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

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Oral simethicone

• Registration Number: NCT01790139
• Lead Sponsor: Asan Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention-Oral Simethicone	Oral simethicone	Intervention group undergoes CT colonography after usual cathartic bowel cleansing using Colonlyte, fecal/fluid tagging, and oral administration of simethicone. The tagging is done by administering orally 50 mL of iohexol (Omnipaque 350, GE Healthcare) 10 minutes after the completion of Colonlyte. As the interventional procedure in this intervention group, 10 mL of simethicone is administered orally immediately following the administration of iohexol.

Primary Outcome Measures

Name	Time	Method
Colonic bubble-related image quality	within 1 month after assessment of the other primary endpoint	Colonic bubble-specific image quality is evaluated semi-quantitatively in terms of colonic mucosal surface obscured/covered by colonic bubbles.

Secondary Outcome Measures

Name	Time	Method
Overall image quality	within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients	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.
diagnostic performance	within 3 months after enrollment of all the patients and acquisition of CT colonography in all enrolled patients	diagnostic performance of CT colonography for detecting colonic adenoma or carcinoma 6 mm or greater in diameter

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of