A clinical trial comparing the diagnostic yield of EBUS-TBNA using different number of needle passes through the mediastinal lymph nodes in patients having mediastinal lymphadenopathy.
Not Applicable
- Conditions
- Health Condition 1: J985- Diseases of mediastinum, not elsewhere classified
- Registration Number
- CTRI/2023/02/049627
- Lead Sponsor
- Randeep Singh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Consenting subjects between 18 and 75 years of age.
2.Subjects with mediastinal lymphadenopathy scheduled for EBUS-TBNA as part of clinical care.
3.Enlarged ( >10 mm in short axis) intrathoracic lymph nodes seen on computed tomography (CT) /PET CT of the chest.
Exclusion Criteria
1.Contra-indications to EBUS(coagulopathy, anticoagulation, thrombocytopenia, other bleeding diatheses).
2.Pregnant females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the diagnostic yield of EBUS-TBNA using different numbers of lymph node agitations (10-15 vs 15-20 vs 20-25) in patients with mediastinal lymphadenopathy.Timepoint: 8 week
- Secondary Outcome Measures
Name Time Method 1.To compare the diagnostic yield of EBUS-TBNA using 10-15 versus 15-20 versus 20-25 lymph node agitations in patients with malignant mediastinal lymph node involvement. <br/ ><br> <br/ ><br>2.To estimate the rate of adverse events (bleeding, pneumothorax, hypoxemia, mediastinitis) in patients of mediastinal lymphadenopathy undergoing different number of agitations (10-15 vs 15-20 vs 20-25) per lymph node pass. <br/ ><br> <br/ ><br>3.To compare the specimen adequacy using different numbers of agitations (10-15 vs 15-20 vs 20-25) for immunohistochemical/molecular analysis. <br/ ><br>Timepoint: 8 week