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Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01901510
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):
M. Edwyn Harrison, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Drug: Chromoendoscopy (Indigo Carmine) Other: Control Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep
Study Start Date : May 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

Arm Intervention/treatment
Active Comparator: chromoendoscopy
The intervention arm will have Indigo carmine added to the colonic preperation to perform chromoendoscopy
Drug: Chromoendoscopy (Indigo Carmine)
Indigo Carmine will be added to the colonic prep to attempt indirect chromoendoscopy
Other Names:
  • Indirect chromoendoscopy
  • Colonoscopy

The control arm will have minimal Indigo carmine added to the colonic prep in a concentration which will not be enough to perform chromoendoscopy
Other: Control
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.

Primary Outcome Measures :
  1. Dose of indigo carmine needed to provide adequate chromoendoscopy of the right sided colon [ Time Frame: 24 hours ]
    The dose in Indigo Carmine in mg per 1/8 - 1/2 gallon needed to provide adequate staining of the cecum and ascending colon.

Secondary Outcome Measures :
  1. Cecal intubation rate [ Time Frame: 24 hours ]
  2. Time to cecal intubation [ Time Frame: 24 hours ]
  3. Withdrawal time [ Time Frame: 24 hours ]
  4. Quality of bowel preparation [ Time Frame: 24 hours ]

    The Boston Bowel Preparation Scale will be used to grade the quality of the colonic prep:

    0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.

    1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
    2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
    3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.

  5. Patient tolerance of indigo carmine solution [ Time Frame: 30 days ]

    The rate side effects experienced in the active arm versus the control arm will be compared to determine if side effects experienced are different in both groups. Known common side effect from the Polyethylene based colonic preparation include:

    Malaise Abdominal distension Anal irritation Nausea Abdominal pain Vomiting Rigors Thirst

  6. Quality of staining of the entire colon [ Time Frame: 24 hours ]

    Chromoendoscopy quality:

    Scoring for 3 areas of the colon will be recorded separately:

    Right sided, transverse, left sided Distribution of staining in each area: 0 none, covering less than 50% = 1, patchy covering more than 50%=2, staining most of the mucosa (>80%) =3

    Intensity of staining: none = 0, poor= 1, fair =visible but not obscuring the vasculature, good= visible and obscuring the vasculature.

  7. Adenoma detection rate [ Time Frame: 2 weeks ]
  8. Total number of non rectal serrated polyps detected [ Time Frame: 2 weeks ]
  9. Total number of sessile serrated adenoma detected [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Patients presenting for screening or surveillance colonoscopy
  • Must be aged 50 to 75 yrs
  • Must be able and willing to sign informed consent

Exclusion criteria:

  • Known Creatinine >1.2
  • Cirrhosis
  • Pregnancy or breast feeding
  • History of anaphylaxis to any dye
  • History of bowel surgery or small bowel obstruction
  • History of aspiration
  • History of dysphagia
  • American Society of Anesthesia class >2
  • History of abnormal liver function test in the last year
  • History of any degree of cytopenia in the last year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01901510

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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: M Harrison, MD Mayo Clinic

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Responsible Party: M. Edwyn Harrison, PI, Mayo Clinic Identifier: NCT01901510     History of Changes
Other Study ID Numbers: 12-009897
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015
Keywords provided by M. Edwyn Harrison, Mayo Clinic:
Additional relevant MeSH terms:
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Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps