Effectiveness of Instillation of Blue Water (Indigo Carmin®) for Colonoscopy (GRAND BLEU)
Recruitment status was: Recruiting
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.
|Adenoma Detection to Prevent Colorectal Cancer||Device: Colonoscopy with blue Indigo Carmin® Device: Standard colonoscopy with insufflation of air||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||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?|
- 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. ]
- 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:
- The Paris endoscopic classification defines macroscopic appearance.
- The Kudo classification explains endoscopic appearance.
- 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?
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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.
|Device: Colonoscopy with blue Indigo Carmin®|
Active Comparator: Standard colonoscopy
Standard colonoscopy with insufflation of air
|Device: Standard colonoscopy with insufflation of air|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01937429
|Contact: Mathieu PIOCHE, MD||04.72.11.01.45 ext +firstname.lastname@example.org|
|Contact: Laurent MAGAUD, CRA||04 72 11 51 64 ext +email@example.com|
|Hôpital Edouard Herriot||Recruiting|
|Lyon, France, 69437|
|Contact: Mathieu PIOCHE, MD 04.72.11.01.45 ext +33 firstname.lastname@example.org|
|Contact: Laurent MAGAUD, CRA 04 72 11 51 64 ext +33 email@example.com|
|Principal Investigator:||Thierry PONCHON, MD||Hôpital E. Herriot -Service d'hépato-gastroentérologie|