Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Postoperative endoscopic recurrence
研究概览
简要总结
Crohn's disease (CD) (> 200,000 patients in France) is a chronic inflammatory disease that can lead to progression of intestinal destruction and impaired quality of life. Despite the widespread use of biotherapies, intestinal resections remain frequent (50% of patients over time). Unfortunately, surgery is not curative since 75% of patients experienced post-endoscopic operative recurrence (POR) (i.e., recurrence of ulcerations) during the first year after surgery. Prevention of endoscopic POR (defined as a Rutgeerts index ≥ i2) is essential because endoscopic POR is highly predictive of clinical POR (i.e., recurrence of CD-related symptoms): > 40% and > 80% within 5 years for a Rutgeerts index ≥ i2 or ≥ i3, respectively. The recommended management is to start treatment after surgery to avoid endoscopic POR, and to perform a colonoscopy at 6 months (M6) with therapeutic escalation if endoscopic POR. Despite anti-TNF or ustekinumab treatment, the endoscopic POR rate remains high (30-40% at M6) leading to > 40% clinical POR despite therapeutic escalation (90 mg/4 weeks with ustekinumab) potentially due to late therapeutic escalation. Innovative strategies are therefore needed to prevent endoscopic POR, such as the use of fecal calprotectin, a non-invasive biomarker associated with endoscopic CD activity. We have previously demonstrated that its variation between surgery and M3 allows for a value at M3 predictive of endoscopic POR at M6. In this study, we hypothesize, for the first time, that a strategy integrating fecal calprotectin measurement at M3 with earlier therapeutic escalation (M3 vs M6) in case of abnormal value or kinetics could decrease the rate of endoscopic POR at M6.
详细描述
This is a prospective, open-label, multicenter, randomized, controlled clinical trial with two parallel arms evaluating an innovative approach to standard care in patients with Crohn's disease. All eligible patients will be offered the study consecutively by the principal investigator or any other co-investigator declared for the study.
During the pre-inclusion visit (weeks -4 to -0 before inclusion), after verification of inclusion and exclusion criteria and obtaining informed consent, blood tests and an abdominal ultrasound (if participating in the DESTINY-echo ancillary study) will be ordered (pre-biotherapy assessment, CRP) as well as a fecal calprotectin test.
After re-verification of inclusion and exclusion criteria, at the inclusion visit (V0), patients will be randomized to the two study arms (standard arm vs. active arm). Randomization will be stratified by center and number of risk factors. The outcome of this randomization will be known to both the investigator and the patient.
The reference arm will be based on daily practice, i.e., regular follow-up (weeks 0 and 24) with fecal calprotectin measurement at week 10.
Each patient will be seen with a stool sample at weeks 0, 10, and 24. However, the results will only be provided for patients in the active arm. The fecal calprotectin measurement result at week 10 for patients in the standard arm will not be known during the study but may be disclosed upon patient completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients with an established diagnosis of CD according to ECCO guidelines
- •Adult Crohn's disease (age ≥ 18 years)
- •Having undergone ileal, colonic, or ileocolonic resection without residual macroscopic lesions
- •With an anastomosis that can be reached by ileocolonoscopy
- •With at least one of the following risk factors for endoscopic POR: active smoking, previous intestinal resection (before the current resection), length of resected small bowel > 30 cm, fistulizing phenotype (B3 according to the Montreal classification), exposure to at least two biotherapies before surgery
- •No contraindication to ustekinumab treatment
- •Patient capable of giving consent
- •Patient covered by the French healthcare system
排除标准
- •Permanent stoma
- •Total colectomy
- •Uncontrolled postoperative infectious complication
- •Pregnant or breastfeeding women: a pregnancy test will be performed for women of childbearing age
- •Refusal to participate in the study
- •Persons deprived of their liberty by judicial or administrative decision
- •Vulnerable protected adults (under guardianship, curatorship, or legal protection)
研究组 & 干预措施
Active arm
Early dosage of fecal calprotectin at 3 months
干预措施: Early faecal calprotectin dosage (Biological)
结局指标
主要结局
Postoperative endoscopic recurrence
时间窗: 6 months post-operative
Postoperative endoscopic recurrence at 6 months, defined by a Rutgeerts index ≥ i2. This primary endpoint will be defined by endoscopic procedure at 6 months postoperatively.
次要结局
未报告次要终点