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

NCT03495804 | Unknown

• 1 other identifier: 2018SDU-QILU-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CTE

Keywords

CT enterography; oral contrast agent

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (5)

• Side effects of the two oral contrast agents.

  12 months

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

  12 months

• Dizziness and debilitation of patients.

  12 months

• Temperature of patients.

  12 months

• Blood pressure of patients.

  12 months

Study Arms (2)

mannitol

ACTIVE COMPARATOR

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

polyethylene glycol

EXPERIMENTAL

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

Interventions

polyethylene glycol DRUG

Experimental group was given polyethylene glycol as oral contrast agent.

polyethylene glycol

mannitol DRUG

Active comparator group was given mannitol as oral contrast agent.

mannitol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Polyethylene Glycols; Mannitol

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sugar Alcohols; Carbohydrates

Study Officials

• Yanqing Li, PhD, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, PhD, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomly assigned to group A or B. Participants of group A are given isotonic mannitol as oral contrast agent, while participants of group B are given isotonic polyethylene glycol as oral contrast agent.

Study Record Dates

• First Submitted: January 13, 2018
• First Posted: April 12, 2018
• Study Start: November 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 24, 2018

Record last verified: 2018-08

Locations

CN (1)