Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography

Shandong University

Status: Unknown

Conditions: CTE

Treatments: Drug: mannitol; Drug: polyethylene glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT03495804

2018SDU-QILU-01

Details and patient eligibility

About

CT enterography has become an important tool in the evaluation of small bowel diseases, especially in patients with inflammatory bowel diseases. There are several shortcomings of commonly used isotonic mannitol as an oral contrast agent, such as incident adverse reactions and gases in the gut. However, polyethylene glycol can avoid these drawbacks with a good performance in some pilot experiments.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged from 18 to 75
• patients undergoing CT enterography

Exclusion criteria

• patients with a history of colorectal surgery
• patients with severe colonic stricture or obstructing tumor
• patients with significant gastroparesis or gastric outlet obstruction
• patients with known or suspected bowel obstruction or perforation
• patients with severe chronic renal failure (creatinine clearance<30 ml/min)
• patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
• patients with severe inflammatory bowel disease or megacolon
• patients with documented allergy to intravascular contrast agent
• patients with dehydration
• patients with pregnancy or lactation
• patients hemodynamically unstable
• patients with dysphagia
• patients with severe constipation.
• patients unable to give informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

mannitol

Active Comparator group

Description:

Participants are given a minimum of 1500 mL of a preparation of mannitol as oral contrast agent over an hour prior to the examination.

Treatment:

Drug: mannitol

polyethylene glycol

Experimental group

Description:

Participants are given a minimum of 1500 mL of a preparation of polyethylene glycol as oral contrast agent over an hour prior to the examination.

Treatment:

Drug: polyethylene glycol