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

Comparison of Sono-endoscopic needle aspiration of mediastinal lesions via tracheal (EBUS-TBNA) versus esophageal (EUS- B FNA) route using the same EBUS scope (The SMeLTER Study).â??A Prospective Randomized Control Study - SMeLTER Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021309
Enrollment
126
Registered
2019-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung Health Condition 2: C388- Malignant neoplasm of overlappingsites of heart, mediastinum and pleura Health Condition 3: J99- Respiratory disorders in diseasesclassified elsewhere Health Condition 4: A154- Tuberculosis of intrathoracic lymph nodes

Interventions

Intervention1: EUS-B-FNA(Esophageal Ultrasound Guided Fine Needle Aspiration): Patients who have mediastinal lesions at subcarinal or paratracheal location or mass adjacent to mediastinum measuring at

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1.To assess diagnostic performance between the two groups. 2.Comparison of NAPCOM score between two randomized groups. 3. To compare operator rated satisfaction between the two procedures (VAS) 4. Comparison of patient reported symptoms and patient satisfaction between the two procedure.(VAS) 5. To compare mean dose of topical anaesthetic requirement between the two groups. 6. To measure difference of intravenous analgesic/ sedative requirement between the two groups. Timepoint: During and after 2 hours of procedure.—

Countries

India

Contacts

Public ContactDr Ram Niwas

AIIMS Jodhpur

drrniwas@gmail.com9999493179

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026