SyMptomAtic Stricturing Small Bowel CRohn's Disease - Medical Treatment Versus Surgery, a Prospective, Multi-centre, Randomized, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- IBD (inflammatory bowel disease) - related quality of life
研究概览
简要总结
The objective of the SMART trial is to compare a combination therapy using azathioprine and subcutaneous infliximab versus ileocecal resection in patients with symptomatic small bowel Crohn's disease.
详细描述
Crohn's disease (CD) is a chronic, disabling and destructive inflammatory bowel disease (IBD) leading to progressive and cumulative bowel damage, including fistulas and strictures. Strictures are defined as intestinal luminal narrowing and can lead to obstructive symptoms in the medium-to-long term. Symptomatic strictures significantly impair patient's quality of life by the presence of obstructive symptoms such as abdominal pain, nausea, vomiting, abdominal distension, and dietary restrictions leading to malnutrition. Strictures can appear anywhere in the gastrointestinal tract, but affect most commonly the terminal ileum. Epidemiological studies indicate that more than 40% of patients with ileal CD will develop strictures.
However, treatment strategies are not well-defined in this indication. Most patients undergo surgery but recent observations indicate that a medical treatment by anti-TNF may be considered in stricturing CD. The European Crohn's Colitis Organization recommends that "ileocecal CD with obstructive symptoms, but no significant evidence of active inflammation, should be treated by surgery". However, the lack of inflammation is difficult to demonstrate and does not predict the extent of fibrosis, and inflammation and fibrosis are often associated. Thus, there is a need for better defining therapeutic strategies.
The objective of the SMART trial is to compare for the first time medical versus surgical approaches in stricturing CD. Indeed, up to date, no randomized controlled trial has been conducted to compare medical treatment alone versus surgery in patients with symptomatic stricturing CD. The hypothesis is that medical treatment by a combination therapy using infliximab and azathioprine is non-inferior to surgical resection in terms of health-related quality of life (HRQoL) at 1 year, with the advantage of being conservative as regards the high rates of post-operative recurrence with the subsequent risk of small bowel syndrome, as well as highly more acceptable by patients, especially since infliximab is now available as a biosimilar in a subcutaneous formulation, which should also improve the cost-effectiveness of the medical strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age between 18 and 70 years
- •Male or female
- •Documented small bowel CD with intestinal stricture(s) identified on CT, MRI or endoscopy, AND responsible for obstructive symptoms
- •CREOLE score > 2
排除标准
- •Adults under guardianship, safeguard justice or trusteeship
- •Pregnant or breastfeeding female
- •Acute bowel obstruction requiring urgent surgical intervention
- •Suspected or confirmed gastrointestinal perforation
- •Concurrent active perianal sepsis
- •Internal fistulizing disease in association with strictures
- •Colonic stenosis and/or colonic active disease at screening endoscopy
- •Contra-indication to surgery, general anesthesia, anti-TNF, thiopurines
- •Use of corticosteroids (prednisolone > 20 mg daily or equivalent) within 4 weeks prior to visit V0
- •Treatment with any biologics within 8 weeks before visit V0
- •Presence of a stoma
- •HIV/HCV/HBV infection
研究组 & 干预措施
Surgery
Intestinal resection
干预措施: Intestinal resection (Procedure)
Medical treatment
Combination therapy with subcutaneous infliximab and azathioprine
干预措施: Azathioprine + infliximab (Drug)
结局指标
主要结局
IBD (inflammatory bowel disease) - related quality of life
时间窗: 12 months
Mean total inflammatory bowel disease questionnaire (IBDQ - Inflammatory Bowel Disease Questionnaire ) score. The total score ranges from 32 to 224, the higher the score the better the quality of life.
次要结局
- Endoscopic remission(6 months)
- Clinical activity(1, 3, 6, 9, 12, 18 and 24 months)
- inflammatory biomarkers (fecal calprotectin)(1, 6, 12, 18 and 24 months)
- IBD (inflammatory bowel disease) -related quality of life(1, 3, 6, 9, 18 and 24 months)
- inflammatory biomarkers ( C-reactive protein [CRP])(1, 6, 12, 18 and 24 months)
- imaging parameters(12 months)
- treatment failures(12 and 24 months)
- patient-reported outcomes (disability)(1, 3, 6, 9, 12, 18 and 24 months)
- patient-reported outcomes (work productivity)(1, 3, 6, 9, 12, 18 and 24 months)
- patient-reported outcomes (fatigue)(1, 3, 6, 9, 12, 18 and 24 months)
- patient-reported outcomes (generic quality-of-life)(1, 3, 6, 9, 12, 18 and 24 months)
- patient-reported outcomes (anxiety/depression)(1, 3, 6, 9, 12, 18 and 24 months)
- Patient's acceptability -patients refusing to be included(24 months)
- intervention-related adverse events(24 months)
- Obstructive symptoms(1, 3, 6, 9, 12, 18 and 24 months)
- patient-reported outcomes (body image)(1, 3, 6, 9, 12, 18 and 24 months)
- patient's acceptability - The reason(24 months)
- efficiency of medical treatment compared to surgery as assessed by a cost-utility analysis performed from a collective perspective(24 months)