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

NCT ID: NCT01699516

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intestinal GVHD Neutropenic Enterocolitis

Keywords

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allogeneic transplantation; intestinal graft-vs.-host disease; contrast enhanced ultrasound sonography

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intestinal graft vs host disease

Patients with biopsy-proven intestinal acute GVHD in the setting of an allogenic transplant

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Dr Edoardo Benedetti

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Santa Chiara Hospital University of Pisa

Pisa, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Edoardo Benedetti, MD

Role: CONTACT

Phone: +39050993

Email: [email protected]

Facility Contacts

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Edoardo Benedetti, MD

Role: primary

Other Identifiers

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IRB33982

Identifier Type: -

Identifier Source: org_study_id