Actively Recruiting
Comparative Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients Undergoing Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Suspected Sarcoidosis
Led by Sanjay Gandhi Postgraduate Institute of Medical Sciences · Updated on 2025-03-03
150
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sarcoidosis is a disease that affects multiple organs, mainly the lungs and lymph nodes, causing granulomas or small clusters of immune cells. This research compares two methods of taking tissue samples from the airways in patients suspected of having sarcoidosis. The study aims to determine which biopsy method, cryo-endobronchial biopsy or forceps biopsy, provides better diagnostic information when combined with standard lymph node sampling. The study will enroll 150 patients suspected of pulmonary sarcoidosis, randomly assigning them to receive either cryo-endobronchial biopsy or forceps biopsy after routine endobronchial ultrasound-guided lymph node sampling. Each patient will have biopsies taken from specific airway locations regardless of visible abnormalities, with additional samples from abnormal areas if found. Tissue samples will be prepared and analyzed by a pathologist who will not know which biopsy method was used. Participants will undergo bronchoscopy and biopsy procedures, followed by laboratory tests to assess the quality and diagnostic value of the tissue samples. Researchers will measure the diagnostic yield of each biopsy method and the combined yield with lymph node sampling. Safety and any complications will also be tracked from enrollment until two weeks after the last patient is enrolled. The study will help determine the best way to obtain airway tissue samples for diagnosing sarcoidosis.
CONDITIONS
Brief Title
Comparative Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients With Suspected Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients suspected of pulmonary sarcoidosis scheduled for routine endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
- Age 18 years or older
You will not qualify if you...
- Age less than 18 years
- Presence of chronic diseases such as diabetes mellitus, renal failure, chronic liver disease, or other chronic illnesses
- Current or recent (within last 3 months) treatment with steroids or immunosuppressive drugs
- Final diagnosis other than sarcoidosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day procedure
Participants undergo routine endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) followed by endobronchial biopsy using either a cryo-probe or standard bronchoscopic forceps.
1 visit (in-person)
Duration - Up to 2 weeks after enrollment
Participants are monitored for diagnostic outcomes and any complications following the biopsy procedure.
Follow-up assessments within 2 weeks after procedure
Trial Site Locations
Total: 1 location
1
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014
Actively Recruiting
Research Team
A
Ajmal Khan, MBBS, MD, DM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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