BackgroundIn case of suspicious lymph nodes on computed tomography (CT) or fluorodeoxyglucose positron emission tomography (FDG-PET), advanced tumour size or central tumour location in patients with suspected non-small cell lung cancer (NSCLC), Dutch and European guidelines recommend mediastinal staging by endosonography (endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS)) with sampling of mediastinal lymph nodes. If biopsy results from endosonography turn out negative, additional surgical staging of the mediastinum by mediastinoscopy is advised to prevent unnecessary lung resection due to false negative endosonography findings. We hypothesize that omitting mediastinoscopy after negative endosonography in mediastinal staging of NSCLC does not result in an unacceptable percentage of unforeseen N2 disease at surgical resection. In addition, omitting mediastinoscopy comprises no extra waiting time until definite surgery, omits one extra general anaesthesia and hospital admission, and may be associated with lower morbidity and comparable survival. Therefore, this strategy may reduce health care costs and increase quality of life. The aim of this study is to compare the cost-effectiveness and cost-utility of mediastinal staging strategies including and excluding mediastinoscopy.Methods/designThis study is a multicenter parallel randomized non-inferiority trial comparing two diagnostic strategies (with or without mediastinoscopy) for mediastinal staging in 360 patients with suspected resectable NSCLC. Patients are eligible for inclusion when they underwent systematic endosonography to evaluate mediastinal lymph nodes including tissue sampling with negative endosonography results. Patients will not be eligible for inclusion when PET/CT demonstrates ‘bulky N2-N3’ disease or the combination of a highly suspicious as well as irresectable mediastinal lymph node. Primary outcome measure for non-inferiority is the proportion of patients with unforeseen N2 disease at surgery. Secondary outcome measures are hospitalization, morbidity, overall 2-year survival, quality of life, cost-effectiveness and cost-utility. Patients will be followed up 2 years after start of treatment.DiscussionResults of the MEDIASTrial will have immediate impact on national and international guidelines, which are accessible to public, possibly reducing mediastinoscopy as a commonly performed invasive procedure for NSCLC staging and diminishing variation in clinical practice.Trial registrationThe trial is registered at the Netherlands Trial Register on July 6th, 2017 (NTR 6528).Electronic supplementary materialThe online version of this article (10.1186/s12893-018-0359-6) contains supplementary material, which is available to authorized users.
Introduction: Confirmatory mediastinoscopy after negative endosonography findings is advised by the guidelines on patients with resectable NSCLC and suspected intrathoracic nodes on fludeoxyglucose F 18 positron emission tomography-computed tomography. Its role however is under debate owing to its limited nodal metastasis detection rate, morbidity, associated treatment delay, and unknown impact on survival. Methods: Systematic review and meta-analysis of studies on invasive mediastinal staging in patients with (suspected) NSCLC. The Medline, Embase, and Cochrane databases were searched until September 19, 2018, without year or language restrictions. The Quality Assessment Tool for Diagnostic Accuracy Studies, version 2, was used to evaluate the risk of bias and applicability of the included studies. Rates of unforeseen N2 disease were assessed for endobronchial ultrasound and/or endoscopic ultrasound staging strategies with or without confirmatory mediastinoscopy. Additionally, the complication rates of cervical video mediastinoscopy for mediastinal staging of NSCLC were investigated. Results: A total of 5073 articles were found, of which 42 studies or subgroups (covering a total of 3248 patients undergoing the surgical reference standard of treatment) were considered in the analysis. Random effects metaanalysis of endosonography with or without confirmatory mediastinoscopy showed rates of unforeseen N2 disease of 9.6% (95% confidence interval [CI]: 7.8%-11.7%, I 2 ¼ 30%) versus 9.9% (95% CI: 6.3%-15.2%, I 2 ¼ 73%), respectively. Random effects meta-analysis of mediastinoscopy (eight studies [1245 patients in total]) showed a complication rate of 6.0% (95% CI: 4.8%-7.5%), with laryngeal recurrent nerve palsy accounting for 2.8% (95% CI: 2.0%-4.0%). Conclusion: 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 mediastinoscopy.
OBJECTIVES Surgical resection is widely employed as a potential curative treatment option for patients with limited lung metastases originating from a wide range of primary tumours. However, there are no clear national or international practice guidelines and, thereby, the risk for potential practice variation exists. This study aims to define the current practice for the surgical treatment of pulmonary metastases in the Netherlands by using data from the Dutch Lung Cancer Audit for Surgery (DLCA-S). METHODS Data from the DLCA-S were used to analyse patients undergoing a parenchymal lung resection for the treatment of pulmonary metastases between 2012 and 2017. Volume of metastasectomies per hospital was calculated as a proportion of the volume of primary lung cancer resection. Studied outcomes were overall complications and postoperative mortality and complicated course. For the latter, both the national average and between-hospital variation were calculated. RESULTS A total of 2090 patients, distributed over 45 Dutch hospitals, were included for analysis. The most common primary cancer was colorectal carcinoma (N = 1087, 52.0%) followed by the urogenital carcinoma (N = 296, 14.2%). The most common type of parenchymal resection was a wedge resection (N = 1477, 70.7%) followed by a lobectomy (N = 424, 20.3%). Resection was performed minimally invasively in 1548 patients (74.1%) with a conversion rate of 3.8%. Resection of a solitary metastasis was performed in 1663 patients (79.6%). In 40 patients (1.9%), 4 or more metastases were resected. A postoperative complicated course was noted in 3.6%, and the 30-day mortality rate was 0.7%. The variety between hospitals in the volume of metastasectomies in proportion to the volume of primary lung cancer resections was 3.4–41.5%. CONCLUSIONS This analysis of the DLCA-S registry provides a unique insight into current practice on pulmonary metastasectomies in the Netherlands over a 6-year period. The rate of postoperative adverse outcome was limited, and the morbidity and mortality were lower compared to primary lung cancer resections in the DLCA-S database.
Background: Thoracic endovascular aortic repair (TEVAR) requires large-bore vascular access due to the considerable diameters of the endoprosthesis and delivery device. The preclose technique preceding endograft delivery has opened the door for an evolved access strategy. In addition, treatment under local anesthesia offers the advantage of optimal neuromonitoring. The goal of this study was to analyze the efficacy and safety of percutaneous TEVAR under local anesthesia. Methods: All patients undergoing TEVAR in an elective setting at the Antwerp University Hospital between June 2012 and June 2015 were prospectively entered into an endovascular database. This database was queried for demographics, procedural details, and access-related complications. All patients underwent a percutaneous approach with the Perclose Proglide under local anesthesia. Results: This review identified 34 patients in whom 37 percutaneous TEVAR procedures were completed under local anesthesia. All patients experienced adequate analgesia, and no conversions to general anesthesia were implemented. The mean size of the arteriotomy was 23.8 ± 1.3 French (F). The number of Proglide deployments was 80, with an 8% rate of failure on deployment. There were no conversions to surgical cutdown, and adequate hemostasis was obtained in all procedures. The incidence of postprocedural access-related complications was 3%. Conclusion: Local anesthesia for percutaneous TEVAR can be performed safely and effectively. The percutaneous approach facilitates local anesthesia, which provides the added benefit of early recognition of neurologic complications while maintaining a low risk
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