Clinical trial NCT01937429: Effectiveness of Instillation of Blue Water (Indigo Carmin®) for Colonoscopy
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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Adenoma Detection to Prevent Colorectal Cancer
Keywords: Colonoscopy - Chromoendoscopy - Indigo Carmin® - Adenoma detection - Tepid water
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: The rate of colonoscopy with at least one adenoma detected (or adenoma detection rate) confirmed by a histological reporting.
timeFrame: Within the first 20 days after colonoscopy.
Secondary outcomes:
measure: Measure 1: The characteristics of the lesions detected by the two types of colonoscopy (diameter, macroscopic appearance, histological nature)
timeFrame: within the first 20 days after colonoscopy.
measure: Measure 2 Comparison of the time of the endoscope during the colonoscopy between the two methods
timeFrame: This data is available during the colonoscopy
measure: Measure 3 The comparison of the tolerance of the two colonoscopy procedures by assessing patient reported side effects.
timeFrame: At patient's awakening the day of colonoscopy or one day after
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
affiliation: Hôpital E. Herriot -Service d'hépato-gastroentérologie
name: Thierry PONCHON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Pere-Verge 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.