Endoscopic ultrasound guided biopsy performed routinely in lung cancer staging spares futile thoracotomies: Preliminary results from a randomised clinical trial
Introduction
Up to 10% of operations for non-small-cell lung cancer (NSCLC) result in explorative thoracotomies without tumour resection, and an additional 25–35% of the operations are unsuccessful because of postoperative recurrent disease [1], [2]. Therefore, surgery may be regarded as futile or unnecessary in up to 45% of patients operated, apparently because the stage of the disease is more advanced than expected preoperatively. This combined with the introduction of stage-dependent multi-modality treatment of NSCLC underlines the importance of exact staging of the disease.
During the past decade endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) has been introduced in respiratory medicine as an accurate method for obtaining biopsy specimens from mediastinal structures. A number of small and medium sized studies have been published [3], [4], [5], [6], [7], [8], [9], [10], [11], [12]. The majority of them present the results of EUS-FNA performed in patients selected by computed tomography (CT). The diagnostic values for such patients are relatively uniform with a sensitivity of around 90%, specificity and positive predictive value of 100%, negative predictive value of 80%, and an accuracy of 95% for mediastinal malignancy. Very few complications have been reported. At most centres where EUS-FNA is available, this method is therefore used in selected patients with mediastinal spread suspected by CT.
A few studies suggest that EUS-FNA can also diagnose mediastinal spread in patients without CT-suspicion of mediastinal malignancy [8], [5], [13]. In a recent study EUS-FNA demonstrated advanced disease in 17 of 69 patients (25%) without enlarged mediastinal lymph nodes by CT, with a sensitivity of 61% for advanced mediastinal disease [3].
Even though the literature thus indicates that routine use of EUS-FNA may be valuable in lung cancer staging, the level of evidence is relatively low, concerning the potential benefit for the patients in terms of spared invasive procedures, futile thoracotomies and survival. Studies investigating accuracy are not designed to show added value of diagnostic tests and generalisation of such results to predict an effect in routine practice is difficult. As a result, whether unselected NSCLC-patients will benefit from use of EUS-FNA in a routine clinical setting cannot be directly inferred from published studies. To our knowledge no randomised trials have been performed, where a strategy with EUS performed in all patients is compared with a conventional strategy.
In the present study, it was hypothesised that a significant number of futile thoracotomies could be spared by introducing a strategy with EUS-FNA in all NSCLC-patients considered for surgery with curative intent. The current strategy of conventional diagnostic methods (including EUS-FNA for selected patients) was compared with a strategy, in which EUS-FNA was performed in all patients.
Section snippets
Patients
Patients admitted to the Department of Pulmonology, Gentofte University Hospital, Copenhagen, who fulfilled the in- and exclusion criteria outlined in Table 1, were invited to participate. Prior to inclusion, all patients had undergone chest CT, bronchoscopy including trans-bronchial needle aspiration biopsy (TBNA), clinical evaluation and lung function tests. Trans-thoracic needle aspiration biopsy (TTNA) was performed, if indicated, and some patients underwent positron emission tomography
Baseline characteristics
Between November 2001 and February 2004, 104 patients with verified (n = 92) or highly suspected (n = 12) NSCLC were included. 53 patients were assigned to the routine EUS-FNA group and 51 patients to the CWU group. Baseline characteristics are outlined in Table 2.
EUS-FNA was performed in 50 patients (94%) in the routine EUS-FNA group and in 14 patients (27%) in the CWU group. Three patients in the routine EUS-FNA group did not undergo EUS-FNA for the following reasons: one patient became medically
Discussion
A significantly smaller proportion of patients underwent futile thoracotomy in the routine EUS-FNA group than in the CWU group. The reduction was apparently a result of an improved preoperative selection of surgically resectable and curable patients. The main effect of EUS-FNA was to upstage patients (34% in the routine EUS-FNA group, 22% in the CWU group), resulting in an almost significant reduction (from 29 to 11%; p = 0.08) of patients with per-operative mediastinal disease. The study, thus,
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