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

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

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 Overview

• Status: Unknown
• Conditions: CTE
• Intervention / Treatment: Drug: mannitol; Drug: polyethylene glycol

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: mannitol; Participants are given a minimum of 1500 mL of a preparation of mannitol as oral contrast agent over an hour prior to the examination.	Drug: mannitol; Active comparator group was given mannitol as oral contrast agent.
Experimental: polyethylene glycol; 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.	Drug: polyethylene glycol; Experimental group was given polyethylene glycol as oral contrast agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of two neutral oral contrast agents in CT enterography.	The assessment system includes six parts.; Whether the contrast reached the caecum is evaluate and recorded as 'yes' or 'no'.; The overall presence of inhomogeneous contrast is evaluated and recorded as 'yes' or 'no'.; The maximum dimension of a single loop in each quadrant was recorded.; The scale of loops of small bowel distended ≥2 cm are evaluated and recorded as '0-25%', '26-50%', '51-75%' and '76-100%'.; 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.; 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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 months
Dizziness and debilitation of patients.	The presence of dizziness and debilitation are recorded as 'yes' or 'no'.	12 months
Temperature of patients.	The temperature of patients are recorded in degree centigrade.	12 months
Blood pressure of patients.	The blood pressure of patients are recorded in millimeter of mercury.	12 months

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Yanqing Li, PhD, MD, Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: January 13, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: CT enterography; oral contrast agent
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: 2018SDU-QILU-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No