Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1740 participants
OBSERVATIONAL
2007-03-31
2018-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
Neutropenic Enterocolite negative patients assessed with bed side ultrasound sonography
NEC negative patients received bed-side ultrasound sonography after three days of neutropenia.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Azienda Ospedaliero, Universitaria Pisana
OTHER
Responsible Party
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Edoardo Benedetti
Medical director
Locations
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Hematology Unit, Santa Chiara Hospital University of Pisa
Pisa, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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NEC_3636
Identifier Type: -
Identifier Source: org_study_id
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