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Comparison of Sono-endoscopic needle aspiration of chest lesions via wind pipe versus food pipe route.

Not Applicable
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
Inclusion Criteria

Patients having subcarinal and paratracheal lymph nodes and lung mass adjacent to mediastinum.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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.
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