Trial Outcomes & Findings for Uniformity of Oral Contrast Material in the Bowel (NCT NCT02542046)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

900 participants

Primary outcome 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.

Results posted on

2019-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	Barium Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Diatrizoate Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Iohexol Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
Overall Study STARTED	300	300	300
Overall Study COMPLETED	300	300	300
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Barium n=300 Participants Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Diatrizoate n=300 Participants Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Iohexol n=300 Participants Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan	Total n=900 Participants Total of all reporting groups
Age, Continuous	57.8 years n=300 Participants	58.9 years n=300 Participants	58.9 years n=300 Participants	58.5 years n=900 Participants
Sex: Female, Male Female	198 Participants n=300 Participants	166 Participants n=300 Participants	186 Participants n=300 Participants	550 Participants n=900 Participants
Sex: Female, Male Male	102 Participants n=300 Participants	134 Participants n=300 Participants	114 Participants n=300 Participants	350 Participants n=900 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

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.

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.

Outcome measures

Outcome measures
Measure	Barium n=300 Participants Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Diatrizoate n=300 Participants Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Iohexol n=300 Participants Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging	140 Participants	73 Participants	68 Participants

PRIMARY outcome

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.

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

Outcome measures

Outcome measures
Measure	Barium n=300 Participants Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Diatrizoate n=300 Participants Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Iohexol n=300 Participants Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent No artifact	296 Participants	294 Participants	296 Participants
Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent Mild artifact	4 Participants	6 Participants	4 Participants
Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent Severe artifact	0 Participants	0 Participants	0 Participants

SECONDARY outcome

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.

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

Outcome measures

Outcome measures
Measure	Barium n=300 Participants Patients who received barium sulfate oral contrast for abdominopelvic CT Barium: Administration of barium oral contrast agent prior to CT scan	Diatrizoate n=300 Participants Patients who received diatrizoate oral contrast for abdominopelvic CT Diatrizoate: Administration of diatrizoate oral contrast agent prior to CT scan	Iohexol n=300 Participants Patients who received iohexol oral contrast for abdominopelvic CT Iohexol: Administration of iohexol oral contrast agent prior to CT scan
Extent of Bowel Opacification of Bowel at CT Imaging Stomach	0 Participants	0 Participants	0 Participants
Extent of Bowel Opacification of Bowel at CT Imaging Duodenum	2 Participants	0 Participants	0 Participants
Extent of Bowel Opacification of Bowel at CT Imaging Jejunum	24 Participants	27 Participants	40 Participants
Extent of Bowel Opacification of Bowel at CT Imaging Ileum	169 Participants	174 Participants	226 Participants
Extent of Bowel Opacification of Bowel at CT Imaging Colon	105 Participants	99 Participants	34 Participants

Adverse Events

Barium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diatrizoate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Iohexol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benjamin Yeh

UCaliforniaSF

Phone: 4155149318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place