Ultrasonic Elastography-guided Pleural Biopsy versus Traditional Thoracic Ultrasound-guided Pleural Biopsy for the Diagnosis of Pleural Effusion: A Multicentre Randomized Trial

Background Traditional thoracic ultrasound-guided pleural biopsy (TUSPB) is considered the initial method for histological diagnosis; however, its sensitivity for detecting malignant pleural effusion (MPE) is limited. Ultrasound elastography can be used to differentiate MPE from benign diseases by evaluating pleural stiffness. This study aimed to investigate whether ultrasonic elastography-guided pleural biopsy (UEPB) offers diagnostic accuracy superior to that of TUSPB for pleural effusions. Methods In this multicentre, randomised trial (ClinicalTrials.gov ID: NCT05781659 ), patients with pleural effusion of unknown origin were enrolled and randomized (1:1) to undergo either UEPB or TUSPB. The primary outcome measured was the sensitivity of UEPB in diagnosing MPE; the secondary outcomes were the diagnostic rate of the two methods in patients with different pleural thicknesses, and the safety of UEPB. Findings In total, 232 patients with pleural effusion were enrolled, 228 of whom were included in the analysis. The sensitivity for detecting MPE was significantly greater in the UEPB group than that in the TUSPB group (85.00% [51/60] versus 63.16% [36/57], p=0.007). Patients in the UEPB group had a significantly greater diagnostic yield than those in the TUSPB group did (87.83% [101/115] versus 76.99% [87/113], p=0.032). For patients with MPE and a pleural thickness ≤5 mm without who did not have pleural nodules, UEPB had a significantly greater sensitivity than did TUSPB (80.49% [33/41] versus 50.00% [15/30], p=0.007). The rates of procedure-related complications were similar between the UEPB and TUSPB groups (6.36% versus 8.33%, p=0.552). Interpretation UEPB was superior to TUSPB in the diagnosis of MPE with a similar safety profile.