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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495804
Recruitment Status : Unknown
Verified August 2018 by Yanqing Li, Shandong University.
Recruitment status was:  Recruiting
First Posted : April 12, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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.

Condition or disease Intervention/treatment Phase
CTE Drug: polyethylene glycol Drug: mannitol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography (CTE)
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Performance of two neutral oral contrast agents in CT enterography. [ Time Frame: 12 months ]

    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.


Secondary Outcome Measures :
  1. Side effects of the two oral contrast agents. [ Time Frame: 12 months ]
    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.

  2. The flavor, volume and participants' willing for the second use of the two oral contrast agents in CT enterography. [ Time Frame: 12 months ]
    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.

  3. Dizziness and debilitation of patients. [ Time Frame: 12 months ]
    The presence of dizziness and debilitation are recorded as 'yes' or 'no'.

  4. Temperature of patients. [ Time Frame: 12 months ]
    The temperature of patients are recorded in degree centigrade.

  5. Blood pressure of patients. [ Time Frame: 12 months ]
    The blood pressure of patients are recorded in millimeter of mercury.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495804


Contacts
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Contact: Yanqing Li, PhD, MD 86-531-82169236 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD, PhD    86-531-82169236    liyanqing@sdu.edu.cn   
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Yanqing Li, PhD, MD Qilu Hospital, Shandong University
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Responsible Party: Yanqing Li, Professor, Shandong University
ClinicalTrials.gov Identifier: NCT03495804    
Other Study ID Numbers: 2018SDU-QILU-01
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanqing Li, Shandong University:
CT enterography
oral contrast agent
Additional relevant MeSH terms:
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Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs