Colorectal Neoplasms, Hereditary Nonpolyposis
Conditions
Keywords
Colorectal cancer, HNPCC, Diagnosis, Coloscopy, Chromoscopy, Indigo carmine, Colorectal Neoplasms, Hereditary Nonpolyposis
Brief summary
The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.
Detailed description
Patient with HNPCC syndrome confirmed by a mutation (MLH1, MSH2, MHS1) are involved in the study. Patient have 2 colonoscopy back to back. The second coloscopy is associated to chromoscopy with carmin indigo. Endoscopist are randomised for the colonoscopy with chromoscopy and are un-awarded of the result of the first colonoscopy. Histopathology of the polyp are noted. The follow up were 1 month.
Interventions
PROCEDUREColonoscopy with chromoscopy
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with MLH1, MSH2 or MSH6 mutation. * Patients concerned by early detection colonoscopy.
Exclusion criteria
* Coloscopy of tracking since less 1an * occlusive Syndrome contra-indicating the preparation for a total coloscopies * Colectomies * medical Conditions or serious illnesses contra-indicating a coloscopy of screening * pregnant Woman or nursing * Anomaly of coagulation contra-indicating the realization of biopsies and/or the exeresis of the lesion colorectal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of pre-cancer lesions or early cancer detected. | during the procedure |
Secondary
| Measure | Time frame |
|---|---|
| Anatomopathologic criteria (size of lesions, …). | during the procedure |
Countries
France
Outcome results
None listed