Colitis, Ulcerative Clinical Trial
Official title:
Probe-based Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis: Development and Validation of the ENHANCE Score
The aim of the study is to construct and validate an endomicroscopic score correlated with
microscopic inflammation activity in patients with UC.
Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which
offers the possibility to perform in vivo mucosal microscopic analysis in real time during
endoscopy.
Primary Objectives : Development and validation of a UC endomicroscopic score, after
correlation between pCLE data and histological data using the Geboes' score as a gold
standard during ulcerative colitis.
Secondary Objectives:
- Identify predictive factors for the response to adalimumab.
- Identify predictive factors for recurrence in patients with UC in remission (Mayo score
0 or 1).
- Safety of the pCLE procedure
Informed consent will be obtained before colonoscopy that includes the known risks and
benefits related to the procedure according to the standard protocol of the physician and
institution.
A separate informed consent document to participate in the study specific to the approach,
technology will be executed.
1. Operator's training before the beginning of the study
Thirty short pCLE video sequences will be sent to each investigator. Video sequence
contains pCLE images of mucosal inflammation in a patient with UC. For each video the
correlation with histology is known. The investigator will have to recognize the
different pCLE inflammation criteria (Annex 2) and a 90% correct response rate will be
required.
2. Endoscopic procedures
MACROSCOPIC examination: colonoscopy
Bowel preparation according to standard protocol was used for colonoscopy. During the
colonoscopy, the rectal and colonic mucosal will be analysed with high resolution white
light (with or without virtual chromoendoscopy). Before pCLE examination and according to
current guidelines, targeted biopsies will be taken in every suspected area of dysplasia for
specific histological examination.
MICROSCOPIC examination: pCLE (Cellvizio)
pCLE examination will be done after intravenous injection of fluoresceine (2.5 ml), with the
monitoring of cardiovascular and respiratory functions. Three defined area will be analysed:
right colon, left colon (40cm from the anus) and the rectum (10cm). Real time analysis and
re-reading after the colonoscopy will be done for the video sequences recording during the
procedure. A double-blind analysis for each video sequence will be done by two experienced
endoscopists.
Rectal and colonic biopsies
For each location (right colon, left colon and rectum), 4 macroscopic area will be
indentified (anterior, posterior, left and right), recorded (endoscopic images) and the
mucosal inflammation will be scored according to the Mayo's and UCEIS classifications. Then,
the probe using for the pCLE procedure will be applied on these 4 different areas and video
sequences will be recorded ("optical biopsies"). At the end of the procedure, biopsies will
be taken from each area. Each biopsy will have a registration number and the corresponding
pCLE video sequence will be specified.
For each location (right colon, left colon, rectum), the final score of inflammation
(macroscopic or microscopic) will be define by the higher score recorded in the 4 areas
(anterior, posterior, left and righ).
Sensibility to change
For the patients with active UC in group 2 (Mayo' sub-score 2 or 3), a rectosigmoidoscopy
should be performed 8 weeks after starting therapy, according to current french guidelines.
In order to compare the pCLE examination before and after adalimumab therapy in the group 2,
each area will be identified with a submucosal injection of Indian ink.
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