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临床试验/NCT02542046
NCT02542046已完成不适用

Uniformity of Oral Contrast Material in the Bowel

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
900
试验地点
1
主要终点
Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging

研究概览

简要总结

Although positive oral contrast agents are used for the majority of abdominopelvic CT scans in the United States, the quality of bowel opacification has not been compared between the three major classes of positive oral contrast material (barium sulfate, ionic iodinated contrast material, and non-ionic iodinate contrast material). This is a retrospective single institution study of clinical records to show whether the uniformity of bowel opacification is different between the three main types of positive CT oral contrast material used in the United States (Barium sulfate, Diatrizoate, and Iohexol). The investigators will retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate, and iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the quality of bowel lumen opacification by the positive oral contrast agents.

详细描述

Although positive oral contrast agents are used for the majority of abdominopelvic CT scans in the United States, the quality of bowel opacification has not been compared between the three major classes of positive oral contrast material (barium sulfate, ionic iodinated contrast material, and non-ionic iodinate contrast material). The investigators will retrospectively identify 250 patients each who received oral barium sulfate, diatrizoate, and iohexol for CT scanning of the abdomen and pelvis (total 750 patients) and assess the quality of bowel lumen opacification by the positive oral contrast agents.

Primary objective:

  • To show the uniformity of bowel opacification is different between the three main types of CT oral contrast material used in the United States (Barium sulfate, Diatrizoate, and Iohexol).

Secondary objectives:

  • To show whether or not one of the oral contrast agents provides more uniform opacification than the others in the proximal or distal bowel
  • To assess the relative opacification of the distal small bowel (ileum) by the three contrast agents.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

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

入选标准

  • CT scans in which oral contrast material was given

排除标准

  • CT scans in which an obvious paucity of oral contrast material is seen,
  • CT scans of patients who had studies within 1 week prior where enteric contrast may have been given, including fluoroscopic, endoscopic, or interventional studies

研究组 & 干预措施

Barium

Patients who received barium sulfate oral contrast for abdominopelvic CT

干预措施: Barium (Drug)

diatrizoate

Patients who received diatrizoate oral contrast for abdominopelvic CT

干预措施: Diatrizoate (Drug)

iohexol

Patients who received iohexol oral contrast for abdominopelvic CT

干预措施: Iohexol (Drug)

结局指标

主要结局

Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging

时间窗: within 1 day from administration of oral contrast. The CT scan generally occurs within 3 hours after oral contrast administration, and the CT scan images will be evaluated for the imaging appearance of oral contrast uniformity for this outcome.

Nonuniform contrast enhancement of the bowel lumen is a potential diagnostic pitfall at CT imaging since non-uniform enhancement may be distracting to the reader and interfere with accurate diagnosis. Conversely, homogeneously enhancing bowel lumen makes it easier to assess the bowel for potential disease. For each patient's CT scan, the bowel that is seen to be visibly opacified by oral contrast at CT imaging will be assessed as a whole as showing the presence or absence of nonuniform contrast enhancement of the lumen.

Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent

时间窗: within 1 day from administration of oral contrast. The CT scan generally occurs within 3 hours after oral contrast administration, and the CT scan images will be evaluated for the imaging appearance of oral contrast uniformity for this outcome.

For the segments of bowel visibly opacified by oral contrast, the severity of CT imaging artifacts caused by the oral contrast agent was recorded on the following 3 point scale: 0 = no artifact; 1 = mild artifact without impairment of anatomic delineation; 2 = severe artifact with impairment of anatomic delineation. Lower scores are preferred

次要结局

  • Extent of Bowel Opacification of Bowel at CT Imaging(within 1 day from administration of oral contrast. The CT scan generally occurs within 3 hours after oral contrast administration, and the CT scan images will be evaluated for imaging appearance of oral contrast seen in bowel for this outcome.)

研究者

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

Benjamin M. Yeh, MD

Professor of Radiology. Principal Investigator

University of California, San Francisco

研究点 (1)

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