Comparison of PillCamCOLON (C2) Capsule and Standard Endoscopy for the Evaluation of Patients With Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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)

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Device: standard endoscopy
* Device: PillCamCOLON (C2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient between 18 and 70 years old Patient with UC requiring treatment with anti-TNFalpha or vedolizumab Patient affiliated to a social security scheme Patient able to understand and follow the study instructions Patient having signed an informed consent form Exclusion Criteria: Patient with severe and acute colitis Patient with Crohn's disease or non-classified colitis Patient with an indication for surgical management of UC Patient with a history of sub-total or total colectomy, or with colostomy or ileostomy. Patient with a history of intestinal irradiation Patient with a known or suspected intestinal stricture Patient with clinical signs suggestive of intestinal stricture Patient with dysphagia with choking on solid food or swallowing disorders Patient with a contra-indication for an anti TNFalpha treatment Patient with a contra-indication for conventional endoscopy (colonoscopy or recto-sigmoidoscopy) Patient with congestive heart failure or severe renal impairment Patient with a pacemaker or other implanted electronic medical device Patient participating in another interventional clinical trial Pregnant or nursing woman Vulnerable individuals: persons deprived of liberty, under tutelage or guardianship

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standart endoscopy<br>Intervention: 2 standard endoscopy during anti-TNFalpha or vedolizumab treatment | Device: standard endoscopy<br>* standard endoscopy will be either colonoscopy or rectosigmoidoscopy<br>|
| Experimental: PillCamCOLON (C2)<br>Intervention : 2 PillCamCOLON (C2) during anti-TNFalpha or vedolizumab treatment | Device: PillCamCOLON (C2)<br>* PillCamCOLON (C2) is a colon video-capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the endoscopic MAYO score in patients with UC. | MAYO endoscopic score established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colonic segment explored at week 12 (W12). | week 12 (W12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the UCEIS score in patients with UC. | UCEIS endoscopic score established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colonic segment explored at D0 and W12. | Week 12 | 
| Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of Mayo scores during an anti-TNF alpha or vedolizumab treatment | Mayo endoscopic scores established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colic segment explored at D0 versus W12 | Week 12 | 
| Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of the UCEIS scores during an anti-TNF alpha or vedolizumab treatment | UCEIS endoscopic scores established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colic segment explored at W12 | Week 12 | 
| Presence of lesions upstream of the left colonic flexure using PillCamCOLON (C2), when recto-sigmoidoscopy is the conventional endoscopic procedure used. | Description of lesions located upstream of the left colonic flexure in terms of their localization and severity (in particular, ulcerations) visualized by PillCamCOLON (C2) when recto-sigmoidoscopy is the conventional endoscopic procedure used (at W12). | Week 12 | 
| Capacity of PillCamCOLON (C2) to define endoscopic mucosal healing (MAYO score 0 and 1) as compared with recto-sigmoidoscopy, during treatment with anti-TNFalpha or vedolizumab. |  | Week 12 | 
| Correlation between calprotectin level in fecal sample and disease activity. | Calprotectin levels in fetal sample | Week 12 | 
| Level of adequate colonic preparation during examinations with PillCamCOLON (C2). | Measurement of the quality of colonic preparation, relative to the commonly used scale, using all PillCamCOLON (C2) films obtained. | Week 12 | 
| Reproducibility inter and intraobserver for the lesions' detection and for the severity grading by PillCamCOLON (C2) | Reproducibility inter and intraobserver concerning the lesions descriptions and their severity. | Week 12 | 
| Analog visual scale (AVS) the preference of the patients and their acceptability of each of 2 examinations | AVS on exams acceptability between PillCamCOLON (C2) and conventional endoscopy | Week 12 | 
| Adverse events due to PillCamCOLON (C2) and conventional endoscopy | To evaluate the tolerance of these two endoscopic examination procedures. Adverse events due to PillCamCOLON (C2) and adverse events due to conventional endoscopy. | Week 14 | 
| Capacity of PillCamCOLON (C2) to define the extent of UC, as compared with colonoscopy |  | Week 12 | 
| Percentage of complete exploration by PillCamCOLON (C2) |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic capsule, ulcerative colitis, mucosal healing, endoscopic score