Bed-side Ultrasound in Neutropenic Enterocolitis

Completed

• Conditions: Neutropenic Enterocolitis

• Registration Number: NCT04813679
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2021-03
• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-21
• Last Update Submitted: 2021-03-21
• Study First Posted: 2021-03-24
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1740

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to correlate patient's symptoms with outcome	from March 2007 to January 2018	Statistical correlation of symptoms with outcome
to verify if bowel wall thickening (BWT) is pathognomonic of neutropenic enterocolitis	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	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	from March 2007 to January 2018	Statistical analysis of symptoms in the NEC group at diagnosis

Trial Locations

Locations (1)

Hematology Unit, Santa Chiara Hospital University of Pisa; 🇮🇹 Pisa, Italy