Bed-side Ultrasound in the Evaluation of Gastro-intestinal Tract and Neutropenic Enterocolitis (NEC) in Neutropenic Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,740
- 试验地点
- 1
- 主要终点
- to correlate patient's symptoms with outcome
研究概览
简要总结
Neutropenic enterocolitis (NEC) is a life-threatening complication of leukemic and solid tumors patients (pts) treated with chemotherapy (CHT) with high mortality rate up to 50-100%. Perforation occurs in 5%-10% of cases. Early diagnosis is crucial to start conservative medical management (CMM), which appears the optimal strategy for most cases.
NEC should be always suspected in Neutropenic pts with abdominal pain, fever and diarrhea.
Ultrasound (US) can be used to evaluate bowel-wall thickening (BWT). The objective of this study is to evaluate prospectively if US can detect early signs of NEC and guide a prompt treatment (CMM or surgical) and thus reduce mortality.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted in Hematology Ward University of Pisa (Italy) to receive chemotherapy who experienced neutropenia related to chemotherapy
排除标准
- •Patients admitted in Hematology Ward University of Pisa (Italy) who did not receive chemotherapy
结局指标
主要结局
to correlate patient's symptoms with outcome
时间窗: from March 2007 to January 2018
Statistical correlation of symptoms with outcome
to verify if bowel wall thickening (BWT) is pathognomonic of neutropenic enterocolitis
时间窗: from March 2007 to January 2018
Comparison of bowel wall thickness in patients with diagnosis of neutropenic enterocolitis and in the control group (NEC negative group)
to verify the hypothesis that US could detect early signs of NEC, guide a prompt treatment eventually reducing mortality
时间窗: from March 2007 to January 2018
Bed side Ultrasound sonography assessment of bowel in neutropenic patients with fever and/or abdominal pain and/or diarrhea
to find which symptom or symptoms have a higher relative risk (RR) for NEC diagnosis
时间窗: from March 2007 to January 2018
Statistical analysis of symptoms in the NEC group at diagnosis
次要结局
未报告次要终点
研究者
Edoardo Benedetti
Medical director
Azienda Ospedaliero, Universitaria Pisana