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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University of Pisa.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr Edoardo Benedetti, University of Pisa
ClinicalTrials.gov Identifier:
NCT01699516
First received: October 1, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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
Intestinal GVHD
Neutropenic Enterocolitis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Pisa:

Estimated Enrollment: 32
Study Start Date: January 2008
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   22 Years to 66 Years
Genders Eligible for Study:   Both
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr Edoardo Benedetti, MD, University of Pisa
ClinicalTrials.gov Identifier: NCT01699516     History of Changes
Other Study ID Numbers: IRB33982
Study First Received: October 1, 2012
Last Updated: October 1, 2012
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 21, 2014