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 April 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: April 3, 2014
Last verified: April 2014

May 24, 2012
April 3, 2014
May 2013
September 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01607255 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparative Efficacy of Water & Indigo Carmine vs. Water or Air Method on Adenoma Detection Rate (ADR) - a Randomized Controlled Trial (RCT)
Comparative Efficacy of Water & Indigo Carmine vs Water or Air Method

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.

  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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Colorectal Neoplasms
  • 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) 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) 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
  • 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.
  • 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.
    Intervention: Procedure: water (exchange) method
  • 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
    Interventions:
    • Drug: Indigo carmine
    • Procedure: water (exchange) plus dye method
  • 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.
    Intervention: Procedure: air method

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
480
September 2015
September 2015   (final data collection date for primary outcome measure)

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.
Both
45 Years to 75 Years
Yes
Contact: Joseph W Leung (916) 366-5339 Joseph.Leung2@va.gov
United States
 
NCT01607255
CLIN-10-11S
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Joseph W. Leung VA Northern California Health Care System, Mather, CA
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP