Unforeseen N2 Disease after Negative Endosonography Findings with or without Confirmatory Mediastinoscopy in Resectable Non-Small Cell Lung Cancer: A Systematic Review and Meta-Analysis.
TL;DR: The rate of unforeseen N2 disease after negative endosonography findings was similar in patients undergoing immediate lung tumor resection to those undergoing confirmatory mediastinoscopy first, at the cost of 6.0% rate of complications by mediastinescopy.
About: This article is published in Journal of Thoracic Oncology.The article was published on 2019-06-01 and is currently open access. It has received 28 citations till now. The article focuses on the topics: Mediastinoscopy.
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TL;DR: Although adherence to the European NSCLC mediastinal staging guideline on initial use of endosonography was good, 30% of endOSonography procedures were performed insufficiently and unforeseen N2 rates following staging by endos onography with or without confirmatory mediastinoscopy were comparable.
15 citations
TL;DR: Current indications of invasive staging in patients with radiologically normal mediastinum have to be re‐evaluated, especially for central tumour location.
Abstract: Mediastinal staging is a crucial step in the management of patients with NSCLC. With the recent development of novel techniques, mediastinal staging has evolved from an activity of interest mainly for thoracic surgeons to a joint effort carried out by many specialists. In this regard, the debate of cases in MDT sessions is crucial for optimal management of patients. Current evidence-based clinical guidelines for preoperative NSCLC staging recommend that mediastinal staging should be performed with increasing invasiveness. Image-based techniques are the first approach, although they have limited accuracy and findings must be confirmed by pathology in almost all cases. In this setting, the advent of radiomics is promising. Invasive staging depends on procedural factors rather than diagnostic performance. The choice between endoscopy-based or surgical procedures should depend on the local expertise of each centre. As the extension of mediastinal disease in terms of number of involved lymph nodes and nodal stations affects prognosis and the choice of treatment, systematic samplings are preferred over random targeted samplings. Following this approach, a diagnosis of single mediastinal nodal involvement can be unreliable if all reachable mediastinal nodal stations have not been assessed. The performance of confirmatory mediastinoscopy after a negative endoscopy-based procedure is controversial but currently recommended. Current indications of invasive staging in patients with radiologically normal mediastinum have to be re-evaluated, especially for central tumour location.
12 citations
TL;DR: The staging of mediastinal lymph nodes for lung cancer is crucial for planning treatments or reinterventions and the results from the most recent studies and current international guidelines are explained and revised.
Abstract: The staging of mediastinal lymph nodes for lung cancer is crucial for planning treatments or reinterventions. In potentially curable patients the aim of mediastinal staging is to exclude the presence of malignancy in mediastinal lymph nodes with a high level of accuracy while also considering clinical factors and the balance of the benefits and risks of tissue sampling techniques. Mediastinal staging is based on computed tomography (CT) and positron emission tomography (PET) and can be sufficient when no mediastinal abnormalities are present and the probability of unforeseen N2 disease is low. In the case of bulky lymph nodes with a high probability of malignancy in PET-CT, tissue confirmation is not normally required. If mediastinal sampling is needed it can be achieved by endosonographic techniques, including endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) or a combination of the two. Positive results do not need further confirmation. In the case of negative results, surgical techniques still play a role in the selected cases discussed by multidisciplinary lung cancer committees. New mediastinal surgical techniques including video-assisted cervical mediastinoscopy (VACM), video-assisted mediastinoscopic lymphadenectomy (VAMLA), and transcervical extended mediastinal lymphadenectomy (TEMLA) have been shown to be useful in selected patients. Final pathological staging is based on lymph node removal during surgery and can be achieved by taking one of two approaches: lymph node sampling or systematic lymph node sampling. The accuracy of PET-CT and mediastinal endosonography is lower for mediastinal restaging than it is for surgical techniques; their false positive and false negative (FN) rate is high and so, they require histological confirmation. Here we explain and revise the results from the most recent studies and current international guidelines.
9 citations
Cites methods from "Unforeseen N2 Disease after Negativ..."
...08 underwent surgical resection with or without prior surgical mediastinal staging (30)....
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TL;DR: Mediastinal staging for lung cancer includes both the assessment of mediastinal lymph nodes status before treatment and the postoperative pathological staging obtained by lymph-node removal performed during surgery.
Abstract: Mediastinal staging for lung cancer includes both the assessment of mediastinal lymph nodes status before treatment and the postoperative pathological staging obtained by lymph-node removal performed during surgery. In patients with early stage NSCLC, the aim is to exclude with the highest certainty and the lowest morbidity the presence of mediastinal node involvement. Before treatment, mediastinal staging is based on imaging techniques, endoscopic techniques, and surgical procedures. Final pathological staging is based on lymph-node removal performed with lung resection according with different modalities (sampling, systematic dissection, etc.) and various approaches (thoracotomy, VATS, robotic). Data and indications from literature evidences are reported and discussed.
7 citations
TL;DR: Invasive mediastinal nodal staging is recommended by guidelines in selected patients with resectable non-small cell lung cancer (NSCLC) as mentioned in this paper, followed by confirmatory mediastinoscopy in case of negative N2 or N3 cytology after endosonography.
Abstract: Invasive mediastinal nodal staging is recommended by guidelines in selected patients with resectable non-small cell lung cancer (NSCLC). Endosonography is recommended as initial staging technique, followed by confirmatory mediastinoscopy in case of negative N2 or N3 cytology after endosonography. Confirmatory mediastinoscopy however is under debate owing its limited additional diagnostic value, its associated morbidity and its delay in the start of lung cancer treatment. The MEDIASTrial examines whether confirmatory mediastinoscopy can be safely omitted after negative endosonography in mediastinal nodal staging of NSCLC. The present work is the proposed statistical analysis plan of the clinical consequences of omitting mediastinoscopy, which is submitted before closure of the MEDIASTrial and before knowledge of any results was done to enhance transparency of scientific behaviour. The primary outcome measure of this non-inferiority trial will be unforeseen N2 disease resulting from lobe-specific mediastinal lymph node dissection. For non-inferiority, the upper limit of the 95% confidence interval of the unforeseen N2 rate in the group without mediastinoscopy should not exceed 14.3% in order to probably have no negative impact on survival. Since this is a non-inferiority trial, both an intention to treat (ITT) and a per protocol (PP) analyses will be done. The ITT and the PP analyses should both indicate non-inferiority before the diagnostic strategy omitting mediastinoscopy will be interpreted as non-inferior to the strategy with mediastinoscopy. Secondary outcome measures include 30-day major morbidity and mortality, the total number of days of hospital care, overall and disease free 2-year survival, generic and disease-specific health related quality of life and cost-effectiveness and cost-utility of staging strategies with and without mediastinoscopy. The MEDIASTrial will determine if confirmatory mediastinoscopy can be omitted after tumour negative systematic endosonography in invasive mediastinal staging of patients with resectable NSCLC. Netherlands Trial Register NL6344/NTR6528
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5 citations
References
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TL;DR: It is concluded that H and I2, which can usually be calculated for published meta-analyses, are particularly useful summaries of the impact of heterogeneity, and one or both should be presented in publishedMeta-an analyses in preference to the test for heterogeneity.
Abstract: The extent of heterogeneity in a meta-analysis partly determines the difficulty in drawing overall conclusions. This extent may be measured by estimating a between-study variance, but interpretation is then specific to a particular treatment effect metric. A test for the existence of heterogeneity exists, but depends on the number of studies in the meta-analysis. We develop measures of the impact of heterogeneity on a meta-analysis, from mathematical criteria, that are independent of the number of studies and the treatment effect metric. We derive and propose three suitable statistics: H is the square root of the chi2 heterogeneity statistic divided by its degrees of freedom; R is the ratio of the standard error of the underlying mean from a random effects meta-analysis to the standard error of a fixed effect meta-analytic estimate, and I2 is a transformation of (H) that describes the proportion of total variation in study estimates that is due to heterogeneity. We discuss interpretation, interval estimates and other properties of these measures and examine them in five example data sets showing different amounts of heterogeneity. We conclude that H and I2, which can usually be calculated for published meta-analyses, are particularly useful summaries of the impact of heterogeneity. One or both should be presented in published meta-analyses in preference to the test for heterogeneity.
25,460 citations
TL;DR: The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
Abstract: Growing demand for health care, rising costs, constrained resources, and evidence of variations in clinical practice have triggered interest in measuring and improving the quality of health care delivery. For a valuable quality assessment, relevant data on outcome must be obtained in a standardized and reproducible manner to allow comparison among different centers, between different therapies and within a center over time.1–3 Objective and reliable outcome data are increasingly requested by patients and payers (government or private insurance) to assess quality and costs of health care. Moreover, health policy makers point out that the availability of comparative data on individual hospital's and physician's performance represents a powerful market force, which may contribute to limit the costs of health care while improving quality.4
Conclusive assessments of surgical procedures remain limited by the lack of consensus on how to define complications and to stratify them by severity.1,5–8 In 1992, we proposed general principles to classify complications of surgery based on a therapy-oriented, 4-level severity grading.1 Subsequently, the severity grading was refined and applied to compare the results of laparoscopic versus open cholecystectomy9 and liver transplantation.10 This classification has also been used by others11–13 and was recently suggested to serve as the basis to assess the outcome of living related liver transplantation in the United States (J. Trotter, personal communication). However, the classification system has not yet been widely used in the surgical literature.
The strength of the previous classification relied on the principle of grading complications based on the therapy used to treat the complication. This approach allows identification of most complications and prevents down-rating of major negative outcomes. This is particularly important in retrospective analyses. However, we felt that modifications were necessary, particularly in grading life-threatening complications and long-term disability due to a complication. We also felt that the duration of the hospital stay can no longer be used as a criterion to grade complications. Although definitions of negative outcomes rely to a large extend on subjective “value” appraisals, the grading system must be tested in a large cohort of patients. Finally, a classification is useful only if widely accepted and applied throughout different countries and surgical cultures. Such a validation was not done with the previous classification.
Therefore, the aim of the current study was 3-fold: first, to propose an improved classification of surgical complications based on our experience gained with the previous classification1; second, to test this classification in a large cohort of patients who underwent general surgery; and third, to assess the reproducibility and acceptability of the classification through an international survey.
23,435 citations
TL;DR: In this paper, the problem of interval estimation of a binomial proportion is revisited, and a number of natural alternatives are presented, each with its motivation and con- text, each interval is examined for its coverage probability and its length.
Abstract: We revisit the problem of interval estimation of a binomial proportion. The erratic behavior of the coverage probability of the stan- d ardWaldconfid ence interval has previously been remarkedon in the literature (Blyth andStill, Agresti andCoull, Santner andothers). We begin by showing that the chaotic coverage properties of the Waldinter- val are far more persistent than is appreciated. Furthermore, common textbook prescriptions regarding its safety are misleading and defective in several respects andcannot be trusted . This leads us to consideration of alternative intervals. A number of natural alternatives are presented, each with its motivation and con- text. Each interval is examinedfor its coverage probability andits length. Basedon this analysis, we recommendthe Wilson interval or the equal- tailedJeffreys prior interval for small n andthe interval suggestedin Agresti andCoull for larger n. We also provide an additional frequentist justification for use of the Jeffreys interval.
2,893 citations
TL;DR: A random-effects model to summarize the evidence about treatment efficacy from a number of related clinical trials and a discussion of repurposing the method for Big Data meta-analysis and Genome Wide Association Studies for studying the importance of genetic variants in complex diseases are reviewed.
1,744 citations
TL;DR: The Clatterbridge Cancer Centre and Liverpool Heart and Chest Hospital, Liverpool; University of Aberdeen, Aberdeen, UK; Center for Medical Imaging, University of Groningen, Groningen; Department of Radiation Oncology, VU University Medical Center, Amsterdam, The Netherlands; and Department of Thoracic Surgery, University Hospitals of Leicester NHS Trust, Leicester, UK.
1,498 citations