Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07459569
Brief Summary:
The goal of this clinical trial is to compare the diagnostic efficacy and safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy (EBUS-TBMC) versus standard EBUS-guided Transbronchial Needle Aspiration (EBUS-TBNA) in adult patients with suspected mediastinal lymph node tuberculosis. The main questions it aims to answer are:
Does EBUS-TBMC provide a superior diagnostic yield for detecting granulomatous inflammation compared to EBUS-TBNA in the same target lymph node? Does the cryopreservation process affect the viability of Mycobacterium tuberculosis for culture, and does the larger tissue sample obtained via EBUS-TBMC enhance the sensitivity of molecular tests such as Xpert MTB/RIF? Is the safety profile of EBUS-TBMC, particularly regarding bleeding complications, comparable to that of EBUS-TBNA in this patient population? Researchers will compare the two biopsy techniques using a paired design within the same patient to see if EBUS-TBMC results in higher rates of positive pathology, microbiology, and molecular diagnoses.
Participants will:
Undergo both EBUS-TBNA and EBUS-TBMC procedures on the same mediastinal lymph node during a single bronchoscopy session, with the order of procedures randomized.
Provide blood and tissue samples for comprehensive testing, including histology, mycobacterial culture, and Xpert MTB/RIF assay.
Complete short-term (within 2 hours post-procedure) and 7-day follow-up assessments to monitor for any adverse events.
Participate in a 6-month clinical follow-up to establish a final diagnosis, which will serve as the reference standard for evaluating the diagnostic tests.
Study:
NCT07459569
Study Brief:
Protocol Section:
NCT07459569