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Trial record 1 of 1 for:    01937429
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Effectiveness of Instillation of Blue Water (Indigo Carmin®) for Colonoscopy (GRAND BLEU)

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ClinicalTrials.gov Identifier: NCT01937429
Recruitment Status : Unknown
Verified September 2013 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : September 9, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE September 4, 2013
First Posted Date  ICMJE September 9, 2013
Last Update Posted Date September 9, 2013
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
The rate of colonoscopy with at least one adenoma detected (or adenoma detection rate) confirmed by a histological reporting. [ Time Frame: Within the first 20 days after colonoscopy. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
  • Measure 1: The characteristics of the lesions detected by the two types of colonoscopy (diameter, macroscopic appearance, histological nature) [ Time Frame: within the first 20 days after colonoscopy. ]
    We chose three classifications recognized by the medical field:
    1. The Paris endoscopic classification defines macroscopic appearance.
    2. The Kudo classification explains endoscopic appearance.
    3. The Vienna classification describes the histologic nature of the lesions.
  • Measure 2 Comparison of the time of the endoscope during the colonoscopy between the two methods [ Time Frame: This data is available during the colonoscopy ]
  • Measure 3 The comparison of the tolerance of the two colonoscopy procedures by assessing patient reported side effects. [ Time Frame: At patient's awakening the day of colonoscopy or one day after ]
    Tolerance is measured using a Visual Analog Scale. The questionnaire includes four questions :
    • Did you have any pains?
    • How would you describe your bloating?
    • How would you describe your sensations of abdominal discomfort?
    • How would you describe your overall tolerance of the examination?
    In addition to this Visual Analog Scale, we administer a short multiple choice questionnaire:
    • Would you be ready to redo the colonoscopy in the same conditions? (yes or no)
    • For patients who have already had colonoscopies with insufflation of air in the past, which examination (tepid water or air) would you prefer during the next exam?
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Instillation of Blue Water (Indigo Carmin®) for Colonoscopy
Official Title  ICMJE GRAND BLEU Study: Does the Colonoscopy With Instillation of Blue Water (Indigo Carmin® Dilute) Enable an Improved Rate of Adenoma Detection for Colonoscopy With Insufflation of Air?
Brief Summary

The colonoscopy is the reference examination for the diagnosis of neoplastic lesions in the colon and rectum. Mass screening assessment studies have shown that colonoscopic detection and removal of adenomas in patients selected through fecal occult blood test reduces colorectal cancer incidence and mortality. However, the literature has reported interval cancer cases or adenomas, probably "missed" by the colonoscopy. In theory, using coloured warm water could improve colon preparation by mobilizing the residual faeces, decreasing the colic spasm and increasing the visualization of the pit pattern. Preliminary American studies, led by Leung et al, have shown a very clear increase in the adenoma detection rate.

The investigators' study involves 1 000 patients, treated in the Rhône-Alpes / Auvergne region. The patients present an indication for colonoscopy following a positive fecal occult blood test or symptoms or personal and family histories of pre-cancerous colonic lesions. They will be randomized into two study groups:one of both groups of study: Group 1: patients undergoing a colonoscopy wtih instillation of tepid water tinged with blue (Indigo Carmin®) Group 2: patients undergoing a standard colonoscopy with insufflation of air. The main objective is to show that the colonoscopy with blue water (Indigo Carmin®) enable detection of more lesions than standard colonoscopy with insufflation of air. The two techniques will be also compared in terms of tolerance, of duration of colonoscopy and type of detected lesions.

In case of improved detection of colorectal lesions, the blue water instillation technique of could dramatically change gastroenterologists' practice by becoming the reference method. The expected clinical benefits are potential revealing of more neoplastic lesions and improvement in abdominal discomfort after colonoscopy.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Adenoma Detection to Prevent Colorectal Cancer
Intervention  ICMJE
  • Device: Colonoscopy with blue Indigo Carmin®
  • Device: Standard colonoscopy with insufflation of air
Study Arms  ICMJE
  • Experimental: Colonoscopy with blue indigo Carmin®
    Patients undergoing from a colonoscopy with instillation of tepid water (30°C) tinged with indigo Carmin® (0,08/1000) during the endoscope insertion from the anus to the caecum, and with insufflation of air only during withdrawal from the caecum to the anus.
    Intervention: Device: Colonoscopy with blue Indigo Carmin®
  • Active Comparator: Standard colonoscopy
    Standard colonoscopy with insufflation of air
    Intervention: Device: Standard colonoscopy with insufflation of air
Publications * Lesne A, Rouquette O, Touzet S, Petit-Laurent F, Tourlonias G, Pasquion A, Rivory J, Aguero Garcete G, Scanzi J, Chalumeau S, Chambon-Augoyard C, Moussata D, Leger-Nguyen F, Degeorges S, Chauvenet M, Fontanges T, Baubet S, Brulet P, Billioud C, Thimonier E, Stroeymeyt-Martin K, Hamel B, Graillot E, Cruiziat C, Scalone O, O'Brien M, Péré-Vergé D, Souquet JC, Phelip JM, Poincloux L, Poupon-Bourdy S, Denis A, Magaud L, Ponchon T, Pioche M. Adenoma detection with blue-water infusion colonoscopy: a randomized trial. Endoscopy. 2017 Aug;49(8):765-775. doi: 10.1055/s-0043-105073. Epub 2017 Apr 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 6, 2013)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients 18 years of age or older
  • Scores 1 to 3 in ASA (American Society of Anesthesiologists) classification
  • Patient having an indication for of colonoscopy to detect colorectal neoplastic lesions, which meet at least one of the following conditions:

    • Positive fecal occult blood Test
    • 1st degree family history of colorectal cancer or adenoma before 60 years of age
    • Personal history of colorectal adenomas or colorectal cancer
    • Unexplained digestive symptoms after 50 years of age or those not responding to symptomatic treatment: modification of bowel movements, abdominal pains
    • Isolated or repeated rectal bleeding after 50 years of age or occult bleeding
    • Acromegaly
    • Infectious endocarditis with digestive bacteria
  • No coagulation anomalies or no taking of medicine affecting coagulation
  • Signing of informed consent form before the performance of any procedure related to the study

Exclusion Criteria:

  • Known inflammatory or infectious colorectal disease
  • Hereditary Non Polyposis Colorectal Cancer disease (Lynch syndrome) or family history of adenomatous polyposis
  • Histories of colorectal surgical resection
  • Known hypersensitivity to indigo Carmin® or to one of the preparation components
  • Pregnant or breastfeeding women, or those likely to become pregnant without effective contraception
  • patient not affiliated with a social security care system or who do not benefit from such a system
  • Patient over 18 years of age protected by the Law, under guardianship or curators
  • Concomitant participation in an interventional biomedical research trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01937429
Other Study ID Numbers  ICMJE 2012.713
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thierry PONCHON, MD Hôpital E. Herriot -Service d'hépato-gastroentérologie
PRS Account Hospices Civils de Lyon
Verification Date September 2013

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