- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01937429
Effectiveness of Instillation of Blue Water (Indigo Carmin®) for Colonoscopy (GRAND BLEU)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Lyon, France, 69437
- Recruiting
- Hôpital Edouard Herriot
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Contact:
- Mathieu PIOCHE, MD
- Phone Number: +33 04.72.11.01.45
- Email: mathieu.pioche@chu-lyon.fr
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Contact:
- Laurent MAGAUD, CRA
- Phone Number: +33 04 72 11 51 64
- Email: laurent.magaud@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Active Comparator: Standard colonoscopy
Standard colonoscopy with insufflation of air
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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Within the first 20 days after colonoscopy.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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We chose three classifications recognized by the medical field:
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within the first 20 days after colonoscopy.
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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
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This data is available during the colonoscopy
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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
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Tolerance is measured using a Visual Analog Scale. The questionnaire includes four questions :
In addition to this Visual Analog Scale, we administer a short multiple choice questionnaire:
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At patient's awakening the day of colonoscopy or one day after
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thierry PONCHON, MD, Hôpital E. Herriot -Service d'hépato-gastroentérologie
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012.713
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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