Non-invasive Contrast Enhanced Ultrasound Sonography in Intestinal Acute Graft-vs-Host Disease
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.
|Study Design:||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|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Intestinal graft vs host disease
Patients with biopsy-proven intestinal acute GVHD in the setting of an allogenic transplant
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699516
|Contact: Edoardo Benedetti, MD||+39050993 ext email@example.com|
|Santa Chiara Hospital University of Pisa||Recruiting|
|Pisa, Italy, 56127|
|Contact: Edoardo Benedetti, MD +39050993 ext 085 firstname.lastname@example.org|
|Principal Investigator: Edoardo Benedetti, MD|