Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis

Not Applicable

Completed

• Conditions: Endobronchial Mucosal Pathology in Pulmonary Sarcoidosis

• Registration Number: NCT04904939
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2020-05-15
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-28
• Status Verified: 2021-05
• Study First Submitted: 2021-05-23
• Study First Submitted QC: 2021-05-23
• Last Update Submitted: 2021-05-23
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathological yield	7 days	Histopathological evidence of sarcoidosis in endobronchial mucosal biopsies

Secondary Outcome Measures

Name	Time	Method
Complications	24 hours	Bleeding, bronchospasm, fever, aspiration, pneumothorax, arrhythmia, hypoxia and cardiac arrest.

Trial Locations

Locations (1)

Alexandria Medicine Faculty; 🇪🇬 Alexandria, Egypt