Skip to main content
OpenTrials
Completed

NCT Number: NCT04813679

Bed-side Ultrasound in Neutropenic Enterocolitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neutropenic Enterocolitis Digestive System Diseases Disease Enterocolitis Enterocolitis, Necrotizing Enterocolitis, Neutropenic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hematology Unit, Santa Chiara Hospital University of Pisa

Pisa, 56126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bed side Ultrasound Sonography

Diagnostic Test

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

Other names: imaging

Primary outcomes

  1. to verify the hypothesis that US could detect early signs of NEC, guide a prompt treatment eventually reducing mortality

    Time frame: 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

  2. to correlate patient's symptoms with outcome

    Time frame: from March 2007 to January 2018

    Statistical correlation of symptoms with outcome

  3. to verify if bowel wall thickening (BWT) is pathognomonic of neutropenic enterocolitis

    Time frame: 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)

  4. to find which symptom or symptoms have a higher relative risk (RR) for NEC diagnosis

    Time frame: from March 2007 to January 2018

    Statistical analysis of symptoms in the NEC group at diagnosis

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2021
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.