Trial record 6 of 264 for:    Open Studies | colonoscopy

Effectiveness of Instillation of Blue Water (Indigo Carmin®) for Colonoscopy (GRAND BLEU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01937429
First received: September 4, 2013
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Adenoma Detection to Prevent Colorectal Cancer
Device: Colonoscopy with blue Indigo Carmin®
Device: Standard colonoscopy with insufflation of air
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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?

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    We chose three classifications recognized by the medical field:

    1. The Paris endoscopic classification defines macroscopic appearance.
    2. The Kudo classification explains endoscopic appearance.
    3. 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

    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?


Estimated Enrollment: 1000
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937429

Contacts
Contact: Mathieu PIOCHE, MD 04.72.11.01.45 ext +33 mathieu.pioche@chu-lyon.fr
Contact: Laurent MAGAUD, CRA 04 72 11 51 64 ext +33 laurent.magaud@chu-lyon.fr

Locations
France
Hôpital Edouard Herriot Recruiting
Lyon, France, 69437
Contact: Mathieu PIOCHE, MD    04.72.11.01.45 ext +33    mathieu.pioche@chu-lyon.fr   
Contact: Laurent MAGAUD, CRA    04 72 11 51 64 ext +33    laurent.magaud@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Thierry PONCHON, MD Hôpital E. Herriot -Service d'hépato-gastroentérologie
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01937429     History of Changes
Other Study ID Numbers: 2012.713
Study First Received: September 4, 2013
Last Updated: September 6, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hospices Civils de Lyon:
Colonoscopy - Chromoendoscopy - Indigo Carmin® - Adenoma detection - Tepid water

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014