Clinical trial NCT04904939: Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis
Official title: Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endobronchial Mucosal Pathology in Pulmonary Sarcoidosis
Keywords: Sarcoidosis - Bronchoscopy - Endobronchial biopsy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Pathological yield
timeFrame: 7 days
Secondary outcomes:
measure: Complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Medicine Faculty
Study officials:
affiliation: Alexandria University
name: Ahmed M Abdelhady
role: PRINCIPAL_INVESTIGATOR
References:
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