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.

Study Overview

• Status: Completed
• Conditions: Known or Suspected Abdominal Disease
• Intervention / Treatment: Drug: Barium; Drug: Diatrizoate; Drug: Iohexol

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 900

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143-0628
      • UCSF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients in our institution who had undergone CT of the Abdomen and Pelvis with administration of positive oral contrast material

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Barium; Patients who received barium sulfate oral contrast for abdominopelvic CT	Drug: Barium; Administration of barium oral contrast agent prior to CT scan; Other Names: Barium sulfate
diatrizoate; Patients who received diatrizoate oral contrast for abdominopelvic CT	Drug: Diatrizoate; Administration of diatrizoate oral contrast agent prior to CT scan; Other Names: ionic iodinated contrast agent
iohexol; Patients who received iohexol oral contrast for abdominopelvic CT	Drug: Iohexol; Administration of iohexol oral contrast agent prior to CT scan; Other Names: nonionic iodinated contrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging	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.	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.
Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of Bowel Opacification of Bowel at CT Imaging	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	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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: General Electric
• Investigators: Principal Investigator: Benjamin Yeh, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Doyle GJ, O'Donnell SC, McDonald JR, Murthy LN, Keir MJ, Wright AR. Evaluation of "Gastromiro" for bowel opacification during computed tomography: comparison with diatrizoate and barium sulphate. Br J Radiol. 1993 Aug;66(788):681-4. doi: 10.1259/0007-1285-66-788-681.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 15-16964

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No