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Non-invasive Contrast Enhanced Ultrasound Sonography in Intestinal Acute Graft-vs-Host Disease

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ClinicalTrials.gov Identifier: NCT01699516
Recruitment Status : Unknown
Verified October 2012 by Dr Edoardo Benedetti, University of Pisa.
Recruitment status was:  Recruiting
First Posted : October 3, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
Dr Edoardo Benedetti, University of Pisa

Brief Summary:
Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011. Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group. Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control group. All patients were evaluated with both standard transabdominal ultrasonography (US) and CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms. Standard US revealed non-specific bowel wall thickening, and simultaneous involvement of multiple intestinal segments in 9/14 patients. CEUS showed three distinct patterns of microcirculation changes that correlated with GVHD activity. These findings were not observed in the control group. Moreover, CEUS findings correlated with treatment response and predicted flare of intestinal symptoms. CEUS is a non-invasive, easily reproducible bed-side tool to detect and monitor intestinal GVHD.

Condition or disease
Intestinal GVHD Neutropenic Enterocolitis

Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Study on Qualitative and Quantitative Non-invasive Evaluation of Intestinal Acute Graft-vs-host Disease by Contrast Enhanced Ultrasound Sonography
Study Start Date : January 2008
Actual Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Group/Cohort
Intestinal graft vs host disease
Patients with biopsy-proven intestinal acute GVHD in the setting of an allogenic transplant
Control group
In the setting of an allogenic bone marrow transplant: patients with biopsy-proven stomach GVHD without intestinal symptoms and patients with neutropenic enterocolitis. Normal volunteers.




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Ages Eligible for Study:   22 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
In the setting of allogenic transplant: intestinal acute graft vs host disease (GVHD), stomach GVHD, neutropenic enterocolitis.
Criteria

Inclusion Criteria:

  • Bone Marrow Transplant
  • intestinal acute graft versus host disease
  • stomach GVHD
  • neutropenic enterocolitis

Exclusion Criteria:

no biopsy proven intestinal or stomach GVHD no neutropenic enterocolitis


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699516


Contacts
Contact: Edoardo Benedetti, MD +39050993 ext 085 edobenedetti@gmail.com

Locations
Italy
Santa Chiara Hospital University of Pisa Recruiting
Pisa, Italy, 56127
Contact: Edoardo Benedetti, MD    +39050993 ext 085    edobenedetti@gmail.com   
Principal Investigator: Edoardo Benedetti, MD         
Sponsors and Collaborators
University of Pisa

Responsible Party: Dr Edoardo Benedetti, MD, University of Pisa
ClinicalTrials.gov Identifier: NCT01699516     History of Changes
Other Study ID Numbers: IRB33982
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012

Keywords provided by Dr Edoardo Benedetti, University of Pisa:
allogeneic transplantation; intestinal graft-vs.-host disease; contrast enhanced ultrasound sonography

Additional relevant MeSH terms:
Enterocolitis
Graft vs Host Disease
Enterocolitis, Neutropenic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immune System Diseases