Skip to main content
OpenTrials
Completed

NCT Number: NCT02542046

Uniformity of Oral Contrast Material in the Bowel

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Known or Suspected Abdominal Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF

San Francisco, California, 94143-0628, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CT scans in which oral contrast material was given

Exclusion criteria

  • 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

Treatment and study plan

Barium

Drug

Administration of barium oral contrast agent prior to CT scan

Other names: Barium sulfate

Diatrizoate

Drug

Administration of diatrizoate oral contrast agent prior to CT scan

Other names: ionic iodinated contrast agent

Iohexol

Drug

Administration of iohexol oral contrast agent prior to CT scan

Other names: nonionic iodinated contrast agent

Primary outcomes

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

    Time frame: 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.

  2. Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent

    Time frame: 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

Secondary outcomes

  1. Extent of Bowel Opacification of Bowel at CT Imaging

    Time frame: 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.

    The most distal segment of bowel (stomach, jejunum, ileum, and /or colon) that was opacified by contrast material at the time of CT imaging was recorded

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • General Electric

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 4, 2015
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.