Biomaterial Database

Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. 2010

Jouke T Annema, and Jan P van Meerbeeck, and Robert C Rintoul, and Christophe Dooms, and Ellen Deschepper, and Olaf M Dekkers, and Paul De Leyn, and Jerry Braun, and Nicholas R Carroll, and Marleen Praet, and Frederick de Ryck, and Johan Vansteenkiste, and Frank Vermassen, and Michel I Versteegh, and Maud Veseliç, and Andrew G Nicholson, and Klaus F Rabe, and Kurt G Tournoy

Department of Pulmonology, C3-P, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands. j.t.annema@lumc.nl

BACKGROUND Mediastinal nodal staging is recommended for patients with resectable non-small cell lung cancer (NSCLC). Surgical staging has limitations, which results in the performance of unnecessary thoracotomies. Current guidelines acknowledge minimally invasive endosonography followed by surgical staging (if no nodal metastases are found by endosonography) as an alternative to immediate surgical staging. OBJECTIVE To compare the 2 recommended lung cancer staging strategies. METHODS Randomized controlled multicenter trial (Ghent, Leiden, Leuven, Papworth) conducted between February 2007 and April 2009 in 241 patients with resectable (suspected) NSCLC in whom mediastinal staging was indicated based on computed or positron emission tomography. METHODS Either surgical staging or endosonography (combined transesophageal and endobronchial ultrasound [EUS-FNA and EBUS-TBNA]) followed by surgical staging in case no nodal metastases were found at endosonography. Thoracotomy with lymph node dissection was performed when there was no evidence of mediastinal tumor spread. METHODS The primary outcome was sensitivity for mediastinal nodal (N2/N3) metastases. The reference standard was surgical pathological staging. Secondary outcomes were rates of unnecessary thoracotomy and complications. RESULTS Two hundred forty-one patients were randomized, 118 to surgical staging and 123 to endosonography, of whom 65 also underwent surgical staging. Nodal metastases were found in 41 patients (35%; 95% confidence interval [CI], 27%-44%) by surgical staging vs 56 patients (46%; 95% CI, 37%-54%) by endosonography (P = .11) and in 62 patients (50%; 95% CI, 42%-59%) by endosonography followed by surgical staging (P = .02). This corresponded to sensitivities of 79% (41/52; 95% CI, 66%-88%) vs 85% (56/66; 95% CI, 74%-92%) (P = .47) and 94% (62/66; 95% CI, 85%-98%) (P = .02). Thoracotomy was unnecessary in 21 patients (18%; 95% CI, 12%-26%) in the mediastinoscopy group vs 9 (7%; 95% CI, 4%-13%) in the endosonography group (P = .02). The complication rate was similar in both groups. CONCLUSIONS Among patients with (suspected) NSCLC, a staging strategy combining endosonography and surgical staging compared with surgical staging alone resulted in greater sensitivity for mediastinal nodal metastases and fewer unnecessary thoracotomies. BACKGROUND clinicaltrials.gov Identifier: NCT00432640.

UI	MeSH Term	Description	Entries
D008175	Lung Neoplasms	Tumors or cancer of the LUNG.	Cancer of Lung,Lung Cancer,Pulmonary Cancer,Pulmonary Neoplasms,Cancer of the Lung,Neoplasms, Lung,Neoplasms, Pulmonary,Cancer, Lung,Cancer, Pulmonary,Cancers, Lung,Cancers, Pulmonary,Lung Cancers,Lung Neoplasm,Neoplasm, Lung,Neoplasm, Pulmonary,Pulmonary Cancers,Pulmonary Neoplasm
D008197	Lymph Node Excision	Surgical excision of one or more lymph nodes. Its most common use is in cancer surgery. (From Dorland, 28th ed, p966)	Lymph Node Dissection,Lymphadenectomy,Dissection, Lymph Node,Dissections, Lymph Node,Excision, Lymph Node,Excisions, Lymph Node,Lymph Node Dissections,Lymph Node Excisions,Lymphadenectomies,Node Dissection, Lymph,Node Dissections, Lymph
D008207	Lymphatic Metastasis	Transfer of a neoplasm from its primary site to lymph nodes or to distant parts of the body by way of the lymphatic system.	Lymph Node Metastasis,Lymph Node Metastases,Lymphatic Metastases,Metastasis, Lymph Node
D008297	Male		Males
D008481	Mediastinoscopy	Endoscopic examination, therapy or surgery of the anterior superior mediastinum of the thorax.	Mediastinoscopic Surgical Procedures,Surgical Procedures, Mediastinoscopic,Mediastinoscopic Surgery,Surgery, Mediastinoscopic,Mediastinoscopic Surgeries,Mediastinoscopic Surgical Procedure,Mediastinoscopies,Procedure, Mediastinoscopic Surgical,Procedures, Mediastinoscopic Surgical,Surgeries, Mediastinoscopic,Surgical Procedure, Mediastinoscopic
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009367	Neoplasm Staging	Methods which attempt to express in replicable terms the extent of the neoplasm in the patient.	Cancer Staging,Staging, Neoplasm,Tumor Staging,TNM Classification,TNM Staging,TNM Staging System,Classification, TNM,Classifications, TNM,Staging System, TNM,Staging Systems, TNM,Staging, Cancer,Staging, TNM,Staging, Tumor,System, TNM Staging,Systems, TNM Staging,TNM Classifications,TNM Staging Systems
D011183	Postoperative Complications	Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.	Complication, Postoperative,Complications, Postoperative,Postoperative Complication
D002289	Carcinoma, Non-Small-Cell Lung	A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.	Carcinoma, Non-Small Cell Lung,Non-Small Cell Lung Cancer,Non-Small Cell Lung Carcinoma,Non-Small-Cell Lung Carcinoma,Nonsmall Cell Lung Cancer,Carcinoma, Non Small Cell Lung,Carcinomas, Non-Small-Cell Lung,Lung Carcinoma, Non-Small-Cell,Lung Carcinomas, Non-Small-Cell,Non Small Cell Lung Carcinoma,Non-Small-Cell Lung Carcinomas
D005260	Female		Females