Predictive Value of Endobronchial Ultrasound Strain Elastography in Mediastinal Lymph Node Staging: The E-Predict Multicenter Study Results.

BACKGROUND: Systematic assessment of lymph node status by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is indicated in (suspected) lung cancer. Sampling is herein guided by nodal size and FDG-PET characteristics. Ultrasound strain elastography (SE) might further improve risk stratification. By imaging tissue deformation over time, SE computes relative tissue strain. In several tissues, a lower strain (deformation) has been associated with a higher likelihood of malignancy. OBJECTIVES: To assess if EBUS-SE can independently help predict malignancy, and when combined with size and FDG uptake information. METHODS: This multicenter (n = 5 centers) prospective trial included patients with suspected or proven lung cancer using a standardized measurement protocol. Cytopathology combined with surgery or follow-up imaging (>6 months) were used as reference standard. RESULTS: Between June 2016 and July 2018, 327 patients and 525 lymph nodes were included (mean size 12.3 mm, malignancy prevalence 0.48). EBUS-SE had an overall AUC of 0.77. A mean strain <115 (range 0-255) showed 90% sensitivity, 43% specificity, 60% positive predictive value, and 82% negative predictive value. Combining EBUS-SE (<115) with size (<8 mm) and FDG-PET information into a risk stratification algorithm increased the accuracy. Combining size and SE showed that the 48% a priori chance of malignancy changed to 11 and 70% in double negative or positive nodes, respectively. In the subset where FDG-PET was available (n = 370), triple negative and positive nodes went from a 42% a priori chance of malignancy to 9 and 73%, respectively. CONCLUSIONS: EBUS-SE can help predict lymph node malignancy and may be useful for risk stratification when combined with size and PET information.

Image enhancement technology in bronchoscopy: a prospective multicentre study in lung cancer.

INTRODUCTION: Patients with lung cancer may present with additional lesions in the central airways. Earlier studies have shown a relationship between vessel diameter, pattern and grade of malignancy. High-definition (HD+) bronchoscopy with image enhancement techniques (i-scan) detected more vascular abnormalities but correlation with pathology has not yet been established. METHODS: In this investigator-initiated, randomised, controlled, crossover, multicentre study in patients with suspected lung cancer, a HD+ bronchoscopy was performed with i-scan1 and i-scan2 settings in random order. Biopsies, visual grade and vascular pattern classification were obtained by endoscopists and blinded evaluation. RESULTS: In 107 patients, vascular patterns were classified in 48 tumours. Abrupt-ending vessels were predominantly found in squamous cell carcinoma but overall correlation between vessel pattern and histology was not significant (p=0.339). Additional lesions were detected in 35 patients (33%) with a correlation between vessel pattern and high-grade (pre-)invasive lesions (p<0.001). In 8.4% of the patients, relevant second lesions were detected which determined treatment and staging in 3% of all patients. Interobserver agreement was excellent for visual grading of the airway epithelium, but low for classifying vascular patterns. No significant detection rate difference was found by blinded and unblinded evaluation. CONCLUSION: HD+ bronchoscopy with i-scan image enhancement readily detects additional lesions. In one-third of all the patients, additional lesions were detected. Their vascular pattern correlates to pathology outcome, but the interobserver correlation for vascular pattern classification is low. These lesions were relevant in 8.4% and affected treatment and work-up in 3% of the cases. TRIAL REGISTRATION NUMBER: NCT02285426; Results.

The bacterial lysate Lantigen B reduces the number of acute episodes in patients with recurrent infections of the respiratory tract: the results of a double blind, placebo controlled, multicenter clinical trial.

Studies in the 1970s and 1980s reported that bacterial lysates (BL) had a prophylactic effect on recurrent respiratory tract infections (RRTI). However, controlled clinical study procedures have evolved substantially since then. We performed a trial using updated methods to evaluate the efficacy of Lantigen B®, a chemical BL. This double blind, placebo controlled, multi-center clinical trial had the primary objective of assessing the capacity of Lantigen B to significantly reduce the total number of infectious episodes in patients with RRTI. Secondary aims were the RRTI duration, the frequency and the severity of the acute episodes, the use of drugs and the number of missed workdays. In the subgroup of allergic patients with RRTI, the number of allergic episodes (AE) and the use of anti-allergic drugs were also evaluated. One hundred and sixty patients, 79 allocated to the treated group (TG) and 81 to the placebo group (PG), were enrolled; 30 were lost during the study and 120 (79 females and 38 males) were evaluated. The PG had 1.43 episodes in the 8-months of follow-up while the TG had 0.86 episodes (p=0.036). A similar result was observed in the allergic patients (1.80 and 0.86 episodes for the PG and the TG, respectively, p=0.047). The use of antibiotics was reduced (mean 1.24 and 2.83 days of treatment for the TG and the PG). Logistic regression analysis indicated that the estimated risk of needing antibiotics and NSAIDs was reduced by 52.1 and 30.6%, respectively. With regard to the number of AE, no significant difference was observed between the two groups, but bronchodilators, antihistamines and local corticosteroids were reduced by 25.7%, 56.2% and 41.6%, respectively, in the TG. Lantigen B significantly reduced the number of infectious episodes in patients with RRTI. This finding suggests a first line use of this drug for the prophylaxis of infectious episodes in these patients.