Neutropenic EnterocolitisNCT04813679
Bed-side Ultrasound in Neutropenic Enterocolitis
An observational study of Neutropenic Enterocolitis, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenic Enterocolitis
- What is being tested?
- Bed side Ultrasound Sonography
- How many people
- 1,740 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All patients admitted in Hematology Ward University of Pisa (Italy) to receive chemotherapy who experienced neutropenia related to chemotherapy
Who cannot join
- Patients admitted in Hematology Ward University of Pisa (Italy) who did not receive chemotherapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Hematology Unit, Santa Chiara Hospital University of Pisa
Pisa, 56126
About this study
Official title: Bed-side Ultrasound in the Evaluation of Gastro-intestinal Tract and Neutropenic Enterocolitis (NEC) in Neutropenic Patients.
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
- Being tested
- Bed side Ultrasound Sonography
- Keywords
- NEC, bed side ultrasound, diagnosis, treatment
- Medical subject headings
- Enterocolitis, Neutropenic, Enterocolitis, Necrotizing, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed side Ultrasound SonographyDiagnostic test
Also called imaging
Bed side Ultrasound in Neutropenic patients within 12 h from onset of any symptom such as fever and/or abdominal pain and/or diarreha
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Bed side Ultrasound Sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from March 2007 to January 2018
to correlate patient's symptoms with outcome
Statistical correlation of symptoms with outcome
Measured: 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)
Measured: 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
Measured: from March 2007 to January 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study startMar 2007
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neutropenic EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edoardo Benedetti, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813679
- Sponsor's protocol ID
- NEC_3636
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23665821Benedetti 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.
PubMed 32650390Benedetti 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.
PubMed 33316660Benedetti 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.
PubMed 23396497Benedetti 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.
PubMed 23396752Di 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.
PubMed 29357049
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bed-side Ultrasound in the Evaluation of Gastro-intestinal Tract and Neutropenic Enterocolitis (NEC) in Neutropenic Patients.
- ClinicalTrials.gov ID
- NCT04813679
- Acronym / sponsor ID
- NEC_3636
- Conditions
- Neutropenic Enterocolitis
- Keywords
- NEC, bed side ultrasound, diagnosis, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,740 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- Mar 2007 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutropenic Enterocolite patients assessed with bed side ultrasound sonography | – | Diagnostic Test: Bed side Ultrasound SonographyFrom 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. |
| Neutropenic Enterocolite negative patients assessed with bed side ultrasound sonography | – | Diagnostic Test: Bed side Ultrasound SonographyNEC negative patients received bed-side ultrasound sonography after three days of neutropenia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients admitted in Hematology Ward University of Pisa (Italy) to receive chemotherapy who experienced neutropenia related to chemotherapy
Key exclusion criteria (1 listed)
- Patients admitted in Hematology Ward University of Pisa (Italy) who did not receive chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed side Ultrasound SonographyAlso: imagingBed side Ultrasound in Neutropenic patients within 12 h from onset of any symptom such as fever and/or abdominal pain and/or diarreha | Diagnostic test | Neutropenic Enterocolite negative patients assessed with bed side ultrasound sonography, Neutropenic Enterocolite patients assessed with bed side ultrasound sonography |
Primary outcome
to verify the hypothesis that US could detect early signs of NEC, guide a prompt treatment eventually reducing mortality
Time frame: from March 2007 to January 2018
Bed side Ultrasound sonography assessment of bowel in neutropenic patients with fever and/or abdominal pain and/or diarrhea
to correlate patient's symptoms with outcome
Time frame: from March 2007 to January 2018
Statistical correlation of symptoms with outcome
to verify if bowel wall thickening (BWT) is pathognomonic of neutropenic enterocolitis
Time frame: from March 2007 to January 2018
Comparison of bowel wall thickness in patients with diagnosis of neutropenic enterocolitis and in the control group (NEC negative group)
to find which symptom or symptoms have a higher relative risk (RR) for NEC diagnosis
Time frame: from March 2007 to January 2018
Statistical analysis of symptoms in the NEC group at diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 23665821Benedetti 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.
- Background: PubMed 32650390Benedetti 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.
- Background: PubMed 33316660Benedetti 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.
- Background: PubMed 23396497Benedetti 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.
- Background: PubMed 23396752Benedetti 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.
- Background: PubMed 29357049Di 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenic Enterocolitis, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to verify the hypothesis that US could detect early signs of NEC, guide a prompt treatment eventually reducing mortality (time frame: from March 2007 to January 2018). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813679, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.