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

October 1, 2012 updated by: Dr Edoardo Benedetti, University of Pisa

A Prospective Study on Qualitative and Quantitative Non-invasive Evaluation of Intestinal Acute Graft-vs-host Disease by Contrast Enhanced Ultrasound Sonography

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pisa, Italy, 56127
        • Recruiting
        • Santa Chiara Hospital University of Pisa
        • Contact:
        • Principal Investigator:
          • Edoardo Benedetti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 66 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In the setting of allogenic transplant: intestinal acute graft vs host disease (GVHD), stomach GVHD, neutropenic enterocolitis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

October 1, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (ESTIMATE)

October 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB33982

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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