Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep

NCT01901510 | Completed Phase 1

• 1 other identifier: 12-009897
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps

Keywords

polyp

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Cecal intubation rate

  24 hours

• Time to cecal intubation

  24 hours

• Withdrawal time

  24 hours

• Quality of bowel preparation

  24 hours

• Patient tolerance of indigo carmine solution

  30 days

Study Arms (2)

chromoendoscopy

ACTIVE COMPARATOR

The intervention arm will have Indigo carmine added to the colonic preperation to perform chromoendoscopy

Drug: Chromoendoscopy (Indigo Carmine)

Control

OTHER

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

Interventions

Chromoendoscopy (Indigo Carmine) DRUG

Indigo Carmine will be added to the colonic prep to attempt indirect chromoendoscopy

Also known as: Indirect chromoendoscopy, Colonoscopy

chromoendoscopy

Control OTHER

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.

Control

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Colonic Polyps; Polyps

Interventions

Indigo Carmine; Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• M Harrison, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: July 17, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-03

Locations

US (1)