Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles

Colorectal Neoplasms Clinical Trial

Official title:

Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790139
• Other study ID #: 2012-0584
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: March 24, 2014
• Start date: February 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

Description:

CT colonography (CTC) is a recently developed radiological examination to find colorectal neoplasia. Fecal/fluid tagging using oral administration of contrast is an essential procedure for CTC. Iohexol, which has recently started being used as an agent for fecal/fluid tagging, has great advantages as it has much more tolerable taste and much lower rates of adverse effects such as clamping or diarrhea compared with traditionally used Gastrografin/Gastroview. However, iohexol is frequently associated with an occurrence of a lot of bubbles in the colon, which makes CTC interpretation more time-consuming and laborious.

Past experience in colonoscopy field suggests that simethicone, a safety-proven highly inexpensive over-the-counter medicine, might resolve this issue. Given the fact that patient convenience is an important factor for a successful CTC and the fact that time-intensive nature of CTC interpretation is one of the major deterrents to wide spread adoption of CTC while CTC also needs to be as time efficient as possible in order to effectively serve the role of population screening for colorectal cancer, investigating the effect of simethicone to prevent the colonic bubbles on the time efficiency of CTC interpretation would be important. If simethicone can resolve the colonic bubble problem, CTC can be performed more conveniently for the patients as well as for the interpreting radiologists.

This study is to determine whether colonic bubbles associated with CT colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who are schedule to undergo colonoscopy for a suspicion of colonic neoplasia at the investigators' institution

• Those who agree to participate in the study

Exclusion Criteria:

• Colonoscopy for reasons other than detecting colonic neoplasia, e.g. evaluation of inflammatory bowel disease

• Contraindications to iodinated contrast including renal insufficiency, hypersensitivity, and hyperthyroidism

• Acute severe colonic obstruction which is likely preclude safe and successful performance of CTC

• Patient who is suspicious for colonic perforation

• Pregnancy

• Phenylketonuria (contraindication to simethicone)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Oral simethicone
10 mL of simethicone is administered as an agent to prevent colonic bubbles

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	GE Healthcare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic bubble-related image quality	Colonic bubble-specific image quality is evaluated semi-quantitatively in terms of colonic mucosal surface obscured/covered by colonic bubbles.	within 1 month after assessment of the other primary endpoint	No
Secondary	Overall image quality	Overall image quality according to the CT Colonography Reporting and Data System. Rate of C0, i.e. polyps 1 cm or larger cannot be excluded due to insufficient technical quality, is assessed.	within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients	No
Secondary	diagnostic performance	diagnostic performance of CT colonography for detecting colonic adenoma or carcinoma 6 mm or greater in diameter	within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients	No