Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy
Primary Purpose
Mediastinal Lymphadenopathy, Sarcoidosis, Pulmonary, Mediastinal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Mediastinal Lymphadenopathy focused on measuring Sarcoidosis, Bronchoscopy, Endobronchial Ultrasound, Intranodal forceps biopsy
Eligibility 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)
Sites / Locations
- The George Washington University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EBUS-TBNA
EBUS-TBNA + EBUS-IFB
Arm Description
These will be the patient who undergo EBUS-TBNA only without EBUS-IFB
These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure
Outcomes
Primary Outcome Measures
Diagnostic Yield
Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone
Secondary Outcome Measures
Duration of Procedure
Duration of combined EBUS-TBNA +IFB procedure compared to TBNA alone
Complications
Complications of EBUS-TBNA +IFB procedure compared to TBNA alone
Full Information
NCT ID
NCT05374447
First Posted
May 10, 2022
Last Updated
October 24, 2023
Sponsor
George Washington University
1. Study Identification
Unique Protocol Identification Number
NCT05374447
Brief Title
Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy
Official Title
Evaluating the Diagnostic Yield and Specimen Quality With Endobronchial Ultrasound-Guided Intranodal Forceps Biopsies in Patients With Mediastinal and Hilar Lymphadenopathy: A Prospective Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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
Oki, M., Saka, H., & Sako, C. (2004). Bronchoscopic miniforceps biopsy for mediastinal nodes. Journal of Bronchology & Interventional Pulmonology, 11(3), 150-153.
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.
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.
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.
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.
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Lymphadenopathy, Sarcoidosis, Pulmonary, Mediastinal Diseases
Keywords
Sarcoidosis, Bronchoscopy, Endobronchial Ultrasound, Intranodal forceps biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization to EBUS-TBNA alone or EBUS-TBNA and EBUS-IFB
Masking
Participant
Masking Description
The participant will be blinded to which group they were randomized to.
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EBUS-TBNA
Arm Type
Active Comparator
Arm Description
These will be the patient who undergo EBUS-TBNA only without EBUS-IFB
Arm Title
EBUS-TBNA + EBUS-IFB
Arm Type
Experimental
Arm Description
These will be the individuals who undergo EBUS-TBNA followed by EBUS-IFB in the same procedure
Intervention Type
Procedure
Intervention Name(s)
Endobronchial Ultrasound-Guided Intranodal Forceps Biopsy
Other Intervention Name(s)
EBUS-IFB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic Yield
Description
Diagnostic yield of EBUS-TBNA + EBUS-IFB compared to EBUS-TBNA alone
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Duration of Procedure
Description
Duration of combined EBUS-TBNA +IFB procedure compared to TBNA alone
Time Frame
1 year
Title
Complications
Description
Complications of EBUS-TBNA +IFB procedure compared to TBNA alone
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khalil Diab, MD
Phone
2027412180
Email
kdiab@mfa.gwu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Delprete, DO
Phone
2027412180
Email
bdelprete@mfa.gwu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mardi Gomberg, MD
Organizational Affiliation
The George Washington University
Official's Role
Study Director
Facility Information:
Facility Name
The George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalil Diab, MD
Phone
2027412180
Email
kdiab@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Delprete, DO
Phone
2027412180
Email
bdelprete@mfa.gwu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Diagnostic Yield of Intranodal Forceps Biopsies in Mediastinal Adenopathy
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