Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT04904939
Collaborator
(none)
20
1
4.5
4.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bronchoscopic mucosal biopsy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The pathologist was blind to bronchoscopic mucosal changes.
Primary Purpose:
Diagnostic
Official Title:
Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis
Actual Study Start Date :
May 15, 2020
Actual Primary Completion Date :
Sep 1, 2020
Actual Study Completion Date :
Sep 28, 2020

Outcome Measures

Primary Outcome Measures

  1. Pathological yield [7 days]

    Histopathological evidence of sarcoidosis in endobronchial mucosal biopsies

Secondary Outcome Measures

  1. Complications [24 hours]

    Bleeding, bronchospasm, fever, aspiration, pneumothorax, arrhythmia, hypoxia and cardiac arrest.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandria Medicine Faculty Alexandria Egypt

Sponsors and Collaborators

  • Alexandria University

Investigators

  • Principal Investigator: Ahmed M Abdelhady, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Mohamed Abdelhady, Dr. Ahmed Abdelhady, Alexandria University
ClinicalTrials.gov Identifier:
NCT04904939
Other Study ID Numbers:
  • 0106187
First Posted:
May 27, 2021
Last Update Posted:
May 27, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Mohamed Abdelhady, Dr. Ahmed Abdelhady, Alexandria University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2021