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

CTE Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03495804
• Other study ID #: 2018SDU-QILU-01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: October 2018

Study information

• Verified date: August 2018
• Source: Shandong University
• Contact: Yanqing Li, PhD, MD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. However, polyethylene glycol can avoid these drawbacks with a good performance in some pilot experiments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• CTE

Intervention

Drug:
• polyethylene glycol
Experimental group was given polyethylene glycol as oral contrast agent.
• mannitol
Active comparator group was given mannitol as oral contrast agent.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Dizziness and debilitation of patients.	The presence of dizziness and debilitation are recorded as 'yes' or 'no'.	12 months
Secondary	Temperature of patients.	The temperature of patients are recorded in degree centigrade.	12 months
Secondary	Blood pressure of patients.	The blood pressure of patients are recorded in millimeter of mercury.	12 months