Combined Chromoendoscopy and Water Method for Screening Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Northern California Health Care System
ClinicalTrials.gov Identifier:
NCT01383265
First received: June 24, 2011
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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 Intervention
Colon Polyp
Procedure: Water method and chromoendoscopy
Procedure: Water method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by VA Northern California Health Care System:

Primary Outcome Measures:
  • Diagnosis of adenoma [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 1177
Study Start Date: March 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Water method
  • Screening colonoscopy

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Responsible Party: VA Northern California Health Care System
ClinicalTrials.gov Identifier: NCT01383265     History of Changes
Other Study ID Numbers: VANCHCS-GI-006
Study First Received: June 24, 2011
Last Updated: June 13, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Northern California Health Care System:
screening colonoscopy
adenoma
water method

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 25, 2014