David R. Stather

A Randomized Controlled Trial of Standard vs Endobronchial Ultrasonography-Guided Transbronchial Needle Aspiration in Patients With Suspected Sarcoidosis

BACKGROUND Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) of mediastinal lymph nodes has been found to be more accurate than standard TBNA in the setting of malignancy. In patients with suspected sarcoidosis, the smaller ultrasound needle may yield inadequate material to make a histologic diagnosis of granulomatous inflammation. The aim of this study was to compare the diagnostic yield of EBUS-guided TBNA to TBNA performed with a standard 19-gauge needle in patients with mediastinal adenopathy and a clinical suspicion of sarcoidosis. METHODS A randomized controlled trial was performed in a university medical center, enrolling 50 patients (of 61 screened, 2 declined, and 9 did not meet entry criteria) with hilar and/or mediastinal adenopathy and a clinical suspicion of sarcoidosis. Twenty-four patients were randomized to undergo EBUS-guided TBNA and 26 to undergo TBNA using a standard 19-gauge needle. RESULTS The primary outcome measure of diagnostic yield was 53.8% vs 83.3% in favor of the EBUS-guided TBNA group, an absolute increase of 29.5% (p < 0.05; 95% confidence interval [CI], 8.6 to 55.4%). After blinded research pathology review, diagnostic yield was 73.1% vs 95.8%, in favor of the EBUS-guided TBNA group, an absolute increase of 22.7% (p = 0.05; 95% CI, 1.9 to 42.2%). Sensitivity and specificity were 60.9% and 100%, respectively, in the standard TBNA group, and 83.3% and 100%, respectively, in the EBUS-guided TBNA group (absolute increase in sensitivity, 22.5%; p = 0.085; 95% CI, 3.2 to 44.9%). CONCLUSIONS The diagnostic yield of EBUS-guided TBNA is superior to TBNA using a standard 19-gauge needle for sampling of mediastinal lymph nodes in patients with a clinical suspicion of sarcoidosis. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT00373555.

Evaluation of clinical endobronchial ultrasound skills following clinical versus simulation training.

Background and objective:  Endobronchial ultrasound with transbronchial needle aspiration (EBUS‐TBNA) is a pulmonary procedure that can be challenging to learn. This study aims to compare trainee EBUS‐TBNA performance during clinical procedures, following training with a computer EBUS‐TBNA simulator versus conventional clinical EBUS‐TBNA training.

Assessment and learning curve evaluation of endobronchial ultrasound skills following simulation and clinical training.

Background and objective:  Endobronchial ultrasound is a revolutionary diagnostic pulmonary procedure. The use of a computer endobronchial ultrasound simulator could improve trainee procedural skills before attempting to perform procedures on patients. This study aims to compare endobronchial ultrasound performance following training with simulation versus conventional training using patients.

Validation of an endobronchial ultrasound simulator: differentiating operator skill level.

Background: Endobronchial ultrasound (EBUS) is a revolutionary diagnostic procedure. There is currently no accepted method of assessing EBUS technical skill or competency. Objectives: This study aimed to validate a computer EBUS simulator in differentiating between operators of varying clinical EBUS experience. Methods: A convenience sample (n = 22) of bronchoscopists was separated into four cohorts based on previous bronchoscopy experience: group A = novice bronchoscopists, no EBUS experience (n = 4), group B = expert bronchoscopists, no EBUS experience (n = 5), group C = basic clinical EBUS training (n = 9), group D = EBUS experts (n = 4). After a standardized introduction session on the EBUS simulator, participants performed 2 simulated cases on an EBUS simulator with performance metrics measured by the simulator. Results: Significant differences between groups were noted for total procedure time, percentage of lymph nodes identified and percentage of successful biopsies (p < 0.05, ANOVA). Group D performed significantly better than all other groups for total procedure time and percentage of lymph nodes identified (p < 0.05). Group C performed significantly better than groups A and B for total procedure time, percentage of lymph nodes identified and percentage of successful biopsies (p < 0.05, ANOVA). Conclusions: An EBUS simulator can accurately discriminate between operators with different levels of clinical EBUS experience. EBUS simulators show promise as a tool for assessing training and evaluating competency.

Exercise Capacity, Lung Function, and Quality of Life After Interventional Bronchoscopy

Introduction: Malignant airway obstruction accounts for significant morbidity and mortality in patients with lung and metastatic cancer. We prospectively assessed the effects of bronchoscopic interventions for the treatment of malignant airway obstruction, with specific attention to exercise capacity and quality of life (QoL). Methods: This is a prospective cohort study. Patients with high-grade, symptomatic central malignant airway obstruction were assessed at baseline and then at days 30, 90, and 180 after bronchoscopic intervention with spirometry, 6-minute walk test (6MWT), and QoL and dyspnea questionnaires (European Organization for Research and Treatment of Cancer Quality of Life [C30] and Lung Cancer [LC-13] modules). Results: Thirty-seven patients were included in the final statistical analysis. Increases in 6MWT distance by 99.7 m (95% CI 33.2-166.2 m, p = 0.002), FEV1 by 448 ml (95% CI 203-692 ml, p < 0.001), and FVC by 416 ml (95% CI 130-702 ml, p = 0.003) were seen at day 30 compared with baseline. Clinically and statistically significant improvements were noted in composite dyspnea scores at day 30 by both QoL C30 (decrease of 39.9, 95% CI 21.4-58.4, p < 0.001) and LC-13 (decrease of 28.2, 95% CI 12.9-43.5, p < 0.001) questionnaires. Conclusions: Bronchoscopic intervention for malignant airway obstruction is associated with improvement in 6MWT, spirometry, and dyspnea at 30 days.

The impact of tunneled pleural catheters on the quality of life of patients with malignant pleural effusions.

Background: Tunneled pleural catheters (TPC) are used in the management of malignant pleural effusions (MPE), but the impact of this palliative procedure on patient quality of life (QoL) has not been well described. Objectives: To ascertain the impact of TPCs on symptoms and QoL of patients with recurrent MPE. Methods: Patients with recurrent MPE completed the EORTC QLQ-C30 and LC13 QoL questionnaires at baseline, 2 and 14 weeks; FACIT-TS-G© treatment satisfaction surveys were completed at 14 weeks. Results: A total of 82 patients were recruited. Thirty-seven patients (37/82, 45%) died prior to their 14-week follow-up appointment. Significant improvements in dyspnea at 2 weeks were demonstrated with both dyspnea scores (LC13 baseline score 64.1, 2-week score 43.7, mean change –20.4, n = 56, p < 0.001; C30 baseline score 78.9, 2-week score 46.6, mean change –32.4, n = 68, p < 0.001), as well as with the MRC score (baseline median score 4, 2-week score 3, n = 70, p < 0.001). Global health status/QoL was also significantly improved at 2 weeks (baseline score 34.1, 2-week score 46.3, mean change 12.3, n = 68, p < 0.001). Improvements in cough, fatigue and all functional scales were noted at 2 weeks. The improvements in dyspnea and global health status/QoL were maintained to 14 weeks in surviving subjects and there was further improvement in the MRC score at 14 weeks. Patients who completed the FACIT-TS-G survey demonstrated overall satisfaction with TPC treatment. Conclusions: TPCs are associated with a significant improvement in global health status, QoL and dyspnea at the 2-week time point in patients with recurrent MPE.

Diagnostic utility of peripheral endobronchial ultrasound with electromagnetic navigation bronchoscopy in peripheral lung nodules

This study aimed to investigate the diagnostic utility of peripheral endobronchial ultrasound (pEBUS) followed by as‐needed electromagnetic navigation bronchoscopy (ENB) for sampling peripheral lung nodules.

Trainee impact on advanced diagnostic bronchoscopy: An analysis of 607 consecutive procedures in an interventional pulmonary practice

Background and objective:  Complications during advanced diagnostic bronchoscopy are rare and include: pneumothorax, bleeding, mediastinitis and lymphadenitis. Increased complications have been demonstrated in patients undergoing routine bronchoscopy procedures performed by trainees. This study aimed to determine the impact of trainees during advanced diagnostic bronchoscopy on procedure time, sedation use and complications.

Use of a drug eluting pleural catheter for pleurodesis

ABSTRACT Purpose: Repeated administration of low-dose silver nitrate (SN) has been shown to be effective in creating pleurodesis. This study aimed to determine the effectiveness of a SN-eluting pleural catheter for pleurodesis. Methods: Catheters with a chitosan—SN—hyaluronic acid hydrogel coating designed to release SN over 14 days, or placebo uncoated catheters, were inserted in rabbit and lamb pleurodesis models. Pleurodesis was assessed at 28 days according to a 1–8 point scoring system and pleural fibrosis and inflammation assessed histologically on a 0–4 point scale. Results: In the rabbit model, pleurodesis scores were significantly increased in both the 24 mg and 50 mg SN catheters versus control animals as well as compared to the contralateral untreated pleural space (median-treated side scores were 5, 8, and 1, respectively, median score for contralateral side was 1 in all groups). In the lamb model, pleurodesis scores were significantly increased in both the 750 mg and 1000 mg catheter groups versus control animals as well as compared to the contralateral untreated pleural space (median-treated side scores were 7, 7, and 1, respectively, median score for contralateral pleural space was 1 in all groups). Catheters appeared well tolerated, although higher than expected mortality was seen in the 50 mg catheter rabbit group. Conclusions: A catheter designed to deliver SN to the pleural space over 14 days appears to be effective in creating pleurodesis. Further investigations to determine in-vivo catheter pharmacokinetics, toxicity, dose and optimal coating methods are warranted.

Endobronchial ultrasound learning curve in interventional pulmonary fellows

Little published data exist regarding the learning curve for endobronchial ultrasound‐transbronchial needle aspiration (EBUS‐TBNA). We sought to assess the improvement in skill as trainees learned EBUS‐TBNA in a clinical setting.