Randomized Clinical Trial of Endobronchial Ultrasound Needle Biopsy With and Without Aspiration
Mené sur 307 patients présentant des ganglions lymphatiques suspects dans la région hilaire ou médiastinale du thorax, cet essai prospectif randomisé compare l'impact de deux techniques de prélèvement à l'aiguille sous contrôle échographique, l'une par ponction-aspiration transbronchique, l'autre par capillarité, sur la qualité des échantillons prélevés et le diagnostic
Background: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is performed with a dedicated 22- or 21-gauge needle while suction is applied. Fine-needle sampling without suction (capillary sampling) has been studied for endoscopic ultrasound and for biopsies at various body sites and has resulted in similar diagnostic yield and fewer traumatic samples. However, the role of EBUS-guided transbronchial needle capillary sampling (EBUS-TBNCS) remains to be determined.Methods: Adults with suspicious hilar or mediastinal lymph nodes (LNs) were included in a single-blinded prospective randomized trial comparing EBUS-TBNA and EBUS-TBNCS. The primary endpoint was concordance rate between the two techniques in terms of adequacy and diagnosis of cytologic samples. Secondary endpoint was concordance rate between the two techniques in terms of quality of samples.Results: A total of 115 patients and 192 LNs were studied. Concordance between EBUS-TBNA and EBUS-TBNCS was high, with no significant difference in adequacy (88% vs. 88%, respectively [P=0.858]; concordance rate, 83.9% [95% confidence interval (CI), 77.9-88.8]); diagnosis (36% vs. 34%, respectively [P=0.289]; concordance rate, 95.8% [95% CI, 92-92.8]); diagnosis of malignancy (28% vs. 26%, respectively [P=0.125]; concordance rate, 97.9% [95% CI, 94.8-99.4]); or sample quality (concordance rate, 83.3% [95% CI, 73.3-88.3]). Concordance between EBUS-TBNA and EBUS-TBNCS was high irrespective of LN size (<1 cm vs >1 cm).Conclusions: Regardless of LN size, no differences in adequacy, diagnosis, and quality were found between samples obtained using EBUS-TBNA and those obtained using EBUS-TBNCS. There is no evidence of benefit of the practice of applying suction to EBUS-guided biopsies.Trial registry: ClinicalTrials.gov registry; No.: NCT00886847; URL: www.clinicaltrials.gov
Chest , résumé, 2011