Bed-side Ultrasound in Neutropenic Enterocolitis

Azienda Ospedaliero, Universitaria Pisana

Status: Completed

Conditions: Neutropenic Enterocolitis

Treatments: Diagnostic Test: Bed side Ultrasound Sonography

Study type: Observational

Funder types: Other

Identifiers

NCT04813679

NEC_3636

Details and patient eligibility

About

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.

Enrollment: 1,740 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,740 participants in 2 patient groups

Neutropenic Enterocolite patients assessed with bed side ultrasound sonography

Description:

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.

Treatment:

Diagnostic Test: Bed side Ultrasound Sonography

Neutropenic Enterocolite negative patients assessed with bed side ultrasound sonography

Description:

NEC negative patients received bed-side ultrasound sonography after three days of neutropenia.

Treatment:

Diagnostic Test: Bed side Ultrasound Sonography