Diagnostic Yield & Specimen Adequacy of Flex 19 G vs 22 G EBUS Needle - A Randomized Controlled Trial

NCT05535439 | Completed DMC

• 1 other identifier: EBUS RCT 2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the minimally invasive diagnostic modality for the evaluation of mediastinal and hilar lymph nodes (LNs). Traditionally, EBUS-TBNA is performed using either 21 gauge (G) or 22 G needle with a major limitation of inadequate sample especially when histologic assessment of tissue architecture is necessary such as in lympho-proliferative disorders and granulomatous inflammation. Although the specimen obtained with larger bore 19 G needle has been shown to be superior in terms of more cellular material and ability to subclassify malignant disease, it has more bloody samples. Recently a novel 22 G fine needle biopsy device (EBUS-FNB) has been introduced for endobronchial use after an experience gained from gastroenterology endoscopic ultrasound reporting high yield for core biopsies. FNB device has a unique design with 3 symmetrical, fully formed, cutting heels with 3 angled points to provide acquisition of FNB specimen in the form of a core tissue which might improve the overall diagnostic yield. Herein, investigators will study the diagnostic yield and safety of the 22 G EBUS-FNB needle with 19 G EBUS needle in the evaluation of mediastinal and hilar lymphadenopathy.

Conditions

Mediastinal Lymphadenopathy; Hilar Lymphadenopathy

Keywords

EBUS TBNA; 22 G FNB Device; 19 G Needle; Mediastinal Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

  Defined as the proportion of subjects with a diagnostic EBUS-TBNA specimen if It provided a definitive diagnosis such as malignancy, infection (Tubercular, Fungal), sarcoidosis. Or Diagnosed as Reactive Lymphoid Hyperplasia

  1 Week

Secondary Outcomes (2)

• The proportion of subjects with adequate sample

  1 Week

• Adverse Events

  During or within 24 hours of the procedure

Study Arms (2)

19 G EBUS-TBNA Needle

EXPERIMENTAL

Mediastinal or Hilar Lymphadenopathy will be sampled by using 19 G EBUS-TBNA Needle

Procedure: EBUS-TBNA using 22 G EBUS-FNB Device OR 19 G EBUS-FNA needle

22 G EBUS-FNB Device

EXPERIMENTAL

Mediastinal or Hilar Lymphadenopathy will be sampled by using 22 G EBUS-FNB Device

Procedure: EBUS-TBNA using 22 G EBUS-FNB Device OR 19 G EBUS-FNA needle

Interventions

EBUS-TBNA using 22 G EBUS-FNB Device OR 19 G EBUS-FNA needle PROCEDURE

Both arm will be interventional where mediastinal lymph nodes will be sampled by two typs of needle

19 G EBUS-TBNA Needle; 22 G EBUS-FNB Device

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
• Radiographic features of mediastinal or hilar adenopathy (\>10 mm in any axis)

You may not qualify if:

• Hypoxemic patient (SpO2 \< 92% on fraction of inspired oxygen (FiO2) \>0.3
• Patients receiving anticoagulants or having known bleeding diathesis
• Patients with poor cardiopulmonary reserve or marked hypoxemia at rest
• Accessibility of more convenient site to establish the diagnosis

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Department of Pulmonary Medicine, SGPGIMS

Lucknow, U P, 226014, India

Location

Study Officials

• Ajmal Khan, MD, DM

  SGPGIMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Cytologist and Histopathologist evaluating Diagnostic Yield and Specimen Accuracy will be blinded for type of needle used to minimize the potential of bias
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 15, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 31, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)