Clinical trial NCT02542046: Uniformity of Oral Contrast Material in the Bowel
Official title: Uniformity of Oral Contrast Material in the Bowel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Known or Suspected Abdominal Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2015-09-04
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging
timeFrame: 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.
measure: Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent
timeFrame: 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 outcomes:
measure: Extent of Bowel Opacification of Bowel at CT Imaging
timeFrame: 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.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Benjamin Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.