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Combined Chromoendoscopy and Water Method for Screening Colonoscopy

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.
ClinicalTrials.gov Identifier: NCT01383265
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : June 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).

Condition or disease Intervention/treatment
Colon Polyp Procedure: Water method and chromoendoscopy Procedure: Water method

Detailed Description:

Background: Warm water infusion in lieu of air insufflation (water method) improves overall success of screening colonoscopy and our retrospective data indicate a higher adenoma detection rate. Dye spray methods to improve neoplastic polyp detection such as targeted staining or pancolonic chromoendoscopy have been described.

Aim: In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).

Methods: After informed consent patients undergoing screening colonoscopy will be randomized to be examined by the study or control method. Study method will employ a 0.008% IC solution. Control method will employ plain water. The water method in both study and control groups will be applied as previously described. The colonoscopy will be performed under sedation. Primary outcome measure: adenoma detection rate; secondary outcome: relevant procedure-related variables.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1177 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Randomized Controlled Trial (RCT) to Compare Adenoma Detection Rate of Combined Chromoendoscopy (Indigo Carmine) With Water Infusion in Lieu of Air Insufflation (Water Method) vs. Water Method Alone in Screening Colonoscopy
Study Start Date : March 2010
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Water method and chromoendoscopy
Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy
Procedure: Water method and chromoendoscopy
Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy
Other Names:
  • Water method
  • Chromoendoscopy
  • Screening colonoscopy
Active Comparator: Water method
Control method will use plain water with the water method for screening colonoscopy
Procedure: Water method
Control method will use plain water with water method for screening colonoscopy
Other Name: Screening colonoscopy


Outcome Measures

Primary Outcome Measures :
  1. Diagnosis of adenoma [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adult (≥50 years old
  • Male and female patients
  • Scheduled for screening colonoscopy
  • Consented and accept randomization to study or control method

Exclusion Criteria:

  • Patients who decline to participate
  • Unable to give informed consent
  • Unable to complete questionnaires due to language or other difficulties
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01383265


Locations
United States, California
Sacramento VA Medical Center
Mather, California, United States, 95655
Sponsors and Collaborators
VA Northern California Health Care System
Investigators
Principal Investigator: Joseph Leung, MD Sacramento VA Medical Center
More Information