King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia
NCT Number: NCT04998903
Hematopoietic stem cell transplant (HSCT) is a modality that is increasingly utilized to treat various haematological disorders with a varying degree of success. From 2006 to 2019 use of HSCT worldwide has increased from 50,417 to an estimated 1.5 million. Disease relapse, graft versus host disease (GVHD) and infections are the leading causes of morbidity and mortality in patients with HSCT. Pulmonary complications, in particular, are common in patients with HSCT, and the diagnostic approach and management of these complications remain a challenge. FOB is one of the standard and least invasive diagnostic modality for these patients. However, the diagnostic yield and change in clinical decision making in those studies have been variable. Furthermore, all these studies were retrospective, with one exception.
The investigators designed an observational study to understand the rate of change in clinical decision making following Fiberoptic bronchoscopy (FOB). The investigators also looked at the yield of FOB and characteristics associated with a positive diagnostic yield.
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All sexes
Observational
Riyadh, Saudi Arabia
Hematopoietic stem cell transplant (HSCT) is a modality that is increasingly utilized to treat various hematological disorders with a varying degree of success. From 2006 to 2019 use of HSCT worldwide has increased from 50,417 to an estimated 1.5 million. Disease relapse, graft versus host disease (GVHD) and infections are the leading causes of morbidity and mortality in patients with HSCT. Pulmonary complications, in particular, are common in patients with HSCT, and the diagnostic approach and management of these complications remain a challenge. Reasons for this possibly include a broad spectrum of etiologies, subtle and insidious clinical manifestations, non-specific radiological features, and limited biomarkers. On the other hand, surgical procedures to obtain lung biopsy, which is the ultimate diagnostic tool, are often contraindicated or present high risks to the patients. In this context, less invasive testing such as fiberoptic bronchoscopy (FOB) deserves further consideration. Previous studies showed that the yield of FOB, a low-risk procedure, may provide helpful information in the post HSCT patient with pulmonary infiltrates. However, the diagnostic yield and change in clinical decision making in those studies have been variable. Furthermore, all these studies were retrospective, with one exception.
The stem cell transplant activity in Saudi Arabia has increased exponentially in recent times, with more than 6000 stem cell transplants performed by 2016. Furthermore, the patient population is different regarding specific genetic and immunologic characteristics, underlying disorders and prevalent opportunistic pathogens. Therefore, this study was designed to prospectively evaluate the diagnostic value of FOB in those patients presenting with pulmonary infiltrates.
Study design and Method
This was a retrospective observational study of all patients who had HSCT and pulmonary infiltrates that required bronchoscopy. Data for demographics, clinical presentation, CT scan characteristics, FOB dates and details, microbiology, virology, cytology, histology, change in clinical decision making before and after FOB and 6 months outcome following bronchoscopy were collected.
Primary outcome
Rate of change in clinical decision making following FOB
Secondary outcome
Clinical characteristics associated with a positive yield in FOB CT scan characteristics associated with a positive yield in FOB Six month outcome of patients following FOB.
Statistics
Descriptive statistics for continuous variables were reported as mean ± standard deviation, and categorical variables were summarized as frequencies and percentages. The median and interquartile range (IQR) was used where appropriate.
Continuous variables were compared by independent Student's t-test/ANOVA or non-parametric (Mann Whitney U/Kruskal Wallis) test as appropriate, while categorical variables were compared by Chi-square test. Fisher's exact probability test was applied when examining variables of low incidence. Logistic regression was used to test the association between dependent and independent variables. The level of significance was set at a p-value < 0.05.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fiberoptic bronchoscopy done under conscious sedation
Other names: Broncho-alveolar lavage, Transbronchial biopsy
Time frame: within 1 months of FOB
number of patients whose clinical management changed directly as a consequence of fiberoptic bronchoscopy
Time frame: Within 2 weeks of presentation to FOB
clinical characteristics associated with a positive microbiology, virology or cytological yield.
Time frame: CT within one month before the FOB
clinical characteristics associated with a positive microbiology, virology or cytological yield.
Time frame: six months
Mortality in the six months following FOB.
King Faisal Specialist Hospital & Research Center
Other
Role of Fiberoptic Bronchoscopy in Hematopoietic Stem Cell Transplant Patients With Pulmonary Infiltrates in Changing Management Decisions: An Observational Study
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