Role of Fiberoptic Bronchoscopy in Hematopoietic Stem Cell Transplant Patients With Pulmonary Infiltrates in Changing Management Decisions: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Rate of change in clinical decision making following FOB
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who suffered from GVHD following Hematopoietic Stem Cell Transplant and had Pulmonary Infiltrate's requiring Fiberoptic Bronchoscopy.
排除标准
- •Any patients aged less than 14 years.
- •Unable to consent
- •Those patients who the primary physician decided not have Fiberoptic Bronchoscopy.
结局指标
主要结局
Rate of change in clinical decision making following FOB
时间窗: within 1 months of FOB
number of patients whose clinical management changed directly as a consequence of fiberoptic bronchoscopy
次要结局
- Clinical characteristics associated with a positive yield in Fiberoptic Bronchoscopy(Within 2 weeks of presentation to FOB)
- CT scan patterns associated with a positive yield in Fiberoptic Bronchoscopy(CT within one month before the FOB)
- Six month outcome of patients following FOB(six months)
研究者
Dr Liju Ahmed
Consultant Pulmonologist
King Faisal Specialist Hospital and Research Centre Madinah