Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep

Colonic Polyps Clinical Trial

Official title:

Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901510
• Other study ID #: 12-009897
• 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

• Colonic Polyps

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