Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis
Primary Purpose
Endobronchial Mucosal Pathology in Pulmonary Sarcoidosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bronchoscopic mucosal biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Endobronchial Mucosal Pathology in Pulmonary Sarcoidosis focused on measuring Sarcoidosis - Bronchoscopy - Endobronchial biopsy
Eligibility Criteria
Inclusion Criteria:
- Having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age.
Exclusion Criteria:
- any contraindication for flexible bronchoscopy (e.g. severe refractory hypoxemia, hemodynamic instability, uncorrectable bleeding diathesis, recent myocardial infarction or unstable angina)
Sites / Locations
- Alexandria Medicine Faculty
Outcomes
Primary Outcome Measures
Pathological yield
Histopathological evidence of sarcoidosis in endobronchial mucosal biopsies
Secondary Outcome Measures
Complications
Bleeding, bronchospasm, fever, aspiration, pneumothorax, arrhythmia, hypoxia and cardiac arrest.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04904939
Brief Title
Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis
Official Title
Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria 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
This prospective interventional study was done between May and September 2020. We included 20 patients from the chest department, Alexandria Main University Hospital (AMUH) with the inclusion criteria of having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age. The bronchoscopy procedure was done under local anesthesia. Endobronchial biopsies and bronchoalveolar lavage were obtained.
Detailed Description
This prospective interventional study was done between May and September 2020. We included 20 patients from the chest department, Alexandria Main University Hospital (AMUH) with the inclusion criteria of having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age. The patients who had any contraindication for flexible bronchoscopy (e.g. severe refractory hypoxemia, hemodynamic instability, uncorrectable bleeding diathesis, recent myocardial infarction or unstable angina) were excluded. The study was approved by the institutional ethics committee and an informed consent was taken from all patients before participation in the study according to the guidelines of ethics committee, Alexandria faculty of medicine.
All included patients were subjected to the followings: 1)full history taking including age, sex, history of other diseases and the presenting symptoms, 2)clinical examination including general examination and local chest examination, 3)routine laboratory investigations including complete blood picture, renal function tests, prothrombin activity and international normalized ratio (INR), 4)radiological evaluation including plain x-ray postero-anterior view and CT chest with IV contrast and 5) The bronchoscopy procedure that was performed by two experienced bronchoscopists.
The bronchoscopy procedure was done under local anesthesia with help of sedation by gradual doses of midazolam via the intravenous line. Any abnormal endoscopic findings suggestive of endobronchial sarcoidosis were reported by the operators. Bronchoalveolar lavage (BAL) was obtained by endoscopic injection of at least 120 cc of sterile saline then suction of the whole possible yield. Four endobronchial biopsies were obtained from the described findings plus two other biopsies from the main carina. In absence of mucosal abnormalities, four specimens were taken from a secondary carina and two were taken from the main carina. Immediate and 2 hours' postoperative clinical evaluation was done to detect any possible complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endobronchial Mucosal Pathology in Pulmonary Sarcoidosis
Keywords
Sarcoidosis - Bronchoscopy - Endobronchial biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
The pathologist was blind to bronchoscopic mucosal changes.
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Bronchoscopic mucosal biopsy
Intervention Description
Endobronchial forceps biopsy using flexible bronchoscope
Primary Outcome Measure Information:
Title
Pathological yield
Description
Histopathological evidence of sarcoidosis in endobronchial mucosal biopsies
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Complications
Description
Bleeding, bronchospasm, fever, aspiration, pneumothorax, arrhythmia, hypoxia and cardiac arrest.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age.
Exclusion Criteria:
any contraindication for flexible bronchoscopy (e.g. severe refractory hypoxemia, hemodynamic instability, uncorrectable bleeding diathesis, recent myocardial infarction or unstable angina)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Abdelhady
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria Medicine Faculty
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Study results
Citations:
PubMed Identifier
10430755
Citation
Statement on sarcoidosis. Joint Statement of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) adopted by the ATS Board of Directors and by the ERS Executive Committee, February 1999. Am J Respir Crit Care Med. 1999 Aug;160(2):736-55. doi: 10.1164/ajrccm.160.2.ats4-99. No abstract available.
Results Reference
background
Citation
Abdelhamid MA, Diab HS. The arrhythmic burden in patients with sarcoidosis. Is it a real concern? Egyptian Journal of Chest Diseases and Tuberculosis. 2016;65(1):311-7.
Results Reference
background
PubMed Identifier
17975200
Citation
Prasse A, Katic C, Germann M, Buchwald A, Zissel G, Muller-Quernheim J. Phenotyping sarcoidosis from a pulmonary perspective. Am J Respir Crit Care Med. 2008 Feb 1;177(3):330-6. doi: 10.1164/rccm.200705-742OC. Epub 2007 Nov 1.
Results Reference
background
PubMed Identifier
9306506
Citation
Baughman RP, Winget DB, Bowen EH, Lower EE. Predicting respiratory failure in sarcoidosis patients. Sarcoidosis Vasc Diffuse Lung Dis. 1997 Sep;14(2):154-8.
Results Reference
background
PubMed Identifier
21330454
Citation
Swigris JJ, Olson AL, Huie TJ, Fernandez-Perez ER, Solomon J, Sprunger D, Brown KK. Sarcoidosis-related mortality in the United States from 1988 to 2007. Am J Respir Crit Care Med. 2011 Jun 1;183(11):1524-30. doi: 10.1164/rccm.201010-1679OC. Epub 2011 Feb 17.
Results Reference
background
PubMed Identifier
23397302
Citation
Baughman RP, Nunes H, Sweiss NJ, Lower EE. Established and experimental medical therapy of pulmonary sarcoidosis. Eur Respir J. 2013 Jun;41(6):1424-38. doi: 10.1183/09031936.00060612. Epub 2013 Feb 8.
Results Reference
background
Citation
Mason RJ, Broaddus VC, Martin TR, King TE, Schraufnagel D, Murray JF, et al. Murray and Nadel's Textbook of Respiratory Medicine E-Book: 2-Volume Set: Elsevier Health Sciences; 2010.
Results Reference
background
PubMed Identifier
18539235
Citation
Judson MA. The diagnosis of sarcoidosis. Clin Chest Med. 2008 Sep;29(3):415-27, viii. doi: 10.1016/j.ccm.2008.03.009.
Results Reference
background
PubMed Identifier
9118697
Citation
Torrington KG, Shorr AF, Parker JW. Endobronchial disease and racial differences in pulmonary sarcoidosis. Chest. 1997 Mar;111(3):619-22. doi: 10.1378/chest.111.3.619.
Results Reference
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PubMed Identifier
22417738
Citation
Agarwal R, Srinivasan A, Aggarwal AN, Gupta D. Efficacy and safety of convex probe EBUS-TBNA in sarcoidosis: a systematic review and meta-analysis. Respir Med. 2012 Jun;106(6):883-92. doi: 10.1016/j.rmed.2012.02.014. Epub 2012 Mar 13.
Results Reference
background
Citation
Hewidy AA, Shebl AM. Efficacy and safety of bronchoscopic diagnostic procedures of sarcoidosis: a retrospective study. Egyptian Journal of Chest Diseases and Tuberculosis. 2016;65(2):473-8.
Results Reference
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Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis
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