NCT06853834 Comparative Diagnostic Yield of Endobronchial Cryo Biopsy vs Forceps Biopsy in Patients With Suspected Sarcoidosis
| NCT ID | NCT06853834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Condition | Sarcoidosis Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-04-15 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-01-01 with a primary completion date of 2025-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sarcoidosis is a multi-systemic granulomatous disease of unknown cause that is characterized by the formation of non-caseous epithelioid cell granulomas. Sarcoidosis involves the respiratory system in \> 90% of cases, usually the hilar and mediastinal nodes, and, less frequently, the lung tissue. Airway involvement, as judged by clinical features, physiologic testing, imaging techniques, bronchoscopy, and airway mucosal biopsy, has been observed in nearly two-thirds of patients with sarcoidosis. Although sarcoidosis involving thoracic lymph nodes and pulmonary parenchyma is familiar to most clinicians, airway involvement is often overlooked. The frequency of airway involvement increases as the parenchymal disease progresses, and\\airway involvement is associated with increased morbidity, respiratory symptoms, and mortality. The initial airway abnormality is the inflammation manifested by mucosal edema, erythema, and the formation of granulomas. As the airway disease progresses, the mucosa may demonstrate granularity, nodularity, cobble stoning, and friability. Sarcoid granulomas tend to develop along the bronchovascular bundle or in the vicinity of the airways. Overall quality of the endobronchial biopsy (EBB) will depend on the method by which it is obtained and cryo-EBB will most likely to provide better tissue for the diagnosis in comparison to forceps biopsy which has smaller sample as well as crush artifacts. Therefore, it is hypothesized that cryo-EBB will be better than forceps EBB and combined together it will increase the overall diagnostic yield of the sarcoidosis when combined with lymph node sampling by endobronchial ultrasound guided trans-bronchial needle aspiration (EBUS-TBNA). 1. Primary objective: To compare the diagnostic yield of cryo-EBB with forceps biopsy in patients undergoing routine EBUS-TBNA for suspected sarcoidosis. 2. Secondary Objective: To evaluate the overall diagnostic yield of combined endobronchial biopsy and EBUS-TBNA in patients undergoing routine EBUS-TBNA for suspected sarcoidosis. The relevance and the expected outcome of the proposed study 1. The study will provide insight to obtain an endobronchial biopsy either with cryo probe or forceps 2. The study will also provide information regarding overall increase in diagnostic yield if any when the endobronchial biopsies are combined with EBUS-TBNA.
Eligibility 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
Contact & Investigator
Ajmal Khan, MBBS, MD, DM
PRINCIPAL INVESTIGATOR
SGPGIMS
Frequently Asked Questions
Who can join the NCT06853834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcoidosis Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06853834 currently recruiting?
Yes, NCT06853834 is actively recruiting participants. Contact the research team at drajmal13@gmail.com for enrollment information.
Where is the NCT06853834 trial being conducted?
This trial is being conducted at Lucknow, India.
Who is sponsoring the NCT06853834 clinical trial?
NCT06853834 is sponsored by Sanjay Gandhi Postgraduate Institute of Medical Sciences. The principal investigator is Ajmal Khan, MBBS, MD, DM at SGPGIMS. The trial plans to enroll 150 participants.