CTENCT03495804
Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography
A study testing polyethylene glycol and mannitol in people with CTE, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CTE
- What is being tested?
- polyethylene glycol and mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged from 18 to 75
- patients undergoing CT enterography
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD, PhD, 86-531-82169236, liyanqing@sdu.edu.cn
About this study
Official title: 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.
- Conditions
- CTE
- Being tested
- polyethylene glycol, mannitol
- Keywords
- CT enterography, oral contrast agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycolDrug
Experimental group was given polyethylene glycol as oral contrast agent.
mannitolDrug
Active comparator group was given mannitol as oral contrast agent.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 12 months
Dizziness and debilitation of patients.
The presence of dizziness and debilitation are recorded as 'yes' or 'no'.
Measured: 12 months
Temperature of patients.
The temperature of patients are recorded in degree centigrade.
Measured: 12 months
Blood pressure of patients.
The blood pressure of patients are recorded in millimeter of mercury.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Nov 2017
- Primary completionSep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495804
- Sponsor's protocol ID
- 2018SDU-QILU-01
- Status last verified
- Aug 2018
- First submitted
- 13 Jan 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of Two Neutral Oral Contrast Agents in CT Enterography (CTE)
- ClinicalTrials.gov ID
- NCT03495804
- Acronym / sponsor ID
- 2018SDU-QILU-01
- Conditions
- CTE
- Keywords
- CT enterography, oral contrast agent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| mannitol | Active comparator | Drug: mannitolParticipants are given a minimum of 1500 mL of a preparation of mannitol as oral contrast agent over an hour prior to the examination. |
| polyethylene glycol | Experimental | Drug: polyethylene glycolParticipants are given a minimum of 1500 mL of a preparation of polyethylene glycol as oral contrast agent over an hour prior to the examination. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged from 18 to 75
- patients undergoing CT enterography
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethylene glycolExperimental group was given polyethylene glycol as oral contrast agent. | Drug | polyethylene glycol |
| mannitolActive comparator group was given mannitol as oral contrast agent. | Drug | mannitol |
Primary outcome
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.
5 secondary outcomes
Side effects of the two oral contrast agents.
Time frame: 12 months
The flavor, volume and participants' willing for the second use of the two oral contrast agents in CT enterography.
Time frame: 12 months
Dizziness and debilitation of patients.
Time frame: 12 months
Temperature of patients.
Time frame: 12 months
Blood pressure of patients.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li, PhD, MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyethylene glycol and mannitol in people with CTE, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, PhD, MD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of two neutral oral contrast agents in CT enterography. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.