Ulcerative Colitis Clinical Trial
Official title:
Comparison of the PillCamCOLON (C2) Capsule With Standard Endoscopy for the Evaluation of the Severity and the Endoscopic Healing of Patients With Ulcerative Colitis (UC)
Ulcerative colitis (UC) is an inflammatory bowel disease progressing through flare-ups. The
therapeutic objective, which was originally based on clinical remission, is currently
evolving with the development of biotherapies towards the achievement of endoscopic
remission. Current recommendations for therapeutic management advocate the achievement of
endoscopic mucosal healing (EMH), with an observed decrease in the necessity for colectomy
in the case of EMH. Endoscopic evaluation of the severity of UC is performed during a
digestive endoscopy (colonoscopy for a complete colonic exploration, or recto-sigmoidoscopy
for a partial exploration of the colon) from endoscopic activity scores adapted for UC.
Currently, the score the most commonly used is the MAYO endoscopic score. This is a global
score of increasing intensity from 0 to 3, taking into account the following basic lesions:
vascular pattern, granularity or/and friability of the mucosa, spontaneous bleeding, erosion
and ulceration. However this score has limits: it does not distinguish deep cavitating
ulcerations with mucous detachment from simple ulcerations which have a better prognosis.
A new endoscopic score specific for UC has been developed and is currently being validated.
It is termed Ulcerative Colitis Endoscopic Index of Severity (UCEIS). This evaluation takes
into account the three most reproducible factors - the vascular pattern, the presence of
bleeding, and erosions or ulcerations including cavitating ulceration - in the total score.
To ensure optimal patient care and an adaptation of the therapeutic medical care to the
endoscopic severity of the disease, endoscopic exploration should be performed recurrently.
However, this exploration is an invasive procedure, requires general anaesthesia for
colonoscopy, and can lead to potential complications such as perforation. This explains the
poor acceptance by patients, resulting in a sub-optimal therapeutic support.
For each patient, the study will be conducted in accordance with the following schedule:
Information/inclusion visit: D-30 (± 30 days)
- Full information about the trial
- Verification of inclusion and non-inclusion criteria
- Acquisition of informed consent (either the same day or after a period of reflexion)
- Medical and surgical history
- Clinical examination
Endoscopic visit: D0 On two consecutive days or within a maximum of seven days but
obligatorily before the anti-Tumor Necrosis Factor (TNF) alpha treatment
- Faecal sample (calprotectin)
- Clinical examination
- Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy
(colonoscopy)
-The endoscopic examinations will each be analyzed by a different endoscopist working
in a blinded evaluation. An UC activity score will be calculated depending on two
scores: MAYO and UCEIS.
- Notification of Adverse Event (AE) / Serious Adverse Event (SAE)
Follow-up visit: W12 (12 weeks ± 5 days after D0)
- Faecal sample (calprotectin)
- Clinical examination
- Endoscopic examination by PillCamCOLON (C2) then by conventional endoscopy (coloscopy)
-The endoscopic examinations will each be analyzed by a different endoscopist working
in a blinded evaluation. An UC activity score will be evaluated depending on two
scores: MAYO and UCEIS.
- Notification of AE/SAE
End-of-study visit (possibly by telephone) W14 (± 5 days)
*Notification of AE/SAE
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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