Endobronchial ultrasound-guided transbronchial needle aspiration prevents mediastinoscopies in the diagnosis of isolated mediastinal lymphadenopathy: a prospective trial

Abstract

Rationale: Patients with isolated mediastinal lymphadenopathy (IML) are a common presentation to physicians, and mediastinoscopy is traditionally considered the "gold standard" investigation when a pathological diagnosis is required. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is established as an alternative to mediastinoscopy in patients with lung cancer.

Objective: To determine the efficacy and health care costs of EBUS-TBNA as an alternative initial investigation to mediastinoscopy in patients with isolated IML.

Methods: Prospective multicenter single-arm clinical trial of 77 consecutive patients with IML from 5 centers between April 2009 and March 2011. All patients underwent EBUS-TBNA. If EBUS-TBNA did not provide a diagnosis, then participants underwent mediastinoscopy.

Measurements and main results: EBUS-TBNA prevented 87% of mediastinoscopies (95% confidence interval [CI], 77-94%; P < 0.001) but failed to provide a diagnosis in 10 patients (13%), all of whom underwent mediastinoscopy. The sensitivity and negative predictive value of EBUS-TBNA in patients with IML were 92% (95% CI, 83-95%) and 40% (95% CI, 12-74%), respectively. One patient developed a lower respiratory tract infection after EBUS-TBNA, requiring inpatient admission. The cost of the EBUS-TBNA procedure per patient was £1,382 ($2,190). The mean cost of the EBUS-TBNA strategy was £1,892 ($2,998) per patient, whereas a strategy of mediastinoscopy alone was significantly more costly at £3,228 ($5,115) per patient (P < 0.001). The EBUS-TBNA strategy is less costly than mediastinoscopy if the cost per EBUS-TBNA procedure is less than £2,718 ($4,307) per patient.

Conclusions: EBUS-TBNA is a safe, highly sensitive, and cost-saving initial investigation in patients with IML. Clinical trial registered with ClinicalTrials.gov (NCT00932854).

Figures

Figure 1.

Flowchart of patients in the REMEDY (Clinical Trial of Endobronchial Ultrasound for the Diagnosis of Mediastinal Lymphadenopathy) trial. NSCLC = non–small cell lung cancer.

Figure 2.

Threshold sensitivity analysis showing the effect of variation in cost of endobronchial ultrasound–guided transbronchial needle aspiration (EBUS-TBNA). EBUS-TBNA prevented 87% of mediastinoscopies, with a 97.5% confidence interval of 78–96% (dashed lines). Assuming that 87% of mediastinoscopies can be prevented by EBUS-TBNA, the analysis demonstrates that the cost of the mediastinoscopy-alone strategy is more expensive than a strategy of EBUS-TBNA (followed by mediastinoscopy if EBUS-TBNA is negative) as long as EBUS-TBNA costs less than £2,718 (red line). Above this threshold the cost for EBUS-TBNA, mediastinoscopy alone is the less costly strategy. At the best estimate cost of EBUS-TBNA of £1,382 (purple line) the EBUS-TBNA strategy is cost-saving. 1 £UK = $1.58 USD (February 1, 2012).