Comparison of Sono-endoscopic needle aspiration of chest lesions via wind pipe versus food pipe route.
- Conditions
- Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lungHealth Condition 2: C388- Malignant neoplasm of overlappingsites of heart, mediastinum and pleuraHealth Condition 3: J99- Respiratory disorders in diseasesclassified elsewhereHealth Condition 4: A154- Tuberculosis of intrathoracic lymph nodes
- Registration Number
- CTRI/2019/09/021309
- Lead Sponsor
- AIIMS Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients having subcarinal and paratracheal lymph nodes and lung mass adjacent to mediastinum.
1.Refusal of consent for the procedure
2.Any contraindications to bronchoscopy ,endobronchial ultrasound and esophageal endoscopy like uncooperative patient, refractory hypoxemia, unstable cardiaovascular status, recent/unstable angina, myocardial infarction within last 6 weeks, arrhythmias, bleeding disorders, uremia, suspected esophageal perforation, etc will be excluded from the study.
3.Patients who will need to undergo other concurrent bronchoscopic procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare patient and operator reported adverse events related to procedure between EBUS-TBNA versus EUS-B-FNA in the two randomised groups.Timepoint: During and after 2 hours of procedure.
- Secondary Outcome Measures
Name Time Method 1.To assess diagnostic performance between the two groups. <br/ ><br>2.Comparison of NAPCOM score between two randomized groups. <br/ ><br>3.To compare operator rated satisfaction between the two procedures (VAS) <br/ ><br>4.Comparison of patient reported symptoms and patient satisfaction between the two procedure.(VAS) <br/ ><br>5.To compare mean dose of topical anaesthetic requirement between the two groups. <br/ ><br>6.To measure difference of intravenous analgesic/ sedative requirement between the two groups. <br/ ><br>Timepoint: During and after 2 hours of procedure.