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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the endoscopic MAYO score in patients with UC.
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
standart endoscopy
Intervention: 2 standard endoscopy during anti-TNFalpha or vedolizumab treatment
干预措施: standard endoscopy (Device)
PillCamCOLON (C2)
Intervention : 2 PillCamCOLON (C2) during anti-TNFalpha or vedolizumab treatment
干预措施: PillCamCOLON (C2) (Device)
结局指标
主要结局
Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the endoscopic MAYO score in patients with UC.
时间窗: week 12 (W12)
MAYO endoscopic score established by PillCamCOLON (C2) and conventional endoscopy of the common recto-colonic segment explored at week 12 (W12).
次要结局
- Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of the UCEIS scores during an anti-TNF alpha or vedolizumab treatment(Week 12)
- Presence of lesions upstream of the left colonic flexure using PillCamCOLON (C2), when recto-sigmoidoscopy is the conventional endoscopic procedure used.(Week 12)
- Reproducibility inter and intraobserver for the lesions' detection and for the severity grading by PillCamCOLON (C2)(Week 12)
- Analog visual scale (AVS) the preference of the patients and their acceptability of each of 2 examinations(Week 12)
- Adverse events due to PillCamCOLON (C2) and conventional endoscopy(Week 14)
- Capacity of PillCamCOLON (C2) to define the extent of UC, as compared with colonoscopy(Week 12)
- Concordance between PillCamCOLON (C2) and conventional endoscopy for evaluation of the UCEIS score in patients with UC.(Week 12)
- Concordance between PillCamCOLON (C2) and conventional endoscopy for measuring the variation of Mayo scores during an anti-TNF alpha or vedolizumab treatment(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)
- Level of adequate colonic preparation during examinations with PillCamCOLON (C2).(Week 12)
- Correlation between calprotectin level in fecal sample and disease activity.(Week 12)
- Percentage of complete exploration by PillCamCOLON (C2)(Week 12)
研究者
Dr. Arnaud Bourreille
MD
Société Française d'Endoscopie Digestive