Comparing two biopsy methods for diagnosing sarcoidosis
Prospective Randomized Controlled Study Comparing Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients Undergoing Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for Suspected Sarcoidosis
This study is testing which biopsy method, cryobiopsy or forceps biopsy, works better for diagnosing pulmonary sarcoidosis in patients who might have the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sanjay Gandhi Postgraduate Institute of Medical Sciences Government |
| Locations | 1 site (Lucknow, Uttar Pradesh) |
| Trial ID | NCT06853834 on ClinicalTrials.gov |
What this trial studies
This study evaluates the diagnostic yield of endobronchial cryobiopsy versus forceps biopsy in patients suspected of having pulmonary sarcoidosis. A total of 150 patients will be randomized into two groups, with each group undergoing one of the biopsy methods during a routine endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The primary outcome is to determine the proportion of successful diagnoses between the two techniques. Biopsy samples will be processed and analyzed to confirm the presence of non-caseating granulomas characteristic of sarcoidosis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with suspected pulmonary sarcoidosis scheduled for EBUS-TBNA.
Not a fit: Patients with co-morbid conditions or those already receiving treatment for sarcoidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing sarcoidosis, leading to better patient management.
How similar studies have performed: Other studies have shown varying success with different biopsy techniques in diagnosing sarcoidosis, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients of suspected pulmonary sarcoidosis scheduled for routine EBUS-TBNA Exclusion Criteria: 1. Patient age less than 18 years 2. Patients with co-morbid conditions like Diabetes mellitus, renal failure, chronic liver disease or any other chronic disease. 3. Patients already on treatment with steroids or h/o steroids intake in last three months or on disease modifying and immunosuppressive drugs. 4. Final Diagnosis other than sarcoidosis
Where this trial is running
Lucknow, Uttar Pradesh
- Sanjay Gandhi Postgraduate Institute of Medical Sciences — Lucknow, Uttar Pradesh, India (Recruiting)
Study contacts
- Principal investigator: Ajmal Khan, MBBS, MD, DM — Sgpgims
- Study coordinator: Ajmal Khan, MBBS, MD, DM
- Email: drajmal13@gmail.com
- Phone: +919878678689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.