Elsevier

The Lancet

Volume 361, Issue 9366, 19 April 2003, Pages 1326-1330
The Lancet

Articles
Standard pleural biopsy versus CT-guided cutting-needle biopsy for diagnosis of malignant disease in pleural effusions: a randomised controlled trial

https://doi.org/10.1016/S0140-6736(03)13079-6Get rights and content

Summary

Background

Over 200 000 pleural effusions are attributable to cancer in the UK and USA every year. Cytological examination of pleural fluid classifies about 60% of malignant effusions. Pleural biopsy needs to be done in the remaining cases. We aimed to assess whether CT-guided biopsy is an improvement over standard pleural biopsy in this setting.

Methods

50 consecutive patients with cytologically negative suspected malignant pleural effusions were recruited. All had a contrast-enhanced thoracic CT scan to assess pleural thickening. Patients were randomly allocated, stratified by baseline pleural thickening, to either Abrams' pleural biopsy (standard care; n=25) or CT-guided cutting needle biopsy (n=25). Sensitivity for pleural malignancy from the biopsy specimen was the primary endpoint, with the patient's clinical outcome after 1 year being the diagnostic gold standard. Analysis was per protocol.

Findings

Three patients did not undergo biopsy. Abrams' biopsy correctly diagnosed malignancy in eight of 17 patients (sensitivity 47%, specificity 100%, negative predictive value 44%, positive predictive value 100%). CT-guided biopsy correctly diagnosed malignancy in 13 of 15 (sensitivity 87%, specificity 100%, negative predictive value 80%, positive predictive value 100%; difference in sensitivity between Abrams' and CT-guided 40%, 95% CI 10–69, p=0·02). Diagnostic advantage was similar in patients proving to have mesothelioma.

Interpretation

Primary use of CT-guided biopsy would avoid doing at least one Abrams' biopsy for every 2·5 CT-guided biopsies undertaken. In cytology-negative suspected malignant pleural effusions, CT-guided pleural biopsy is a better diagnostic test than Abrams' pleural biopsy.

Introduction

About 40 000 cases of pleural effusion are attributable to cancer every year in the UK, and 175 000 in the USA.1 Incidence of primary pleural malignant disease— mesothelioma—is rapidly rising in the UK, and is predicted to account for about 1% of all deaths in UK men born in the 1940s.2, 3 Cytological examination of pleural fluid for malignant cells establishes a positive diagnosis of malignancy in only 60% of carcinomatous effusions4, 5, 6, 7, 8, 9, 10, 11 and 30% of effusions secondary to mesothelioma.12, 13 Pleural biopsy to enable histological examination is needed for accurate diagnosis in the remainder. Pleural biopsy is therefore an important diagnostic method, which will be of growing relevance during the predicted mesothelioma epidemic of the next 20 years.2, 3

Despite the substantial burden of disease for which pleural biopsy is indicated, to our knowledge, no randomised trials have been done to assess the optimum diagnostic method, and no improvement has been made in the technique, which has been used for over 40 years. The standard technique uses a reverse bevel needle, such as the Abrams' needle,8, 14, 15 with local anaesthetic and without image guidance. This technique is associated with a substantial incidence of complications, including pneumothorax, haemothorax, and empyema, and in rare cases can be fatal.4, 6, 7, 8, 16 Furthermore, yield over pleural fluid cytology alone is increased by only 7–26%,5, 7, 16 and the procedure is painful, especially when done by inexperienced operators.

CT-guided cutting-needle biopsy of pleural tissue associated with a pleural effusion is a relatively new technique compared with Abrams' biopsy.17, 18 Results of observational series suggest this technique might improve diagnostic sensitivity to about 80% for pleural malignancy.17, 18, 19, 20 However, these studies are nonrandomised, tend to include CT-guided and ultrasound-guided procedures, and are mainly done in patients without pleural effusions.19, 20 If CT-guided biopsy is strikingly superior to traditional Abrams' biopsy, this technique would produce better diagnostic information from fewer passes—and by inference fewer complications and greater acceptability to patients. Reduction of the number of pleural procedures in patients with mesothelioma is especially important, because one in three biopsy sites are invaded by this tumour unless the sites are irradiated.21

We therefore did a prospective trial to measure sensitivity for malignant disease with standard Abrams' biopsy and with CT-guided needle biopsy, to assess whether CT-guided biopsy was an improvement over the standard technique.

Section snippets

Study design and setting

This study was a prospective, parallel, randomised trial done in one centre (Oxford Centre for Respiratory Medicine, Oxford, UK). Patients with undiagnosed pleural effusions are referred to the Oxford unit directly from general practitioners (60%), from other local hospital consultants (30%), and occasionally from respiratory consultants in other neighbouring health authorities (10%). The population served by this unit has a low prevalence of asbestos exposure and hence a low frequency of

Results

During the recruitment period, 53 patients who were eligible for the study were identified; 50 consented to enter the study (figure 3). 45 of these presented directly to the Oxford Centre for Respiratory Medicine, the other five were referred from other hospitals in the region. 46 of the patients had one non-diagnostic pleural aspiration before randomisation; the remaining four had two negative aspirations. None had undergone a pleural biopsy procedure before trial entry. Characteristics of

Discussion

We have shown that CT-guided pleural biopsy is more effective than standard Abrams' biopsy in diagnosis of malignant pleural disease. The size of this advantage is considerable. Standard Abrams' biopsy correctly diagnosed malignancy in 47% of patients eventually proved to have pleural malignancy, whereas CT-guided biopsy accurately identified 87%. Thus, undertaking CT-guided biopsy as the initial procedure would avoid doing repeated biopsy in 40% of patients compared with current practice,

References (29)

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