Uniformity of Oral Contrast Material in the Bowel

NCT ID: NCT02542046

Last Updated: 2019-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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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). 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.

Conditions

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Known or Suspected Abdominal Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Barium

Patients who received barium sulfate oral contrast for abdominopelvic CT

Barium

Intervention Type DRUG

Administration of barium oral contrast agent prior to CT scan

diatrizoate

Patients who received diatrizoate oral contrast for abdominopelvic CT

Diatrizoate

Intervention Type DRUG

Administration of diatrizoate oral contrast agent prior to CT scan

iohexol

Patients who received iohexol oral contrast for abdominopelvic CT

Iohexol

Intervention Type DRUG

Administration of iohexol oral contrast agent prior to CT scan

Interventions

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Barium

Administration of barium oral contrast agent prior to CT scan

Intervention Type DRUG

Diatrizoate

Administration of diatrizoate oral contrast agent prior to CT scan

Intervention Type DRUG

Iohexol

Administration of iohexol oral contrast agent prior to CT scan

Intervention Type DRUG

Other Intervention Names

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Barium sulfate ionic iodinated contrast agent nonionic iodinated contrast agent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Electric

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Benjamin M. Yeh, MD

Professor of Radiology. Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7719680 (View on PubMed)

Other Identifiers

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15-16964

Identifier Type: -

Identifier Source: org_study_id

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