EBUS-TBNA vs EUS-B-FNA for Needle Aspiration of Mediastinal Lesions

NCT02704078 | Completed DMC

• 1 other identifier: IEC/NP-419/09.10.2015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Endobronchial Ultrasound Guided Transbronchial Needle aspiration (EBUS-TBNA) is a firmly established modality for diagnostic evaluation of mediastinal lesions. The procedure is routinely performed at the Department of Pulmonary Medicine and Sleep Disorders, AIIMS, New Delhi since 2012. Transesophageal approach for fine needle aspiration of mediastinal lesions using the Endobronchial Ultrasound (EBUS) scope \[also described as Transesophageal Bronchoscopic Ultrasound Guided Fine Needle aspiration (EUS-B-FNA)\] (also routinely performed in the department) and has been described as a safe and efficacious modality. EUS-B-FNA is usually employed when EBUS-TBNA is not feasible or excessive cough or secretions necessitate switch to esophageal route. We hypothesize that EUS-B-FNA as the primary approach has similar diagnostic performance as EBUS-TBNA and is associated with greater patient and operator rated procedure comfort and lesser requirement of anaesthesia medications for evaluation of patients with mediastinal lesions easily accessible with either of the two approaches. We propose to undertake a prospective randomized comparison of Transesophageal (EUS-B-FNA) versus Transtracheal (EBUS-TBNA) approach for fine needle aspiration using the same EBUS scope in patients referred for endo-sonographic evaluation of mediastinal lesions. A total of 100 serial patients (with Subcarinal and/or Lower Left paratracheal located mediastinal lymphadenopathy at least \>1cm in Short axis diameter) shall be included. After consent and preliminary investigations, patients shall be randomized equally into the two approaches. Procedure will be performed under local anaesthesia (topical lignocaine) and i.v. sedation (midazolam and fentanyl) in the bronchoscopy laboratory. The primary objective will be comparison of proportion of diagnostic and adequate aspirates in the two groups. Secondary objectives will include operator rated cough (VAS), Operator rated overall procedure satisfaction (VAS), dose of midazolam and fentanyl administered, lignocaine dose and total procedure duration.The primary data analysis shall be for the performance characteristics of the primary approach. All the aspirates shall be analysed by the same pathologist for final interpretation.

Conditions

Mediastinum

Outcome Measures

Primary Outcomes (1)

• Diagnostic Sensitivity of EUS-B-FNA versus EBUS-TBNA

  The diagnostic yield of EBUS-TBNA shall be compared with EUS-B-FNA ie comparison of the proportion of diagnostic aspirates between the EBUS-TBNA and the EUS-B-FNA groups

  At study completion at approximately 18 months

Secondary Outcomes (5)

• Topical Anaesthetic requirement between the two groups

  Comparing the mean doses of lignocaime administered in mg between the study participants in two groups at study completion at approximately 18 months

• Intravenous Sedative / analgesic requirement between the two groups

  Compating the mean doses of sedative administered in mg between the study participants in two groups at study completion at approximately 18 months

• Operator rated overall procedure satisfaction (VAS)

  At study completion at approximately 18 months

• Operator rated cough between the two procedures (VAS)

  At study completion at approximately 18 months

• Overall duration of procedure

  Intraoperative

Study Arms (2)

EBUS-TBNA

ACTIVE COMPARATOR

Mediastinal lymph node aspiration shall be performed transtracheally.

Device: EBUS-TBNA

EUS-B-FNA

EXPERIMENTAL

Mediastinal lymph node aspiration shall be performed transesophageally

Device: EUS-B-FNA

Interventions

EBUS-TBNA DEVICE

EBUS-TBNA - Patients in the Active comparator arm shall undergo mediastinal lymph node aspiration transtracheally using the EBUS scope

EBUS-TBNA

EUS-B-FNA DEVICE

EUS-B-FNA - Patients in the experimental arm EUS-B-FNA shall undergo mediastinal lymph node aspiration transesophageally using the EBUS scope

EUS-B-FNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and Older
• Predominant Subcarinal or Lower Left paratracheal located mediastinal lymphadenopathy/mediastinal lesions at least \>1cm in Short axis diameter.
• Patients who give consent

You may not qualify if:

• Refusal of consent for the procedure
• Any contraindications to Bronchoscopy / Endobronchial Ultrasound
• Pregnancy

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

Study Officials

• Randeep Guleria

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary MedicIne and Sleep Disorders

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 9, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

IN (1)