View clinical trials related to Mediastinum.
Filter by:Therefore, a high number of procedures is necessary to achieve EUS competency, but interobserver agreement still varies widely. Artificial intelligence (AI) aided recognition of anatomical structures may improve the training process and inter-observer agreement. Robles-Medranda et al. developed an AI model that recognizes normal anatomical structures during linear and radial EUS evaluations. We pursue to design an external validation of our developed AI model, considering an endoscopist expert as the gold standard.
The study will include 30 patients with hilar/mediastinal lymph nodes detected by thoracic CT either there was a known lung malignancy (for staging purpose) or not (for diagnosing purpose). All patients will undergo to EBUS-guided TBNA. Elastography will be performed on all lymph nodes that will be candidates for EBUS TBNA. Mediastinoscopy or other invasive procedures will be performed if EBUS-guided TBNA doesn't provide representative material.
Endobronchial Ultrasound Guided Transbronchial Needle aspiration (EBUS-TBNA) is a firmly established modality for diagnostic evaluation of mediastinal lesions. The procedure is routinely performed at the Department of Pulmonary Medicine and Sleep Disorders, AIIMS, New Delhi since 2012. Transesophageal approach for fine needle aspiration of mediastinal lesions using the Endobronchial Ultrasound (EBUS) scope [also described as Transesophageal Bronchoscopic Ultrasound Guided Fine Needle aspiration (EUS-B-FNA)] (also routinely performed in the department) and has been described as a safe and efficacious modality. EUS-B-FNA is usually employed when EBUS-TBNA is not feasible or excessive cough or secretions necessitate switch to esophageal route. We hypothesize that EUS-B-FNA as the primary approach has similar diagnostic performance as EBUS-TBNA and is associated with greater patient and operator rated procedure comfort and lesser requirement of anaesthesia medications for evaluation of patients with mediastinal lesions easily accessible with either of the two approaches. We propose to undertake a prospective randomized comparison of Transesophageal (EUS-B-FNA) versus Transtracheal (EBUS-TBNA) approach for fine needle aspiration using the same EBUS scope in patients referred for endo-sonographic evaluation of mediastinal lesions. A total of 100 serial patients (with Subcarinal and/or Lower Left paratracheal located mediastinal lymphadenopathy at least >1cm in Short axis diameter) shall be included. After consent and preliminary investigations, patients shall be randomized equally into the two approaches. Procedure will be performed under local anaesthesia (topical lignocaine) and i.v. sedation (midazolam and fentanyl) in the bronchoscopy laboratory. The primary objective will be comparison of proportion of diagnostic and adequate aspirates in the two groups. Secondary objectives will include operator rated cough (VAS), Operator rated overall procedure satisfaction (VAS), dose of midazolam and fentanyl administered, lignocaine dose and total procedure duration.The primary data analysis shall be for the performance characteristics of the primary approach. All the aspirates shall be analysed by the same pathologist for final interpretation.
This prospective study will include 30 patients with hilar/mediastinal lymph nodes detected by thoracic CT either there was a known lung malignancy (for staging purpose) or not (for diagnosing purpose). All patients will undergo to ROSE during EBUS-guided TBNA. Mediastinoscopy or other invasive procedures will be performed if EBUS-guided TBNA doesn't provide representative material.