An RCT of 19G EBUS-TBNA Needle in Suspected Sarcoidosis (GUESS)

A Study Evaluating the Diagnostic Yield and Safety of the 19-GaUge vs 22-Gauge EBUS-TBNA Needle in Subjects With Suspected Sarcoidosis (GUESS)

Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. In the presence of intrathoracic lymph nodes, transbronchial needle aspiration (TBNA) is a useful diagnostic modality, which is now guided using endobronchial ultrasound (EBUS).

We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.

Study Overview

• Status: Completed
• Conditions: Sarcoidosis
• Intervention / Treatment: Device: 19 gauge needle; Device: 22 gauge needle

Detailed Description

Sarcoidosis is an idiopathic disorder characterized by granulomatous inflammation involving various organ systems. The disease is diagnosed based on a suggestive clinicoradiological picture and the presence of non-caseating granulomas in the involved organ, after excluding known causes of granulomatous inflammation. The lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis. Various bronchoscopic techniques such as endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are commonly used for acquiring tissue samples.

In the presence of intrathoracic lymph nodes, TBNA is a useful diagnostic modality, especially when combined with endobronchial and transbronchial biopsies. At most centers, TBNA is now guided using endobronchial ultrasound (EBUS). The technique is minimally invasive and also offers the advantage of a selection of the appropriate node for sampling based on the ultrasonographic characteristics. Several studies have demonstrated the superiority of EBUS-TBNA over conventional TBNA (TBNA performed without real-time guidance).

Several technical aspects of EBUS-TBNA have been studied to optimize the yield including the number of aspirations or passes required per lymph node station, needle gauge (21 vs. 22 gauge), suction pressure, the distance travelled by the needle within the lymph node, the number of needle agitations required during a pass, and others.

The novel 19-G Vizishot FLEX EBUS needle (Olympus) is composed of a more flexible material (nitinol) than the 22-G EBUS needle. This allows it to have a larger inner diameter with the same outer diameter as a 22-G EBUS needle. Recent studies have shown that the 19-G needle is safe and has a comparable yield to smaller bore needles. In case of suspected lymphadenopathy due to malignant disorders, aspiration using smaller gauge needles may yield sufficient material for diagnosis. However, in sarcoidosis, larger nodal tissue obtained with a thicker bore needle, the 19-gauge needle, may potentially increase the identification of granulomas. We hypothesize that the 19-gauge EBUS-TBNA needle will have a higher yield as compared to the conventional 22-gauge EBUS-TBNA needle in intrathoracic lymphadenopathy due to sarcoidosis. In this study, we plan to evaluate the yield and safety of the 19-gauge needle vs. the conventional 22-gauge EBUS-TBNA needle in patients with sarcoidosis.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sahajal Dhooria, MD, DM; Phone Number: 7087002015; Email: sahajal@gmail.com
• Study Contact Backup: Name: Ritesh Agarwal, MD, DM; Phone Number: 7087007625; Email: riteshpgi@gmail.com

Study Locations

• India
  • Chandigarh, India, 160012
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: All the following

• Age at least 18 years
• Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
• Enlarged bilateral hilar and/or mediastinal lymph nodes >10 mm (any axis) on computed tomography of the chest
• Ability to provide informed consent to participate in the study.

Exclusion Criteria: Patients with any of the following will be excluded

• Asymmetric lymph nodes
• Lymph nodes with significant hypodense areas suggestive of necrosis
• Tuberculin skin test >10 mm
• Hypoxemia (SpO2 <92% on FiO2 of 0.3)
• Treatment with systemic glucocorticoids for >2 weeks in the preceding three months
• Diagnosis of sarcoidosis possible with another minimally invasive technique such as skin biopsy or peripheral lymph node biopsy
• Failure to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 19G; 19 gauge EBUS-TBNA needle	Device: 19 gauge needle; EBUS-TBNA performed using 19G needle
Active Comparator: 22G; 22 gauge EBUS-TBNA needle	Device: 22 gauge needle; EBUS-TBNA performed using 22G needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield of EBUS-TBNA samples	Specimen showing epithelioid cell granulomas or collection of epithelioid cells with a giant cell (or asteroid body or Schaumann body).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of EBUS-TBNA samples	Specimen shows a preponderance of lymphocytes or is diagnostic	7 days
Complication rate	Complication associated with EBUS-TBNA procedure	7 days
Cough visual analog scale (VAS)	Operator-rated visual analog scale (VAS) score for the intensity of subject's cough	1 day
Operator VAS	VAS score for ease of performance of the needle puncture and aspiration rated by the operator	1 day

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Collaborators: All India Institute of Medical Sciences, New Delhi; Rajiv Gandhi Cancer Institute & Research Center, India; Apollo Hospitals Enterprise Limited; Asian Institute of Gastroenterology, Hyderabad; Jaipur Golden Hospital, New Delhi; Institute of Pulmonology, Medical Research, and Development, Mumbai; Yashoda Hospitals, Hyderabad; City Clinic and Bhailal Amin General Hospital, Vadodara; All India Institute of Medical Sciences, Bhopal

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hypersensitivity; Hypersensitivity, Delayed; Sarcoidosis
• Other Study ID Numbers: SPL822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No