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OpenTrials
Completed

NCT Number: NCT04904939

Endobronchial Mucosal Biopsy in Patients With Suspected Pulmonary Sarcoidosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Medicine Faculty

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bronchoscopic mucosal biopsy

Procedure

Endobronchial forceps biopsy using flexible bronchoscope

Primary outcomes

  1. Pathological yield

    Time frame: 7 days

    Histopathological evidence of sarcoidosis in endobronchial mucosal biopsies

Secondary outcomes

  1. Complications

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 27, 2021
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.