Bed-side Ultrasound in Neutropenic Enterocolitis

Completed

• Conditions: Neutropenic Enterocolitis
• Interventions: Diagnostic Test: Bed side Ultrasound Sonography

• 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

Arm && Interventions

Group	Intervention	Description
Neutropenic Enterocolite negative patients assessed with bed side ultrasound sonography	Bed side Ultrasound Sonography	NEC negative patients received bed-side ultrasound sonography after three days of neutropenia.
Neutropenic Enterocolite patients assessed with bed side ultrasound sonography	Bed side Ultrasound Sonography	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.

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