Learn about Research & Clinical Trials

Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy

Study Purpose

The investigators will compare endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) with intranodal forceps biopsy (EBUS-IFB) as it relates to the rate of diagnosis of suspected sarcoidosis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Radiologic evidence of mediastinal and/or hilar lymphadenopathy.
  • - Attending radiologist or pulmonologist reports a possible diagnosis of sarcoidosis.
  • - Age 18 years or older.
Exclusion Criteria*: These are the characteristics that a participant must NOT have in order to be eligible to participate in the study. Order Number Criteria.
  • - Severe pulmonary hypertension.
  • - Inability to undergo general anesthesia.
  • - Severe coagulopathy or bleeding diathesis.
  • - Previously diagnosed sarcoidosis.
  • - Patient presently taking clopidogrel.
  • - Patient deemed to be high risk for general anesthesia per anesthesiologist.
  • - Hemodynamic instability.
  • - Mediastinitis.
- Acute Hypercarbic Respiratory Failure (pCO2 >55mmHg)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05374447
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

George Washington University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mardi Gomberg, MD
Principal Investigator Affiliation The George Washington University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Mediastinal Lymphadenopathy, Sarcoidosis, Pulmonary, Mediastinal Diseases
Additional Details

This is prospective, single center randomized comparative study to determine the diagnostic yield and specimen quality of endobronchial ultrasound guided intranodal forceps biopsy of patients with suspected sarcoidosis based solely on imaging. This will be a single group study and will compare transbronchial needle aspiration via 19 or 21-gauge needle with intranodal forceps biopsy. The study aims to answer a knowledge gap a as to whether the diagnostic yield and specimen quality of EBUS-TBNA with a 19G needle is less than those obtained by 1.9mm or greater intranodal forceps biopsy. The study proposed here will add to the field by further elucidating whether this procedure is beneficial for the diagnosis as it pertains to suspected sarcoidosis. The anticipated required enrollment is 55 patients to achieve an α of 0.05 and β of 0.2. This assumes an unassisted diagnostic yield of 62.5% with standard of care EBUS-TBNA as reported in Ray et al, and a diagnostic supplementation to 80% yield with intranodal forceps biopsies. References. 1. Oki, M., Saka, H., & Sako, C. (2004). Bronchoscopic miniforceps biopsy for mediastinal nodes. Journal of Bronchology & Interventional Pulmonology, 11(3), 150-153. 2. Herth FJ, Morgan RK, Eberhardt R, Ernst A. Endobronchial ultrasound-guided miniforceps biopsy in the biopsy of subcarinal masses in patients with low likelihood of non-small cell lung cancer. Ann Thorac Surg. 2008 Jun; 85(6):1874-8. 3. Chrissian A, Misselhorn D, Chen A. Endobronchial-ultrasound guided miniforceps biopsy of mediastinal and hilar lesions. The Annals of Thoracic Surgery. 2011;92(1):284-288. 4. Franke KJ, Bruckner C, Szyrach M, Ruhle KH, Nilius G, Theegarten D. The contribution of endobronchial ultrasound-guided forceps biopsy in the diagnostic workup of unexplained mediastinal and hilar lymphadenopathy. Lung. 2012;190(2):227-232. 5. Herth FJF, Schuler H, Gompelmann D, et al. Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study. European Respiratory Journal. 2012;39(2):373-377. 6. Darwiche K, Freitag L, Nair A, et al. Evaluation of a novel endobronchial ultrasound-guided lymph node forceps in enlarged mediastinal lymph nodes. Respiration. 2013;86(3):229-236. 7. Ray AS, Li C, Murphy TE, et al. Improved diagnostic yield and specimen quality with endobronchial ultrasound-guided forceps biopsies: a retrospective analysis. The Annals of Thoracic Surgery. 2020;109(3):894-901

Arms & Interventions

Arms

Active Comparator: EBUS-TBNA

These will be the patient who undergo EBUS-TBNA only without EBUS-IFB

Experimental: EBUS-TBNA + EBUS-IFB

These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure

Interventions

Procedure: - Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy

Patients with mediastinal adenopathy will undergo EBUS-IFB and EBUS-TBNA during the same procedure to compare the yield of this procedure with EBUS-TBNA alone.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington, District of Columbia

Status

Recruiting

Address

The George Washington University Hospital

Washington, District of Columbia, 20037

Site Contact

Khalil Diab, MD

kdiab@mfa.gwu.edu

2027412180