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Endoscopic Ultrasound Reduces Surgical Mediastinal Staging in Lung Cancer

A Randomized Trial

¹ Long Oncologisch Netwerk Gent, Ghent University Hospital, Ghent, Belgium; ² Department of Respiratory Medicine, Amphia Hospital, Breda, The Netherlands; and ³ Department of Medical Statistics, Ghent University Hospital, Ghent, Belgium

Correspondence and requests for reprints should be addressed to Kurt Tournoy, M.D., Ph.D., Ghent University Hospital, Department of Respiratory Medicine, Building 7K12 I.E, De Pintelaan 185, 9000 Ghent, Belgium. E-mail: kurt.tournoy{at}ugent.be

Rationale: Assessment of mediastinal lymph nodes is recommended in patients with non–small cell lung cancer without distant metastases. Linear transesophageal endoscopic ultrasound with real-time guided fine-needle aspiration (EUS-FNA) is a promising, nonsurgical tool for mediastinal staging.

Objectives: We conducted a randomized controlled trial comparing surgical staging with EUS-FNA.

Methods: Patients with proven or suspected non–small cell lung cancer in whom mediastinal exploration was required were randomly assigned to undergo EUS-FNA or the appropriate surgical staging procedure. When EUS-FNA did not show malignant lymph node invasion, a confirmatory surgical staging procedure was done. A negative surgical staging procedure was followed by thoracotomy with systematic lymph node sampling. The primary endpoint was the rate of surgical staging interventions. The secondary endpoints were test performance of EUS-FNA and surgical staging, morbidity, and length of hospital stay, considering surgical staging was performed as an in-patient procedure.

Measurements and Main Results: A total of 40 patients were randomized: 19 to EUS-FNA, and 21 to surgical mediastinal staging. Patient and tumor characteristics were well balanced between both groups. For patients allocated to EUS-FNA, surgical staging was needed in 32% (P < 0.001). The sensitivity to detect malignant lymph node invasion was 93% (95% confidence interval, 66–99%) for EUS-FNA and 73% (95% confidence interval, 39–93%) for surgical staging (P = 0.29). Complication rate was 0% for EUS-FNA and 5% for surgical staging (P = 1.0). The median hospital stay was significantly shorter for EUS-FNA than for surgical staging (0 vs. 2 nights; P < 0.001).

Conclusions: EUS-FNA reduces the need for surgical staging procedures in patients with (suspected) lung cancer in whom a mediastinal exploration is needed.

Clinical trial registered with www.clinicaltrials.gov (NCT 00119470).

Key Words: lung cancer • staging • mediastinoscopy • endoscopic ultrasound with fine-needle aspiration

AT A GLANCE COMMENTARY Scientific Knowledge on the Subject Patient series have suggested that endoscopic ultrasound with real-time guided fine-needle aspiration (EUS-FNA) could reduce surgical staging of the mediastinum in lung cancer. This has never been demonstrated prospectively with a randomized, controlled trial comparing EUS-FNA with the gold standard, surgical staging. What This Study Adds to the Field This randomized controlled trial shows that EUS-FNA reduces the need for surgery, but also indicates its limitations. The data implicate EUS-FNA can be used in staging guidelines.

 

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