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

NCT05535439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-09-11

No results posted yet for this study

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

Interventions

PROCEDURE

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

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

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Ajmal Khan, MD, DM · SGPGIMS

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2023-08-30
Completion
2023-08-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05535439 on ClinicalTrials.gov