Value of Contrast-enhanced Ultrasonography and Magnetic Resonance Enterography to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease Complicated by Symptomatic Small Bowel Stricture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 18
- 主要终点
- % of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..)
研究概览
简要总结
The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has not been clearly demonstrated. The results reported by some teams suggest no beneficial effect or even an increased risk of bowel obstruction in the case of stricture, while other publications indicate a favourable action of anti-TNF in this setting. The efficacy of anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on the lesions responsible for the stricture, as anti-TNF agents are probably effective in inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice, the decision is currently empirical and a trial of anti-TNF therapy is often proposed.
In view of the high incidence of intestinal strictures in CD and the need for a treatment as effective as anti-TNF in this setting, it is important to more clearly define the indications of these treatments guided by the information provided by modern imaging.
The aim of this prospective study is to determine whether certain signs detected by MR enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF therapy in patients with CD presenting a symptomatic stricture of the small bowel and scheduled to receive this treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Crohn's disease defined according to the usual endoscopic, histological, and radiological criteria
- •Small bowel (jejunum or ileum) stricture identified by radiography or endoscopy
- •Obstructive symptoms greater than or equal to 3 on a scale from 0 to 6 evaluated over the last 8 weeks
- •Failure of corticosteroids and/or immunosuppressives and indication for anti-TNF therapy
排除标准
- •Nonresolving complete bowel obstruction
- •Previous anti-TNF therapy
- •Contraindication to anti-TNF therapy:
- •Intra-abdominal, intra-mural or extramural abscess
- •Active infection
- •Severe infection during the previous 2 months
- •Nontreated latent tuberculosis
- •Heart failure
- •Active malignancy during the previous 5 years
- •Demyelinating neurological disease
- •Modification of the treatment of Crohn's disease during the previous two months: azathioprine, mercaptopurine, methotrexate, thalidomide
- •Contraindication to MR enterography or contrast-enhanced ultrasonography
结局指标
主要结局
% of failure defined by the development of at least one of events (obstructive symptoms, activity of the disease..)
时间窗: 6 months minus baseline
次要结局
- Change of the obstructive symptom scale at the various visits between D0 and W24(6 months minus baseline)