Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06853834

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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)

Long-term Monitoring

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

Loading map...

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

Similar Trials

A Seamless Phase 1b/2 Multiple Dose Study of XTMAB-16 in Pat...

Pulmonary Sarcoidosis

Actively Recruiting

34 locations

Efficacy and Safety of OATD-01 Compared to Placebo in Adults...

Pulmonary Sarcoidosis

Actively Recruiting

28 locations

Role of Genetic Factors in the Pathogenesis of Lung Disease

Cystic Fibrosis

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here