Adenoma Detection to Prevent Colorectal CancerPhase 3GRAND BLEUNCT01937429
Effectiveness of Instillation of Blue Water (Indigo Carmin®) for Colonoscopy
A Phase 3 study testing Colonoscopy with blue Indigo Carmin® and Standard colonoscopy with insufflation of air in people with Adenoma Detection to Prevent Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoma Detection to Prevent Colorectal Cancer
- What is being tested?
- Colonoscopy with blue Indigo Carmin® and Standard colonoscopy with insufflation of air
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Edouard Herriot
Lyon, 69437
Mathieu PIOCHE, MD, 04.72.11.01.45 ext. +33, mathieu.pioche@chu-lyon.fr
Laurent MAGAUD, CRA, 04 72 11 51 64 ext. +33, laurent.magaud@chu-lyon.fr
About this study
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.
- Being tested
- Colonoscopy with blue Indigo Carmin®, Standard colonoscopy with insufflation of air
- Keywords
- Colonoscopy - Chromoendoscopy - Indigo Carmin® - Adenoma detection - Tepid water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with blue Indigo Carmin®Device
Standard colonoscopy with insufflation of airDevice
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy with blue indigo Carmin® | Experimental | 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. Receives: Device: Colonoscopy with blue Indigo Carmin® |
| Standard colonoscopy | Active comparator | Standard colonoscopy with insufflation of air Receives: Device: Standard colonoscopy with insufflation of air |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of colonoscopy with at least one adenoma detected (or adenoma detection rate) confirmed by a histological reporting.
Measured: Within the first 20 days after colonoscopy.
Secondary outcomes (3)
Measure 1: The characteristics of the lesions detected by the two types of colonoscopy (diameter, macroscopic appearance, histological nature)
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.
Measured: within the first 20 days after colonoscopy.
Measure 2 Comparison of the time of the endoscope during the colonoscopy between the two methods
Measured: 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.
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?
Measured: At patient's awakening the day of colonoscopy or one day after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenoma Detection to Prevent Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry PONCHON, MD, Principal investigator, Hôpital E. Herriot -Service d'hépato-gastroentérologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937429
- Sponsor's protocol ID
- 2012.713
- Acronym
- GRAND BLEU
- Status last verified
- Sep 2013
- First submitted
- 4 Sep 2013
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
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, 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.
PubMed 28399611
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01937429
- Acronym / sponsor ID
- GRAND BLEU / 2012.713
- Keywords
- Colonoscopy - Chromoendoscopy - Indigo Carmin® - Adenoma detection - Tepid water
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy with blue indigo Carmin® | Experimental | Device: 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. |
| Standard colonoscopy | Active comparator | Device: Standard colonoscopy with insufflation of airStandard colonoscopy with insufflation of air |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopy with blue Indigo Carmin® | Device | Colonoscopy with blue indigo Carmin® |
| Standard colonoscopy with insufflation of air | Device | Standard colonoscopy |
Primary outcome
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.
3 secondary outcomes
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Derived from this study: PubMed 28399611Lesne 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry PONCHON, MD principal investigator
Hôpital E. Herriot -Service d'hépato-gastroentérologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colonoscopy with blue Indigo Carmin® and Standard colonoscopy with insufflation of air in people with Adenoma Detection to Prevent Colorectal Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu PIOCHE, MD (04.72.11.01.45 ext. +33, mathieu.pioche@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01937429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.