Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyps
• Intervention / Treatment: Drug: Chromoendoscopy (Indigo Carmine); Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Colonoscopy; Indirect chromoendoscopy
Other: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cecal intubation rate		24 hours
Time to cecal intubation		24 hours
Withdrawal time		24 hours
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
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
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
Adenoma detection rate		2 weeks
Total number of non rectal serrated polyps detected		2 weeks
Total number of sessile serrated adenoma detected		2 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: M Harrison, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: July 16, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: polyp
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: 12-009897