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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01901510
Other study ID # 12-009897
Secondary ID
Status Completed
Phase Phase 1
First received June 3, 2013
Last updated March 2, 2015
Start date May 2013
Est. completion date July 2014

Study information

Verified date March 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 75 Years
Eligibility 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

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


Intervention

Drug:
Chromoendoscopy (Indigo Carmine)
Indigo Carmine will be added to the colonic prep to attempt indirect 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.

Locations

Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose of indigo carmine needed to provide adequate chromoendoscopy of the right sided colon The dose in Indigo Carmine in mg per 1/8 - 1/2 gallon needed to provide adequate staining of the cecum and ascending colon. 24 hours Yes
Secondary Cecal intubation rate 24 hours No
Secondary Time to cecal intubation 24 hours No
Secondary Withdrawal time 24 hours No
Secondary Quality of bowel preparation 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.
= 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.
= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
24 hours No
Secondary Patient tolerance of indigo carmine solution 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
30 days Yes
Secondary Quality of staining of the entire colon 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.
24 hours No
Secondary Adenoma detection rate 2 weeks No
Secondary Total number of non rectal serrated polyps detected 2 weeks No
Secondary Total number of sessile serrated adenoma detected 2 weeks No
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