Clinical Trials Logo

Clinical Trial Summary

This study first is designed to see what dose of indigo carmine ingested orally mixed with the standard colonoscopy prep is needed to provide adequate staining of the right colon. It then will use this adequate staining concentration of Indigo Carmine to study whether this dye will increase the detection of polyps during colonoscopy.


Clinical Trial Description

Colon cancer occurs in 5% of the US population. Currently colon cancer screening is recommended at the age of 50 years old for all patients who are at average risk. Colonoscopy is considered the gold standard test for colon cancer screening. This is partly because colonoscopy not only can detect polyps which are cancer precursors but also can remove them, and thereby detecting cancer and its precursors and preventing cancer. Unfortunately recent data suggest that colonoscopy can miss a significant percentage of polyps, especially on the right side of the colon. It is thought that one of the major reasons for missing polyps in the right side of the colon is the fact that they are flat or sessile serrated adenoma, both of which are more difficult than protruding polyps to identify with ordinary colon preparation and colonoscopes. Chromoendoscopy is the application of dye during colonoscopy to enhance detection of polyps. It has been shown that it improves the detection of polyps and thus has the potential of improving the performance of colonoscopy and increasing the detection of these difficult to detect polyps. It is however cumbersome and time consuming, which has discouraged its use. Indigo carmine, one commonly used dye, is actually FDA approved as a food colorant and can be consumed orally. It is minimally absorbed. In addition it is used intravenously for diagnosis of injuries of the urinary system because it is very rapidly excreted by the kidneys. The investigators believe that taking it orally will be well tolerated, and that any of the dye that is absorbed will be rapidly excreted by the kidneys and thus quickly eliminated without any side effects. Effective staining of the colon with indigo carmine and increased detection of polyps could change the current standard of care for screening for colon cancer. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01901510
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 1
Start date May 2013
Completion date July 2014

See also
  Status Clinical Trial Phase
Completed NCT05615857 - Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary N/A
Not yet recruiting NCT02865382 - Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy N/A
Completed NCT02529007 - Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Completed NCT01712048 - Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps N/A
Terminated NCT01297712 - Endoscopic Assessment of Polyp Histology N/A
Active, not recruiting NCT01368289 - Australian Multicentre Colonic Endoscopic Mucosal Resection Study
Completed NCT02196649 - Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial N/A
Not yet recruiting NCT00996619 - Measuring the Spectrum of Tissues During Endoscopy N/A
Completed NCT00997802 - Japanese National Computed Tomographic (CT) Colonography Trial N/A
Completed NCT00468455 - Post-Op Quality of Life After Colorectal Surgery N/A
Completed NCT00018551 - Chemoprevention With Folic Acid Phase 2
Recruiting NCT02552017 - Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities N/A
Completed NCT01979458 - Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon N/A
Unknown status NCT01101672 - Trial for Single Port Versus Conventional Laparoscopic Colectomy Phase 2/Phase 3
Terminated NCT01458925 - Feasibility of Check-Cap's P1 Capsule System Screening N/A
Recruiting NCT05737017 - The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet) N/A
Recruiting NCT02760381 - Acetic Acid for Optical Characterization of Colonic Polyps N/A
Withdrawn NCT04253990 - Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp N/A
Completed NCT01761279 - High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study N/A