Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 主要终点
- To evaluate the prevalence of dysplasia in patients with IBD at high risk of preneoplastic lesions followed prospectively in a screening program at the time of high-definition endoscopes.
研究概览
简要总结
Inflammatory Bowel Disease (IBD) patients have an increased risk of ColoRectal Cancer (CRC). The cumulative risk of CRC development is estimated at 1% after 10 years of disease progression, 2% after 20 years, and 5% after more than 20 years of disease progression (1). The incidence of CRC in IBD has gradually declined, attributed to enhanced detection of preneoplastic lesions (dysplasia), improved adherence to screening recommendations, utilization of advanced high-definition endoscopes (2-4), and the implementation of more efficacious therapeutic strategies (5-9).
Presently, there is no consensus on the endoscopic management of dysplastic lesions. Recent techniques such as submucosal dissection (ESD) enable the resection of non-polypoid flat lesions larger than 2 cm. Lesions previously treated with colectomy can now be resected by ESD with en-bloc resection rates of approximately 85.7% (17). However, long-term data on the risk of local or distant recurrence after endoscopic resection in IBD is lacking. It is crucial to evaluate complete (R0) and curative resection rates, as well as the rate of local recurrence, based on the type of endoscopic treatment.
In light of the 21st century advancements, characterized by high-definition endoscopes and targeted treatments, it is imperative to:
- Assess the prevalence and incidence of dysplasia in IBD and its risk of progression to CRC.
- Specifically characterize the endoscopy and histology of pre-neoplastic lesions in IBD to facilitate better selection of lesions amenable to endoscopic treatment or surgery.
- Evaluate the rates of local and distant recurrence over time, considering factors associated with this evolving risk (IBD characteristics, endoscopic appearance, histology, type of resection, etc.).
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
- •Patients age ≥ 18 years
- •Documented diagnosis of CD or UC established based on standard clinical, endoscopic and histological criteria.
- •IBD patients requiring screening colonoscopy for dysplasia as following:
- •IBD (CD/UC) evolving for more than 8 years, or for ≥1 year if associated with Primary Sclerosing Cholangitis (PSC)
- •For UC: Extended ulcerative colitis (E2 or E3 in the Montreal classification)
- •For CD: Colonic (L2) or ileocolonic (L3) Crohn's disease with > 50% involvement of the colon.
- •Patient affiliated to the health security system
- •Patient who has received information about the study by the investigator and agreed to participate.
排除标准
- •Patient followed for ileal Crohn's disease (L1)
- •Patient followed for rectal ulcerative colitis (E1)
- •Patient referred for a therapeutic endoscopic procedure, without prior or subsequent follow-up in the participating center
- •Patients < 18 years old
- •Patient under guardianship or curatorship
- •Patient objects to their personal data being used in the context of research
结局指标
主要结局
To evaluate the prevalence of dysplasia in patients with IBD at high risk of preneoplastic lesions followed prospectively in a screening program at the time of high-definition endoscopes.
时间窗: "From enrollment to the end of study at 7 years"
The primary endpoint is the prevalence of dysplasia in IBD patients at high risk of dysplasia estimated at their first endoscopy in the study.
次要结局
未报告次要终点