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

Shandong University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

CTE

Interventions

polyethylene glycolDRUG

Experimental group was given polyethylene glycol as oral contrast agent.

mannitolDRUG

Active comparator group was given mannitol as oral contrast agent.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

Performance of two neutral oral contrast agents in CT enterography.

The assessment system includes six parts. 1. Whether the contrast reached the caecum is evaluate and recorded as 'yes' or 'no'. 2. The overall presence of inhomogeneous contrast is evaluated and recorded as 'yes' or 'no'. 3. The maximum dimension of a single loop in each quadrant was recorded. 4. The scale of loops of small bowel distended ≥2 cm are evaluated and recorded as '0-25%', '26-50%', '51-75%' and '76-100%'. 5. The wall visibility and visualization of the small-bowel mucosal are scored on a scale ranging from 1 to 4, in which a higher score represents a better outcome. 6. Overall quality is assessed subjectively by the radiologist and scored on a scale ranging from 1 to 4, in which a higher score represents a better outcome.

Time frame: 12 months

Secondary Outcomes

Side effects of the two oral contrast agents.

The degree of nausea, emesis, diarrhea, abdominal distension and cramp following ingestion are scored on a scale ranging from 0 to 10, in which a higher score represents a higher level of these targets.

Time frame: 12 months

The flavor, volume and participants' willing for the second use of the two oral contrast agents in CT enterography.

The flavor, volume and participants' willing for the second use are scored on a scale ranging from 0 to 10, in which a higher score represents a better outcome.

Time frame: 12 months

Dizziness and debilitation of patients.

The presence of dizziness and debilitation are recorded as 'yes' or 'no'.

Time frame: 12 months

Temperature of patients.

The temperature of patients are recorded in degree centigrade.

Time frame: 12 months

Central Contacts

Yanqing Li, PhD, MD

CONTACT

86-531-82169236 liyanqing@sdu.edu.cn

Data from ClinicalTrials.gov

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