Known or Suspected Abdominal Disease
Conditions
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.
Interventions
DRUGBarium
Administration of barium oral contrast agent prior to CT scan
DRUGDiatrizoate
Administration of diatrizoate oral contrast agent prior to CT scan
DRUGIohexol
Administration of iohexol oral contrast agent prior to CT scan
Sponsors
General Electric
University of California, San Francisco
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Non-uniform Bowel Lumen Opacification 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 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Barium Patients who received barium sulfate oral contrast for abdominopelvic CT
Barium: Administration of barium oral contrast agent prior to CT scan | 300 |
| Diatrizoate Patients who received diatrizoate oral contrast for abdominopelvic CT
Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan | 300 |
| Iohexol Patients who received iohexol oral contrast for abdominopelvic CT
Iohexol: Administration of iohexol oral contrast agent prior to CT scan | 300 |
| Total | 900 |
Baseline characteristics
| Characteristic | Barium | Diatrizoate | Iohexol | Total |
|---|---|---|---|---|
| Age, Continuous | 57.8 years | 58.9 years | 58.9 years | 58.5 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 198 Participants | 166 Participants | 186 Participants | 550 Participants |
| Sex: Female, Male Male | 102 Participants | 134 Participants | 114 Participants | 350 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 300 | 0 / 300 | 0 / 300 |
| other Total, other adverse events | 0 / 300 | 0 / 300 | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 | 0 / 300 | 0 / 300 |
Outcome results
Primary
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.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Barium | Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging | 140 Participants |
| Diatrizoate | Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging | 73 Participants |
| Iohexol | Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging | 68 Participants |
Primary
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
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Barium | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | Mild artifact | 4 Participants |
| Barium | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | No artifact | 296 Participants |
| Barium | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | Severe artifact | 0 Participants |
| Diatrizoate | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | Mild artifact | 6 Participants |
| Diatrizoate | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | No artifact | 294 Participants |
| Diatrizoate | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | Severe artifact | 0 Participants |
| Iohexol | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | No artifact | 296 Participants |
| Iohexol | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | Severe artifact | 0 Participants |
| Iohexol | Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent | Mild artifact | 4 Participants |
Secondary
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Barium | Extent of Bowel Opacification of Bowel at CT Imaging | Colon | 105 Participants |
| Barium | Extent of Bowel Opacification of Bowel at CT Imaging | Stomach | 0 Participants |
| Barium | Extent of Bowel Opacification of Bowel at CT Imaging | Jejunum | 24 Participants |
| Barium | Extent of Bowel Opacification of Bowel at CT Imaging | Duodenum | 2 Participants |
| Barium | Extent of Bowel Opacification of Bowel at CT Imaging | Ileum | 169 Participants |
| Diatrizoate | Extent of Bowel Opacification of Bowel at CT Imaging | Duodenum | 0 Participants |
| Diatrizoate | Extent of Bowel Opacification of Bowel at CT Imaging | Colon | 99 Participants |
| Diatrizoate | Extent of Bowel Opacification of Bowel at CT Imaging | Ileum | 174 Participants |
| Diatrizoate | Extent of Bowel Opacification of Bowel at CT Imaging | Stomach | 0 Participants |
| Diatrizoate | Extent of Bowel Opacification of Bowel at CT Imaging | Jejunum | 27 Participants |
| Iohexol | Extent of Bowel Opacification of Bowel at CT Imaging | Colon | 34 Participants |
| Iohexol | Extent of Bowel Opacification of Bowel at CT Imaging | Stomach | 0 Participants |
| Iohexol | Extent of Bowel Opacification of Bowel at CT Imaging | Duodenum | 0 Participants |
| Iohexol | Extent of Bowel Opacification of Bowel at CT Imaging | Ileum | 226 Participants |
| Iohexol | Extent of Bowel Opacification of Bowel at CT Imaging | Jejunum | 40 Participants |