Adenoma Detection to Prevent Colorectal Cancer Clinical Trial
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 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic