technical success perioperatively, RTRs should have aggressive and maximally optimized renal protection to mitigate the risk of postoperative AKI.
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  • 文章类型: Journal Article
    In order to investigate the optimal approach for synchronous colorectal liver metastases (sCRLM), we sought to use the \"win ratio\" (WR), a novel statistical approach, to assess the relative benefit of simultaneous versus staged surgical treatment.
    Patients who underwent hepatectomy for sCRLM between 2008 and 2020 were identified from a multi-institutional database. The WR approach was utilized to compare composite outcomes of patients undergoing simultaneous versus staged resection.
    Among 1116 patients, 642 (57.5%) presented with sCRLM; 290 (45.2%) underwent simultaneous resection, while 352 (54.8%) underwent staged resection. In assessing the composite outcome, staged resection yielded a WR of 1.59 (95%CI 1.47-1.71) over the simultaneous approach for sCRLM. The highest WR occurred among patients requiring major hepatectomy (WR = 1.93, 95%CI 1.77-2.10) compared with patients who required minor liver resection (WR = 1.55, 95%CI 1.44-1.70).
    Staged resection was superior to simultaneous resection for sCRLM based on a WR assessment.
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  • 文章类型: Journal Article
    机器人辅助直肠手术(RRS)的围手术期和短期肿瘤学结果尚不清楚。这项回顾性观察性研究纳入了台湾三家高容量机构接受RRS的直肠腺癌患者。在605名登记的患者中,301(49.75%),176(29.09%),和116(19.17%)较低,中间,和上直肠癌,分别。低位前切除术(377,62.31%)是最常见的外科手术。术中输血10例(2%)。一名患者(0.2%)将手术转换为开放性手术,10例(1.7%)患者接受了再次手术。总并发症发生率为14.5%,包括3%的吻合口漏。手术期间和术后30天内无死亡病例发生。远端切缘和环周切缘阳性率分别为21例(3.5%)和30例(5.0%),分别。I-III期直肠癌患者的5年总体生存率和无病生存率分别为91.1%和86.3%,分别。这是台湾首个多机构研究,共有来自三家大批量医院的605名患者。总体手术和肿瘤结果与其他研究中估计的结果相当或优于其他研究。因此,RRS是高容量医院直肠切除术的有效且安全的技术。
    The perioperative and short-term oncological outcomes of robotic-assisted rectal surgery (RRS) are unclear. This retrospective observational study enrolled patients with rectal adenocarcinoma undergoing RRS from three high-volume institutions in Taiwan. Of the 605 enrolled patients, 301 (49.75%), 176 (29.09%), and 116 (19.17%) had lower, middle, and upper rectal cancers, respectively. Low anterior resection (377, 62.31%) was the most frequent surgical procedure. Intraoperative blood transfusion was performed in 10 patients (2%). The surgery was converted to an open one for one patient (0.2%), and ten (1.7%) patients underwent reoperation. The overall complication rate was 14.5%, including 3% from anastomosis leakage. No deaths occurred during surgery and within 30 days postoperatively. The positive rates of distal resection margin and circumferential resection margin were observed in 21 (3.5%) and 30 (5.0%) patients, respectively. The 5-year overall and disease-free survival rates for patients with stage I-III rectal cancer were 91.1% and 86.3%, respectively. This is the first multi-institutional study in Taiwan with 605 patients from three high-volume hospitals. The overall surgical and oncological outcomes were equivalent or superior to those estimated in other studies. Hence, RRS is an effective and safe technique for rectal resection in high-volume hospitals.
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  • 文章类型: Multicenter Study
    目的:在多个机构中使用独立的端到端剂量传递质量保证测试来量化高剂量率图像引导近距离放射治疗(HDR-IGBT)的剂量传递误差。我们研究的新颖之处在于,这是世界上第一个多机构端到端剂量递送研究。
    方法:邮政审核在圆柱形丙烯酸容器中使用了聚合物凝胶剂量计,用于后装系统。使用计算机断层扫描获取图像,治疗计划,并在每个机构进行辐照。进行计划和凝胶测量之间的剂量分布比较。审查了满足绝对剂量伽马标准的像素百分比。
    结果:35个机构参与了这项研究。剂量不确定度为3.6%±2.3%(平均值±1.96σ)。覆盖因子k=2的几何不确定度为3.5mm。公差水平设置为95%的伽马通过率,一致性标准为5%(全局)/3mm,这是根据不确定性估计确定的。满足伽马标准的像素百分比为90.4%±32.2%(平均值±1.96σ)。66%(23/35)的机构通过了验证。在未通过核查的机构中,75%(9/12)在治疗计划中输入了导管尖端与索引器长度之间的偏移量,而17%(2/12)在治疗计划中输入了不正确的导管重建。
    结论:该方法应有助于全面检查HDR-IGBT剂量递送的准确性和临床研究的凭证。我们的研究结果强调了在临床实践中提供HDR-IGBT剂量时,较大的源位置误差的高风险。
    OBJECTIVE: To quantify dose delivery errors for high-dose-rate image-guided brachytherapy (HDR-IGBT) using an independent end-to-end dose delivery quality assurance test at multiple institutions. The novelty of our study is that this is the first multi-institutional end-to-end dose delivery study in the world.
    METHODS: The postal audit used a polymer gel dosimeter in a cylindrical acrylic container for the afterloading system. Image acquisition using computed tomography, treatment planning, and irradiation were performed at each institution. Dose distribution comparison between the plan and gel measurement was performed. The percentage of pixels satisfying the absolute-dose gamma criterion was reviewed.
    RESULTS: Thirty-five institutions participated in this study. The dose uncertainty was 3.6% ± 2.3% (mean ± 1.96σ). The geometric uncertainty with a coverage factor of k = 2 was 3.5 mm. The tolerance level was set to the gamma passing rate of 95% with the agreement criterion of 5% (global)/3 mm, which was determined from the uncertainty estimation. The percentage of pixels satisfying the gamma criterion was 90.4% ± 32.2% (mean ± 1.96σ). Sixty-six percent (23/35) of the institutions passed the verification. Of the institutions that failed the verification, 75% (9/12) had incorrect inputs of the offset between the catheter tip and indexer length in treatment planning and 17% (2/12) had incorrect catheter reconstruction in treatment planning.
    CONCLUSIONS: The methodology should be useful for comprehensively checking the accuracy of HDR-IGBT dose delivery and credentialing clinical studies. The results of our study highlight the high risk of large source positional errors while delivering dose for HDR-IGBT in clinical practices.
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  • 文章类型: Journal Article
    背景:以前的单中心研究表明,使用两个原发性肿瘤块进行HER2评估(双重块HER2评估)可能是一种有效且实用的方法,可以克服异质性的不利影响并获得胃癌(GC)中的HER2阳性率。这项多中心前瞻性临床试验(NCT02843412)被启动,以验证其价值和通用性。
    方法:共有来自中国8家医院的3806名初级GCs参与者被纳入研究。选择两个原发性肿瘤块,并在组织学评估后记录为块1和块2。HER2(4B5)兔单克隆抗体用于免疫组织化学(IHC)分析。
    结果:在所有患者中,双重区块评估的HER2IHC阳性(3+)率(9.4%)高于单块评估(区块1:7.8%,第2组:7.8%)(P<0.001)。与单块评估相比,双块评估将阳性率提高了约20%。同样,HER2模棱两可(2+)率在双重阻滞评估中增加(25.8%),高于单块评估(块1:20.3%,第2组:20.9%)(P<0.001)。相反,双重阻滞评估显示HER2阴性(0/1+)率(64.8%)低于单一阻滞评估(block1:71.9%,第2组:71.3%)(P<0.001)。这些发现也在个别医院得到证实。
    结论:双重阻断HER2评估可有效提高GC切除标本中HER2IHC阳性率。我们建议在GC的常规临床实践中推广双重阻断HER2评估。
    背景:ClinicalTrials.gov,NCT02843412。2016年7月1日注册-回顾性注册。
    BACKGROUND: Former single center studies indicated that HER2 assessment with two primary tumor blocks (dual block HER2 assessment) could be an efficient and practical approach to overcome the adverse impact of heterogeneity and acquire a HER2 positive rate in gastric cancer (GC). This multicenter prospective clinical trial (NCT02843412) was launched to verify its value and generality.
    METHODS: A total of 3806 participants with primary GCs have been enrolled from 8 hospitals in China. Two primary tumor blocks were selected and recorded as block 1 and block 2 after histological evaluation. An HER2 (4B5) rabbit monoclonal antibody was used for the immunohistochemistry (IHC) analysis.
    RESULTS: In total patients, HER2 IHC positive (3+) rate with dual block assessment (9.4%) was higher than that with single block assessment (block 1: 7.8%, block 2: 7.8%) (P < 0.001). Compared with single-block assessment, dual-block assessment increased the positive rate by approximate 20%. Similarly, HER2 equivocal (2+) rate was increased in dual block assessment (25.8%), which was higher than that in single block assessment (block 1: 20.3%, block 2: 20.9%) (P < 0.001). Conversely, dual block assessment demonstrated a lower HER2 negative (0/1+) rate (64.8%) than single block assessment (block1: 71.9%, block 2: 71.3%) (P < 0.001). These findings were also confirmed in individual hospitals.
    CONCLUSIONS: Dual block HER2 assessment effectively increased HER2 IHC positive rate in resected specimens of GC. We recommended dual block HER2 assessment be promoted in routine clinical practice in GC.
    BACKGROUND: ClinicalTrials.gov, NCT02843412 . Registered 1 July 2016 - Retrospectively registered.
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