Bed-side Ultrasound in Neutropenic Enterocolitis

Study Overview
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Brief Summary
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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.

Official Title
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Bed-side Ultrasound in the Evaluation of Gastro-intestinal Tract and Neutropenic Enterocolitis (NEC) in Neutropenic Patients.

Conditions
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Neutropenic Enterocolitis

Intervention / Treatment
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* Diagnostic Test: Bed side Ultrasound Sonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted in Hematology Ward University of Pisa (Italy) to receive chemotherapy who experienced neutropenia related to chemotherapy Exclusion Criteria: Patients admitted in Hematology Ward University of Pisa (Italy) who did not receive chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neutropenic Enterocolite patients assessed with bed side ultrasound sonography<br>From March 2007 through the entire study period all patients admitted eighter in our chemotherapy-ward or BMT-ward to receive intensive chemotherapy (chemo) for any hematological malignancies, or chemotherapy (CHT) for both auto transplant (ASTC) and allogeneic transplant (AlloTx), were prospectively enrolled in the study. When the patient received more than one chemo cycle, each ward access was considered a new observational period. Patients who received CHT and experienced CHT-induced neutropenia (CHTNP) were enrolled in the study. We defined one observational period each admission on the ward to receive CHT, in which CHT and length of stay could vary from the previous admission. One observational period ended with the discharge of the pts form the ward. If a pts experienced a new chemo related NECe during another admission, it was considered as e new NECe. | Diagnostic Test: Bed side Ultrasound Sonography<br>* Bed side Ultrasound in Neutropenic patients within 12 h from onset of any symptom such as fever and/or abdominal pain and/or diarreha<br>* Other names: imaging;|
| Neutropenic Enterocolite negative patients assessed with bed side ultrasound sonography<br>NEC negative patients received bed-side ultrasound sonography after three days of neutropenia. | Diagnostic Test: Bed side Ultrasound Sonography<br>* Bed side Ultrasound in Neutropenic patients within 12 h from onset of any symptom such as fever and/or abdominal pain and/or diarreha<br>* Other names: imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to verify the hypothesis that US could detect early signs of NEC, guide a prompt treatment eventually reducing mortality | Bed side Ultrasound sonography assessment of bowel in neutropenic patients with fever and/or abdominal pain and/or diarrhea | from March 2007 to January 2018 | 
| to correlate patient's symptoms with outcome | Statistical correlation of symptoms with outcome | from March 2007 to January 2018 | 
| to verify if bowel wall thickening (BWT) is pathognomonic of neutropenic enterocolitis | Comparison of bowel wall thickness in patients with diagnosis of neutropenic enterocolitis and in the control group (NEC negative group) | from March 2007 to January 2018 | 
| to find which symptom or symptoms have a higher relative risk (RR) for NEC diagnosis | Statistical analysis of symptoms in the NEC group at diagnosis | from March 2007 to January 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NEC, bed side ultrasound, diagnosis, treatment