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

NCT01699516 | Unknown

• 1 other identifier: IRB33982
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal GVHD; Neutropenic Enterocolitis

Keywords

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

Study Arms (2)

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 Criteria

• Age: 22 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• no biopsy proven intestinal or stomach GVHD no neutropenic enterocolitis

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

Santa Chiara Hospital University of Pisa

Pisa, 56127, Italy

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Neutropenic

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Edoardo Benedetti, MD

CONTACT

+39050993; edobenedetti@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: January 1, 2008
• Primary Completion: May 1, 2012
• Last Updated: October 3, 2012

Record last verified: 2012-10

Locations

IT (1)