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| Name | Class |
|---|---|
| General Electric | INDUSTRY |
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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.
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:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barium | Patients who received barium sulfate oral contrast for abdominopelvic CT |
| |
| diatrizoate | Patients who received diatrizoate oral contrast for abdominopelvic CT |
| |
| iohexol | Patients who received iohexol oral contrast for abdominopelvic CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barium | Drug | Administration of barium oral contrast agent prior to CT scan |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients in our institution who had undergone CT of the Abdomen and Pelvis with administration of positive oral contrast material
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Yeh, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94143-0628 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7719680 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Barium | Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan |
| FG001 | Diatrizoate | Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan |
| FG002 | Iohexol | Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Barium | Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan |
| BG001 | Diatrizoate | Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Barium | Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Yeh | UCaliforniaSF | 4155149318 | ben.yeh@ucsf.edu |
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| ID | Term |
|---|---|
| D001464 | Barium |
| D001466 | Barium Sulfate |
| D003973 | Diatrizoate |
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
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| Diatrizoate | Drug | Administration of diatrizoate oral contrast agent prior to CT scan |
|
|
| Iohexol | Drug | Administration of iohexol oral contrast agent prior to CT scan |
|
|
| BG002 | Iohexol | Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Diatrizoate | Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan |
| OG002 | Iohexol | Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan |
|
|
| 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 | Posted | Count of Participants | Participants | 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 | 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 | Posted | Count of Participants | Participants | 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. |
|
|
|
| 0 |
| 300 |
| 0 |
| 300 |
| 0 |
| 300 |
| EG001 | Diatrizoate | Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan | 0 | 300 | 0 | 300 | 0 | 300 |
| EG002 | Iohexol | Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan | 0 | 300 | 0 | 300 | 0 | 300 |
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| D008670 |
| Metals |
| D017609 | Barium Compounds |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Male |
|
| Severe artifact |
|
| Title | Measurements |
|---|---|
|
| Jejunum |
|
| Ileum |
|
| Colon |
|