The following sections describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
A randomised controlled trial (RCT) of 293 patients investigated by transbronchial biopsy (TBB) with or without EBUS guidance reported a diagnostic yield of 79% (48 out of 61) for malignant lesions and 69% (18 out of 26) for benign lesions in the EBUS–TBB group compared with 55% (46 out of 83) and 44% (16 out of 36) in the TBB-alone group (without EBUS guidance).
An RCT of 202 patients investigated by either EBUS–TBB plus bronchial washing (BW) or EBUS transbronchial needle aspiration (TBNA) plus TBB plus BW, reported diagnostic yields of 61% (57 out of 94) and 78% (69 out of 88) respectively (p=0.015). Without EBUS guidance, the diagnostic yield was 63% (55 out of 88) for TBNA, 49% (89 out of 182) for TBB (p=0.049 compared with TBNA) and 20% (36 out of 182) for BW (p<0.001 compared with TBNA).
An RCT of 120 patients investigated by EBUS–TBB, or electromagnetic navigation bronchoscopy (ENB)–TBB, or a combination of EBUS or ENB–TBB reported diagnostic yields of 69% (27 out of 39), 59% (23 out of 39) and 88% (35 out of 40) respectively (p=0.02 for comparisons between the groups).
A non-randomised comparative study of 261 diagnostic procedures using EBUS–TBB (using a guide sheath [GS]) or percutaneous CT-guided fine needle aspiration (CT–FNA) reported sensitivity values of 66% (93 out of 140) and 64% (77 out of 121) respectively (significance not stated).
The Specialist Advisers listed key efficacy outcomes as diagnostic yield, sensitivity, specificity, positive and negative predictive values, avoidance of CT-guided procedures (that is, reducing radiation exposure for the patient) and patient acceptability.
The RCT of 120 patients reported pneumothorax in 5% (2 out of 39) of the EBUS–TBB group, 5% (2 out of 39) of the ENB–TBB group and 8% (3 out of 40) of the combined EBUS/ENB–TBB group; 4 patients were treated with chest drain insertion and 1 was managed with aspiration and observation. The other 2 patients were managed by observation and supplemental oxygen.
Pneumothorax was reported in 1% (2 out of 140) of patients in the EBUS–GS transbronchial lung biopsy group compared with 22% (27 out of 121) of patients in the percutaneous CT–FNA group (p<0.01) in the non-randomised comparative study of 261 procedures.
Pneumothorax was reported in 3% (3 out of 119) of patients in the TBB-alone group compared with none of the patients in the EBUS–TBB group in the RCT of 293 patients. Pneumothorax determined by chest radiograph taken 1 to 2 hours after the procedure was reported in 2% (2 out of 88) of patients in the EBUS–TBNA plus TBB plus BW group and 2% (2 out of 94) of patients in the EBUS–TBB plus BW group in the RCT of 202 patients.
The RCT of 293 patients reported bleeding in none of the patients in the EBUS-TBB group compared with 6% (7 out of 119) of patients in the TBB-alone group. The RCT of 202 patients reported bleeding in 5% (4 out of 88) of patients in the EBUS–TBNA plus TBB plus BW group compared with 2% (2 out of 94) of patients in the EBUS–TBB plus BW group.
The Specialist Advisers listed adverse events reported in the literature as pneumothorax and haemorrhage. They listed a theoretical adverse event as false negative rate.
The Committee noted the risk of false negative results using this procedure. Any negative or inconclusive findings should be investigated using other biopsy procedures.