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Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01607255
First received: May 24, 2012
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

Adenoma detection rate (ADR) is a quality indicator of colonoscopy performed for colorectal cancer screening. Population studies have shown that traditional air colonoscopy fails to eliminate post screening colonoscopy cancers or cancer mortality in the proximal colon. The investigators aim to establish the superior effectiveness of combining chromoendoscopy with the water exchange method in detecting more proximal diminutive adenomas during screening colonoscopy in sedated veterans. An improved adenoma detection rate associated with optical colonoscopy will minimize the risk of missed lesions. The improvement may translate into a remedy for the limitations of screening colonoscopy in the proximal colon, e.g. a higher adenoma detection rate may minimize the burden of post screening colonoscopy interval colorectal cancers among the veteran population.


Condition Intervention
Colorectal Neoplasms
Drug: Indigo carmine
Procedure: water (exchange) method
Procedure: water (exchange) plus dye method
Procedure: air method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Water & Indigo Carmine vs Water or Air Method

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Proximal diminutive (<10 mm) adenoma detection rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Proximal diminutive adenoma detection rate (ADR) in screening colonoscopy performed with the unusual air method, versus the water (exchange) method and with dye added to the water (exchange) method


Estimated Enrollment: 480
Study Start Date: May 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: water (exchange) method
Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.
Procedure: water (exchange) method
Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.
Experimental: water (exchange) plus dye method
Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions
Drug: Indigo carmine
0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy
Procedure: water (exchange) plus dye method
Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions
Active Comparator: air method
The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.
Procedure: air method
The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.

Detailed Description:
  1. Design: Prospective, single center, patient blinded, randomized controlled trial
  2. Methods: Colonoscopy with traditional air insufflation, water exchange or water exchange plus indigocarmine to aid insertion of colonoscope; split dose bowel preparation; all patients will receive sedation; assessment of serum electrolytes level before and after colonoscopy

    1. Control method: Traditional air insufflation method.
    2. Study methods:

      • Water exchange method.
      • Water method combined with chromoendoscopy (0.008% indigo carmine).
  3. Population to be studied Veterans between age 50 and 75 referred for first time screening colonoscopy
  4. Unit(s) of analysis

    1. Primary outcome: overall adenoma detection rate.
    2. Secondary outcomes: patient demographic variable and procedure related measures.
  5. Sampling strategy: all veterans referred for screening colonoscopy will be offered enrollment in the study.

    1. Sample size calculation. A total of 480 subjects will be recruited and randomized with 160 in each group.

5. Subject recruitment: patients referred for screening colonoscopy come from three sources.

6. Description of base population and groups to be studied and method of randomization.

Veterans between age 50 and 75 referred for first time screening colonoscopy. After informed consent, assignment to control or study arm based on computer generated random number codes stored in pre-arranged opaque envelopes.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • asymptomatic veterans scheduled for first time screening colonoscopy and agree to be randomized will be enrolled.

Exclusion Criteria:

  • patients who decline to be randomized, non screening cases.
  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: NCT01607255

Contacts
Contact: Joseph W Leung (916) 366-5339 Joseph.Leung2@va.gov

Locations
United States, California
VA Northern California Health Care System, Mather, CA Recruiting
Sacramento, California, United States, 95655
Contact: Joseph W Leung    916-366-5339    Joseph.Leung2@va.gov   
Contact: Andrew Yen, MD    (916) 366-5339    Andrew.Yen3@va.gov   
Principal Investigator: Joseph W. Leung         
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph W. Leung VA Northern California Health Care System, Mather, CA
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01607255     History of Changes
Other Study ID Numbers: CLIN-10-11S
Study First Received: May 24, 2012
Last Updated: November 10, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
adenoma detection
screening colonoscopy
water exchange method
chromoendoscopy

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014