Clinical trial NCT04813679: Bed-side Ultrasound in Neutropenic Enterocolitis
Official title: Bed-side Ultrasound in the Evaluation of Gastro-intestinal Tract and Neutropenic Enterocolitis (NEC) in Neutropenic Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenic Enterocolitis
Keywords: NEC, bed side ultrasound, diagnosis, treatment
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 1740
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted in Hematology Ward University of Pisa (Italy) from March 2007 to January 2018 to receive chemotherapy who experienced neutropenia related to chemotherapy, were prospectively enrolled

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.


Eligibility criteria: 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

Primary outcomes:
measure: to verify the hypothesis that US could detect early signs of NEC, guide a prompt treatment eventually reducing mortality
timeFrame: from March 2007 to January 2018
measure: to correlate patient's symptoms with outcome
timeFrame: from March 2007 to January 2018
measure: to verify if bowel wall thickening (BWT) is pathognomonic of neutropenic enterocolitis
timeFrame: from March 2007 to January 2018
measure: to find which symptom or symptoms have a higher relative risk (RR) for NEC diagnosis
timeFrame: from March 2007 to January 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Hematology Unit, Santa Chiara Hospital University of Pisa
Study officials:
References:
citation: Benedetti E, Bruno B, McDonald GB, Paolicchi A, Caracciolo F, Papineschi F, Pelosini M, Campani D, Galimberti S, Petrini M. Prospective qualitative and quantitative non-invasive evaluation of intestinal acute GVHD by contrast-enhanced ultrasound sonography. Bone Marrow Transplant. 2013 Nov;48(11):1421-8. doi: 10.1038/bmt.2013.65. Epub 2013 May 13.
citation: Benedetti E, Tavarozzi R, Morganti R, Bruno B, Bramanti E, Barate C, Balducci S, Iovino L, Ricci F, Ricchiuto V, Buda G, Galimberti S. Organ Stiffness in the Work-Up of Myelofibrosis and Philadelphia-Negative Chronic Myeloproliferative Neoplasms. J Clin Med. 2020 Jul 8;9(7):2149. doi: 10.3390/jcm9072149.
citation: Benedetti E, Barate C, Bruno B, Bramanti E, Ghia P, Scarfo L, Morganti R, Ricchiuto V, Galimberti S. Response assessment to venetoclax in relapsed/refractory chronic lymphocytic leukemia by ultrasonography. Leuk Res. 2021 Jan;100:106488. doi: 10.1016/j.leukres.2020.106488. Epub 2020 Nov 30. No abstract available.
citation: Benedetti E, Proietti A, Miccoli P, Basolo F, Ciancia E, Erba PA, Galimberti S, Orsitto E, Petrini M. Contrast-enhanced ultrasonography in nodular splenomegaly associated with type B Niemann-Pick disease: an atypical hemangioma enhancement pattern. J Ultrasound. 2009 Sep;12(3):85-92. doi: 10.1016/j.jus.2009.06.001. Epub 2009 Jul 9.
citation: Benedetti E, Lippolis PV, Caracciolo F, Galimberti S, Papineschi F, Pelosini M, Focosi D, Stella SM, Neri E, Seccia M, Petrini M. Ultrasound findings guided a successful hemicolectomy in a leukemic patient with neutropenic enterocolitis. J Ultrasound. 2008 Sep;11(3):97-101. doi: 10.1016/j.jus.2008.05.001. Epub 2008 Jul 3.
citation: Di Franco G, Tagliaferri E, Pieroni E, Benedetti E, Guadagni S, Palmeri M, Furbetta N, Campani D, Di Candio G, Petrini M, Mosca F, Morelli L. Multiple small bowel perforations due to invasive aspergillosis in a patient with acute myeloid leukemia: case report and a systematic review of the literature. Infection. 2018 Jun;46(3):317-324. doi: 10.1007/s15010-018-1115-7. Epub 2018 Jan 22.