Change in Management Following Bronchoscopy in Hematopoietic Stem Cell Transplant Patients With Pulmonary Infiltrates
- Conditions
- Stem Cell Transplant ComplicationsPulmonary Complication
- Interventions
- Procedure: Fiberoptic Bronchoscopy
- Registration Number
- NCT04998903
- Lead Sponsor
- King Faisal Specialist Hospital and Research Centre Madinah
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- All patients who suffered from GVHD following Hematopoietic Stem Cell Transplant and had Pulmonary Infiltrate's requiring Fiberoptic Bronchoscopy.
- Any patients aged less than 14 years.
- Unable to consent
- Those patients who the primary physician decided not have Fiberoptic Bronchoscopy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stem cell transplant with Graft versus host disease Fiberoptic Bronchoscopy Patients who following hematopoietic stem cell transplant suffered from graft versus host disease and presented with pulmonary infiltrates.
- Primary Outcome Measures
Name Time Method Rate of change in clinical decision making following FOB within 1 months of FOB number of patients whose clinical management changed directly as a consequence of fiberoptic bronchoscopy
- Secondary Outcome Measures
Name Time Method Clinical characteristics associated with a positive yield in Fiberoptic Bronchoscopy Within 2 weeks of presentation to FOB clinical characteristics associated with a positive microbiology, virology or cytological yield.
CT scan patterns associated with a positive yield in Fiberoptic Bronchoscopy CT within one month before the FOB clinical characteristics associated with a positive microbiology, virology or cytological yield.
Six month outcome of patients following FOB six months Mortality in the six months following FOB.
Trial Locations
- Locations (1)
King Faisal Specialist Hospital and Research Centre
🇸🇦Riyadh, Saudi Arabia