~(18)F-FDG PET融合CT对胸中段食管鳞癌区域淋巴结分期的前瞻性研究

目的探讨正电子发射型电子计算机断层(PET)显像在胸中段食管鳞癌患者术前区域淋巴结临床分期中的应用价值。方法30例行现代二野淋巴结清扫术的胸中段食管鳞癌患者,术前进行全身~(18)F-氟代脱氧葡萄糖(~(18)F-FDG)PET融合CT显像与CT显像,对区域淋巴结检查结果进行对照研究。结果现代二野淋巴结清扫术后发现24例患者区域淋巴结阳性(80．00%),转移区域淋巴结总数为61枚。~(18)F-FDG PET融合CT发现食管区域淋巴结转移16例,敏感性、特异性和Youden指数分别为66．67%、100．0%和0．67。CT检出8例。61枚转移区域淋巴结中~(18)F-FDG PET融合CT定性43枚(70．49%),定量分析发现转移区域淋巴结计算标准化摄取值(SUV)为2．9±1．2,均＞2．5；CT检出区域淋巴结转移数24枚(39．34%)。~(18)F-FDG PET融合CT在区域淋巴结转移患者与区域淋巴结转移数均明显优于CT,P＜0．05。结论~(18)F-FDG PET融合CT在诊断胸中段食管鳞癌区域淋巴结转移方面可能优于CT。     

非小细胞肺癌纵膈淋巴结影像学分期的研究

目的：评估常见影像学检查对NSCLC纵膈淋巴结分期的准确性及价值。方法：56例经手术和病理检查确诊的NSCLC,术前患经胸部CT扫描、全身^18F—FDG PET显像和经食管超声检查,并对手术病理结果进行回颐性的分析：结果：所有56例NSCLC患肺部及相应转移部位^18F-FDG摄取增高,PET检查对预测NSCLC纵膈淋巴结转移的灵敏度为84％,特异性为90％,CT扫描纵膈淋巴结转移的灵敏度为57％,特异性为82％,其中38例行经食管超声解剖显像纵膈淋巴结转移的灵敏度为76％,特异性为70％.PET对NSCLC纵膈淋巴结转移的预测优于胸部CT解剖显像和经食管超声解剖显像。结论：应用^18F—FDG PET在对NSCLC的术前分期明显优于CT和经食管超声等常规检查,但PET在精确定位方面仍然需要结合解剖显像检查,PET—CT等图像融合技术等是今后发展的方向。     

胸中段食管鳞癌淋巴结转移度及合理清扫范围的临床研究

目的:本研究通过分析胸中段食管鳞癌淋巴结转移规律及淋巴结转移度对预后的影响,探讨合理的淋巴结清扫范围.方法:对129例经现代二野淋巴结清扫术的胸中段食管鳞癌患者的临床资料进行回顾性分析.结果:全组患者淋巴结转移率为56.6%,总淋巴结转移度(阳性淋巴结数/清扫淋巴结总数,LMR)为11.3%,上纵隔淋巴结转移率为43.4%.最常见的淋巴结受累区域为食管旁、右喉返神经旁、贲门及胃左血管旁、隆突下.影响淋巴结转移的主要因素为肿瘤浸润深度、分化程度及肿瘤长度.无淋巴结转移组、淋巴结转移度≤20%组和淋巴结转移度>20%组患者5年生存率分别为50.4%、31.0%和6.8%,结果差异有统计学意义(P=0.000).结论:淋巴结转移度是判断食管癌预后的一个重要因素,胸中段食管癌应该常规行包括双侧上纵隔的现代二野淋巴结清扫术.     

18F-FDG PET显像在食管癌诊断中的临床意义

目的探讨正电子发射型电子计算机断层(positron emission computed tomography,PET)显像在食管癌早期诊断以及临床分期中的临床应用价值.方法23例食管癌患者,进行全身18F-脱氧葡萄糖(18F-fluoro-deoxy-glucose,18F-FDG ) PET显像,并与外科手术或内镜活检病理结果和CT检查结果对照.结果46例患者中PET显像食管部位均有异常放射性浓聚灶,经病理确诊,46处食管浓聚灶均为食管癌原发病灶.其中28例为单发病灶,2例为食管多发灶,其余16例除食管原发病灶外,还有其他部位32个病灶,经临床和病理证实为远处转移病灶.与46例PET显像前CT结果相比较,PET共检出食管部位恶性病灶46例,检出率为100.0%,而CT仅检出34例,检出率为73.9%.46例中确诊有其他部位转移者18例,PET检出18例,检出率为100.0%,而PET显像前CT仅检出6例,检出率为33.3%.27例手术治疗者PET分期与临床病理分期一致,而常规检查对食管癌临床分期高估5例,低估12例,PET显像改变了这17例患者的临床治疗方案.结论18F-FDG PET显像对食管癌的诊断、淋巴结和远处转移的分期、治疗方案的制定有重要的临床应用价值.     

18F-FDG PET/CT显像在胃癌诊断中的应用

[目的]评价18F-FDG PET/CT显像在胃癌诊断中的应用.[方法]49例经胃镜和病理确诊的胃癌患者进行18F-FDG PET/CT显像,其诊断结果与病理学检查、其他影像学检查及临床随访比较.[结果] 49例患者18F-FDG PET/CT阳性44例,阳性率89.8％;39例有淋巴结转移患者中18F-FDGPET/CT显像发现32例,灵敏度为82.1％(32/39); 12例有远处转移患者中18F-FDG PET/CT显像发现11例,灵敏度91.6％(11/12).[结论]18F-FDG PET/CT显像对胃癌原发灶、淋巴结转移和远处转移具有较高的灵敏度,18F-FDG PET/CT显像在胃癌诊断中具有较高的临床价值.     

胸中下段食管鳞癌隆突下淋巴结转移CT扫描特征与病理的一致性

目的 分析胸中下段食管鳞癌隆突下淋巴结转移与CT影像学特征之间的相关性,为CT诊断提供依据。方法 选取2012—2014年间手术切除的174例胸中下段食管鳞癌患者,分析隆突下淋巴结转移与影像学CT扫描淋巴结特点的关系。结果 全组共清扫4 862枚淋巴结,平均每例清扫淋巴结（27.94±11.6）枚,转移淋巴结306枚,转移率57.47%（100/174）,转移度为6.29%（306/4862）。其中,隆突下淋巴结转移率为17.24％（30/174）,转移度为6.57％（44/670）。隆突下淋巴结转移与CT扫描淋巴结的短长径之比及淋巴结短径具有相关性（r_s=-0.448, P<0.001; r_s=0.378, P=0.002）。隆突下淋巴结转移的CT诊断与术后病理具有一致性（Kappa=0.628, P<0.001）,一致率为89.66%,特异性为94.44%,敏感度为66.67%,误诊率为5.56%,漏诊率为33.33%,阳性预测值为71.43%,阴性预测值为93.15%。结论 （1）胸中下段食管鳞癌隆突下淋巴结转移与CT中淋巴结的短长径之比及淋巴结短径具有相关性;（2）术前CT扫描隆突下淋巴结转移与术后病理具有一致性。     

^18F—FDGPET／CT显像与CT增强在肾癌诊断中的对比研究

目的:评价18F-脱氧葡萄糖(18F-fluorodeoxyglucose,18F-FDG)PET/CT显像对肾癌诊断和治疗方案选择的临床应用.方法:回顾性分析50例临床诊断为肾癌患者的全身18F-FDG PET/CT及CT平扫加增强的影像学资料,比较两者对肾癌的诊断价值.结果:50例中,经手术病理证实为肾癌的有41例,其余9例因18F-FDG PET/CT显像发现远处转移放弃手术.18F- FDG PET/CT检查敏感度80%;CT平扫加增强敏感度92%.9例转移病例中4例为腹膜后淋巴结转移,2例两肺多发转移,2例伴有下腔静脉和肾静脉癌栓形成,1例骨转移合并肝转移,而CT平扫加增强仅发现1例肾静脉和下腔静脉癌栓形成.结论:18F-FDG PET/CT对诊断原发性肾癌的敏感性不如CT,但对淋巴结转移及远处转移的诊断优于CT,对肾癌的分期及治疗方案的选择有重要意义.     

18F-FDG PET/CT显像在食管癌分期中的应用

目的:探讨18F-FDG PET/CT显像在食管癌分期中的应用价值.方法:对23例病理学确诊的食管癌患者,术前1周行全身PET/CT显像,根据病理结果评价PET/CT显像在食管癌分期中的应用价值.结果:19例患者进行了食管癌切除和淋巴结清除术,PET/CT显像发现50处病灶,与病理结果相比较,假阳性5处,假阴性3处,PET/CT诊断灵敏性为94%,特异性为76%;另4例患者因PET/CT发现多发转移而改变了治疗方案.结论:应用18F-FDG PET/CT进行食管癌检查能显著提高分期的敏感性和准确性,具有较好的临床应用前景.     

胸段食管鳞癌淋巴结转移强度和淋巴结清扫手术方式分析

背景与目的:淋巴结转移强度包括淋巴结转移数量和淋巴结转移度。淋巴结转移度即术后病理证实的淋巴结转移数和切除淋巴结数的比值。这两个指标是评估食管癌分期和预后的重要指标。本研究探讨胸段食管鳞癌淋巴结转移强度以及影响淋巴结转移强度的因素,进而探讨淋巴结清扫术式。方法:在中山大学附属第二医院手术切除的120例食管鳞癌患者,术中按美国胸科协会(AST)Casson修订淋巴结分组清扫淋巴结。结果:120例胸段食管鳞癌清扫淋巴结2631个,平均每例22个。胸上段食管鳞癌向颈部转移的淋巴结转移度(20.9%)大于胸中段(12.9%)和胸下段食管癌(6.8%)(P<0.05)。胸下段淋巴结向腹部胃周转移淋巴结转移度(37.5%)大于胸中段(17.5%)和胸上段食管癌(7.1%)(P<0.05)。隆突淋巴结转移以中段多见。食管癌浸润深度、食管癌分化、食管环壁生长程度与淋巴结转移强度显著相关(P<0.05),食管癌病变长度与转移强度不相关(P>0.05)。经右胸三野淋巴结清扫术后生存时间优于经左胸二野淋巴结清扫术(P<0.05)。结论:食管癌术中应注意淋巴结转移强度高的区域淋巴结清扫。食管癌浸润深度、食管癌分化、食管环壁生长程度是影响淋巴结转移强度的重要因素。在胸段食管癌淋巴清扫手术中,经右胸三野淋巴结清扫明显优于经左胸二野淋巴结清扫术。     

食管癌转移淋巴结大小和肿瘤浸润深度对18F-FDG SPET/CT诊断准确性的影响

目的 评价18F-FDG SPET/CT诊断食管癌淋巴结转移和病变长度的准确性.方法 选择首程治疗行颈、胸、腹三野淋巴结清扫的胸段食管癌根治术患者40例,术前1周内行18F-FDG SPET/CT检查和食管x线钡餐检查,将18F-FDG SPET/CT诊断的食管癌转移淋巴结大小及病变长度与术后病理诊断及术中测量进行对比...     

International clinical trials: perspectives of clinical research coordinators

There are several different task roles among the co-medicals who are involved in international clinical trials (ICTs). In this review article, several issues related with ICTs from the view point of clinical research coordinators (CRCs) will be discussed. The discussions include interview results from eight CRCs of four institutions who have been involved in ICTs, current status of education for co-medicals in the field of ICTs, and future perspectives of ICTs from the CRC's view point. The following topics are especially focused in the discussion. 1) It is necessary to establish the infra-structure for free discussion among the ICT team so that opinions of co-medicals as the operation managers of the participating institutions can be openly shared and importantly taken into account. 2) It is also important for co-medicals to conduct research studies to clarify the problems in the current ICT support systems. 3) Lastly, the significance of early involvement of CRCs into the ICT protocol development must be emphasized, because the quality of protocols will be better improved by the practical insight of CRCs, and consequently, the accomplishment of the ICT, such as the speed and the data quality, may be accelerated.     

鼻咽癌’92分期临床验证

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Globalization of clinical trials

Based on reviews of the Japanese clinical trial situation in lung cancer, gastric cancer, prostate cancer and breast cancer, it was clear that much progress has been made in short time. There are considerable differences between Japan and the West and also differences between clinical areas in Japan. For regulatory purposes bridging studies have become increasingly important. Use of identical protocols are required for effective bridging. Participations in global phase III trials is the best way of achieving registration in Japan. For successful global trials in Japan it is important to include Japanese investigators in the preparation of the protocol and to recognise the challenges facing such a project. Clinical practice in diagnosis and treatment have many differences, thus it is recommended to have clear and detailed information in the protocol. Hard end points like survival are important since they are not biased by cultural differences. There are clear difficulties with HE or QOL outcomes. The emergence of focus on evidence based medicine is also happening in Japan and will help to harmonize documentation across the world. For large adjuvant or prevention cancer global trials are essential. To facilitate global studies further development of infrastructure is necessary in Japan. Use of electronic data capture web based communication etc. will help overcome communication difficulties. Other improvements that will make Japanese participation in global trials easier and better include establishment of clinical trial centre at each hospital, introduction of trial coordinators or study nurses and an improved collaboration with company staff. A critical issue that also need addressing is agreement of centre target recruitment. We need to introduce a new flexible system in Japan if participation in global trial is to be optimised. If we can address these issues Japanese investigators and collaborative groups should be able to initiate and lead global trials in the future.     

Review of clinical radioimmunotherapy

Radioimmunotherapy involves a form of biologically targeted radiopharmaceutical treatment in which a radioactive isotope (typically a short-range, high-energy beta-emitter) is chemically bound to a target-specific monoclonal antibody or fragment. Thus, these radioimmunoconjugates combine the exquisite targeting specificity of the humoral immune system with the known cancer-killing power of high-energy radiotherapy. To date, two radioimmunotherapy agents have been fully approved for commercial use: 90Yttrium ibritumomab tiuxetan and (131)Iodine tositumomab. Both compounds target the CD20 surface molecule found on normal and malignant B cells, and both are medically indicated for the treatment of indolent B-cell lymphoma and related conditions. Clinical results are excellent (20-40% complete response rates and 60-80% overall response rates) and toxicity is typically quite mild. Current research is now attempting to both explore the biology of these compounds and to expand the spectrum of CD20+ diseases that could be treated using either or both of these active agents. Concurrently, work is in progress to achieve the same excellent clinical results using antibodies specific for other, more common epithelial tumors. This work is at an earlier stage than the lymphoma work, partly due to the high innate radiosensitivity of the lymphoid system. Thus, various enhancement methodologies are being explored to increase clinical response rates for these solid tumors, and a number of solid tumor RIT agents are now in early-stage clinical trials. The most likely pattern of use for this field in the next 5 years will probably involve combination or sequential regimens incorporating both radioimmunotherapy and more conventional chemotherapy or external radiotherapy.     

The impact of clinical practice guidelines and clinical trials on treatment decisions

With increasing numbers of clinical practice guidelines (CPGs) becoming available to guide physicians, it is important to understand how guidelines are developed. Of importance, is evaluation of the scientific evidence on which guidelines are based, indeed whether the guideline is evidence based or based on expert opinion alone. This report will review in general, guideline development. The impact of CPGs, including expected outcomes, as well as potential harms is discussed. Clinical trials, meta analyses and CPGs relevant to the treatment of lung cancer are reviewed.     

SEOM clinical guidelines for using molecular markers in clinical practice

Nowadays, treatment selection for most types of cancers is based on anatomical, histological and clinical criteria, which are defined by the selection criteria used in registration phase III trials. However, different cancers present distinct molecular features, so the current approach results in a lack of specificity of cancer therapy, which is associated with decreased efficacy and unnecessary toxicities and costs. Molecular diagnostics has proved able to predict the efficacy of selected targeted therapies. This allows the selection of specific treatments for different types of cancer, increasing their efficiency. Even though the number of treatments for solid tumours that can be selected based on molecular diagnostic tools is limited, much effort is being put into the identification of new biomarkers. This guideline reviews molecular diagnostic biomarkers that allow selection of specific therapies that have obtained regulatory approval as treatment of solid tumours.     

The process of clinical trials: a model for successful clinical trial participation

PURPOSE/OBJECTIVES: To present barriers and strategies related to successful clinical trial participation and integrate them into a model for successful trial participation. DATA SOURCES: The proposed model was developed based on a literature review related to clinical trial participation, review of empirical studies related to clinical trials, and experiences with subject participation. DATA SYNTHESIS: Successful clinical trial participation depends on study design, participant factors, issues related to ethnic diversity, the informed consent process, and physician factors. CONCLUSIONS: Clinical trial participation is critical for all disciplines. However, nurses either are researchers or co-investigators with physicians on clinical trials, and it is critical for them to understand specific barriers and success strategies for patient participation. Future studies need to be conducted related to participation in nursing clinical trial research. These study results will facilitate successful nursing clinical trials. IMPLICATIONS FOR NURSING PRACTICE: This model can be used in implementation of clinical trials across disciplines prior to and during enrollment of patients into studies.