Bed-side Ultrasound in Neutropenic Enterocolitis

NCT04813679 | Completed DMC

• 1 other identifier: NEC_3636
• Study Type: observational
• Target: 1,740
• Locations: 1 country
• Sites: 1

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.

Conditions

Neutropenic Enterocolitis

Keywords

NEC, bed side ultrasound, diagnosis, treatment

Outcome Measures

Primary Outcomes (4)

• 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

• to correlate patient's symptoms with outcome

  Statistical correlation of symptoms with outcome

  from March 2007 to January 2018

• 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

• 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

Study Arms (2)

Neutropenic Enterocolite patients assessed with 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.

Diagnostic Test: Bed side Ultrasound Sonography

Neutropenic Enterocolite negative patients assessed with bed side ultrasound sonography

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

Diagnostic Test: Bed side Ultrasound Sonography

Interventions

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

Also known as: imaging

Neutropenic Enterocolite negative patients assessed with bed side ultrasound sonography; Neutropenic Enterocolite patients assessed with bed side ultrasound sonography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All patients admitted in Hematology Ward University of Pisa (Italy) to receive chemotherapy who experienced neutropenia related to chemotherapy

You may not qualify if:

• Patients admitted in Hematology Ward University of Pisa (Italy) who did not receive chemotherapy

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Hematology Unit, Santa Chiara Hospital University of Pisa

Pisa, 56126, Italy

Location

Related Publications (6)

• 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.

  PMID: 23665821 BACKGROUND

• 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.

  PMID: 32650390 BACKGROUND

• 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.

  PMID: 33316660 BACKGROUND

• 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.

  PMID: 23396497 BACKGROUND

• 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.

  PMID: 23396752 BACKGROUND

• 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.

  PMID: 29357049 BACKGROUND

MeSH Terms

Conditions

Enterocolitis, Neutropenic; Enterocolitis, Necrotizing; Disease

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 24, 2021
• Study Start: March 1, 2007
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)