跳至主要内容
临床试验/NCT01699516
NCT01699516Unknown不适用

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

University of Pisa1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
22 Years 至 66 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • no biopsy proven intestinal or stomach GVHD no neutropenic enterocolitis

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Edoardo Benedetti

MD

University of Pisa

研究点 (1)

Loading locations...

相似试验