Probe-based Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis: Development and Validation of the ENHANCE Score
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Inflammation assessment by pCLE videos and standard histology
研究概览
简要总结
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
详细描述
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.
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosis of UC established at least for three months, according to the Lennard-Jones' criteria. Two sub-groups will be studied as follows;
- •Group 1 (n=70) = UC in remission regardless of the medication that allowed remission nor taken by the patient (Mayo' sub-score 0 or 1) and who require colonoscopy regardless of the study according to current guidelines (screening for dysplasia, monitoring during treatment etc).
- •Group 2 (n=30) = Active UC (Mayo' sub-score 2 or 3) requiring adalimumab and for whom a rectosigmoidoscopy should be performed 8 weeks after starting therapy, according to current french guidelines. Eight weeks after the treatment is the minimum time necessary to evaluate the effects of this treatment according the current practice in France. Then, investigators chose in our study to assess the effects in the group 2 at 8 weeks. All the 30 patients in group 2 will receive adalimumab and they will be treatment-naïve patients.
- •Informed consent obtained from the patient
排除标准
- •Allergy to fluorescein
- •Pregnancy
- •Refusal to participate to the study or inability to consent
结局指标
主要结局
Inflammation assessment by pCLE videos and standard histology
时间窗: 6 months
Inflammation will be present if ONE or MORE of the following criteria will be showed by the pCLE examination (the number of criteria will be defined "a posteriori" after comparison with the histological results): * crypt: : number (0-10), size (10 to 200 micrometers), distance between 2 crypts (increase or normal) * cells : number (0 to 50), color (white or black) * vessels : number, diamter (\> or \< 20 micrometers) * fluoresceine leakage (yes or no)
次要结局
- Changes in pCLE criteria after adalimumab and safety of pCLE(6 or 8 weeks)
研究者
RAHMI Gabriel
Medical Doctor
European Georges Pompidou Hospital