Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep
Condition: Colonic Polyps
MeSH terms: Colonic Polyps
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Chromoendoscopy (Indigo Carmine); Control
Intervention type(s): Drug; Other
Intervention description(s): Indigo Carmine will be added to the colonic prep to attempt indirect chromoendoscopy; The control will have minimal Indigo Carmine added to the colonic prep. This will serve to color the solution blue for blinding but not enough to provide significant staining for chromoendoscopy.
Other intervention name(s): Indirect chromoendoscopy; Colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: polyp