Bed-side Ultrasound in Neutropenic Enterocolitis

Neutropenic Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813679
• Other study ID #: NEC_3636
• Status: Completed
• Start date: March 2007
• Est. completion date: January 2018

Study information

• Verified date: March 2021
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1740
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Neutropenic Enterocolitis

Intervention

Diagnostic Test:
• Bed 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

Locations

Country	Name	City	State
Italy	Hematology Unit, Santa Chiara Hospital University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Benedetti E, Baratè C, Bruno B, Bramanti E, Ghia P, Scarfò 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. — View 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. — View 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. — View 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. — View Citation

Benedetti E, Tavarozzi R, Morganti R, Bruno B, Bramanti E, Baratè 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). pii: E2149. doi: 10.3390/jcm9072149. — View 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. Review. — View Citation

Outcome

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