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Bed-side Ultrasound in Neutropenic Enterocolitis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04813679
Enrollment
1740
Registered
2021-03-24
Start date
2007-03-31
Completion date
2018-01-31
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenic Enterocolitis

Keywords

NEC, bed side ultrasound, diagnosis, treatment

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.

Interventions

DIAGNOSTIC_TESTBed side Ultrasound Sonography

Bed side Ultrasound in Neutropenic patients within 12 h from onset of any symptom such as fever and/or abdominal pain and/or diarreha

Sponsors

Azienda Ospedaliero, Universitaria Pisana
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026