2 The procedure
2.1.1 In this guidance, 'peripheral lung lesions' describes lung lesions that cannot be visualised using conventional bronchoscopy because they do not protrude into the bronchial tree. This guidance is concerned only with the diagnosis of such lesions, and not with their treatment.
2.1.2 Patients with peripheral lung lesions are often asymptomatic and the abnormality is detected incidentally on chest X-ray or computed tomography (CT) scanning. Symptoms of cough, haemoptysis and breathlessness may be present, but are more often associated with endobronchial tumours that are accessible to standard bronchoscopic biopsy.
2.1.3 Current biopsy techniques include blind transbronchial lung biopsy, image-guided percutaneous lung biopsy, or (thoracoscopic or open) surgical biopsy.
2.2.1 The procedure can be undertaken with the patient under general anaesthesia or under local anaesthesia with or without sedation. The lesion is identified by prior CT, positron emission tomography (PET) or conventional chest X-ray imaging. A flexible fibreoptic bronchoscope with a radial mini-probe or catheter is inserted through the nose or mouth, and advanced towards the peripheral lung lesion using endobronchial ultrasound (EBUS) guidance. Once the bronchoscope is in the appropriate location, the ultrasound mini-probe or catheter is withdrawn and biopsy forceps or needles are introduced into the working channel to obtain a histological sample of the target lesion, with or without fluoroscopic guidance. Use of a guide sheath can help to keep the bronchoscope in place during the removal of the probe and insertion of biopsy instruments.
Sections 2.3 and 2.4 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.
2.3.1 A randomised controlled trial (RCT) of 293 patients investigated by TBB with or without EBUS guidance reported a diagnostic yield of 79% (48/61) for malignant lesions and 69% (18/26) for benign lesions in the EBUS–TBB group compared with 55% (46/83) and 44% (16/36) in the TBB-alone group (without EBUS guidance).
2.3.2 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% (57/94) and 78% (69/88) respectively (p = 0.015). Without EBUS guidance, the diagnostic yield was 63% (55/88) for TBNA, 49% (89/182) for TBB (p = 0.049 compared with TBNA) and 20% (36/182) for BW (p < 0.001 compared with TBNA).
2.3.3 An RCT of 120 patients investigated by EBUS–TBB, or electromagnetic navigation bronchoscopy (ENB)–TBB, or a combination of EBUS/ENB–TBB reported diagnostic yields of 69% (27/39), 59% (23/39) and 88% (35/40) respectively (p = 0.02 for comparisons between the groups).
2.3.4 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% (93/140) and 64% (77/121) respectively (significance not stated).
2.3.5 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.
2.4.1 The RCT of 120 patients reported pneumothorax in 5% (2/39) of the EBUS–TBB group, 5% (2/39) of the ENB–TBB group and 8% (3/40) 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.
2.4.2 Pneumothorax was reported in 1% (2/140) of patients in the EBUS–GS transbronchial lung biopsy group compared with 22% (27/121) of patients in the percutaneous CT–FNA group (p < 0.01) in the non-randomised comparative study of 261 procedures.
2.4.3 Pneumothorax was reported in 3% (3/119) 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% (2/88) of patients in the EBUS–TBNA plus TBB plus BW group and 2% (2/94) of patients in the EBUS–TBB plus BW group in the RCT of 202 patients.
2.4.4 The RCT of 293 patients reported bleeding in none of the patients in the EBUS-TBB group compared with 6% (7/119) of patients in the TBB-alone group. The RCT of 202 patients reported bleeding in 5% (4/88) of patients in the EBUS–TBNA plus TBB plus BW group compared with 2% (2/94) of patients in the EBUS–TBB plus BW group.
2.4.5 The Specialist Advisers listed adverse events reported in the literature as pneumothorax and haemorrhage. They listed a theoretical adverse event as false negative rate.