Uniformity of Oral Contrast Material in the Bowel

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT02542046
• Collaborator: General Electric (Industry)
• Enrollment: 900
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 32.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Known or Suspected Abdominal Disease	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 Design

• Study Type: Observational
• Actual Enrollment: 900 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Uniformity of Oral Contrast Material in the Bowel
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF	San Francisco	California	United States	94143-0628

Sponsors and Collaborators

• University of California, San Francisco
• General Electric

Investigators

• Principal Investigator: Benjamin Yeh, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Benjamin M. Yeh, MD, Professor of Radiology. Principal Investigator, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02542046
• Other Study ID Numbers: 15-16964
• First Posted: Sep 4, 2015
• Last Update Posted: Dec 11, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Barium	Diatrizoate	Iohexol
Arm/Group Description	Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
Period Title: Overall Study
STARTED	300	300	300
COMPLETED	300	300	300
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Barium	Diatrizoate	Iohexol	Total
Arm/Group Description	Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan	Total of all reporting groups
Overall Participants	300	300	300	900
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	57.8	58.9	58.9	58.5
Sex: Female, Male (Count of Participants)
Female	198 66%	166 55.3%	186 62%	550 61.1%
Male	102 34%	134 44.7%	114 38%	350 38.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Barium	Diatrizoate	Iohexol
Arm/Group Description	Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
Measure Participants	300	300	300
Count of Participants [Participants]	140 46.7%	73 24.3%	68 22.7%

2. Primary Outcome

Title	Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Barium	Diatrizoate	Iohexol
Arm/Group Description	Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
Measure Participants	300	300	300
No artifact	296 98.7%	294 98%	296 98.7%
Mild artifact	4 1.3%	6 2%	4 1.3%
Severe artifact	0 0%	0 0%	0 0%

3. Secondary Outcome

Title	Extent of Bowel Opacification of Bowel at CT Imaging
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Barium	Diatrizoate	Iohexol
Arm/Group Description	Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
Measure Participants	300	300	300
Stomach	0 0%	0 0%	0 0%
Duodenum	2 0.7%	0 0%	0 0%
Jejunum	24 8%	27 9%	40 13.3%
Ileum	169 56.3%	174 58%	226 75.3%
Colon	105 35%	99 33%	34 11.3%

Adverse Events

Arm/Group Title	Barium		Diatrizoate		Iohexol
Arm/Group Description	Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan		Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan		Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
All Cause Mortality
	Barium		Diatrizoate		Iohexol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/300 (0%)		0/300 (0%)		0/300 (0%)
Serious Adverse Events
	Barium		Diatrizoate		Iohexol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/300 (0%)		0/300 (0%)		0/300 (0%)
Other (Not Including Serious) Adverse Events
	Barium		Diatrizoate		Iohexol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/300 (0%)		0/300 (0%)		0/300 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.