The St. Paul's Hospital Advanced Endoscopic Resection Centre Cohort for Colorectal Neoplasia (SPARC-C): A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,500
- 试验地点
- 9
- 主要终点
- Clinical Success of Endoscopic Procedure
研究概览
简要总结
The SPARC-C study is a prospective, multi-institutional observational study of patients referred for the management of large (≥ 20mm) non-pedunculated colorectal polyps (LNPCPs). Patients are managed consistent with current standards of care. Prospectively collected data includes: patient clinicodemographic details, lesion details, procedural details, and clinical outcomes.
详细描述
Endoscopic resection techniques, including endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), and cold snare resection (CSR), have become the primary treatment strategy for the vast majority of large non-pedunculated colorectal polyps (LNPCPs). This is because of the efficacy, safety, and cost-effectiveness of endoscopic techniques compared to surgery. Site-specific technical modifications and the development of auxiliary techniques/strategies have mitigated the risk of technical failure, clinically significant post-resection bleeding (CSPEB), significant deep mural injury (S-DMI)/perforation, and recurrence. However, questions still remain about the application and selection of these techniques.
This is a prospective, multicentre cohort study of consecutive patients referred to an interventional endoscopist with a tertiary referral practice in minimally invasive endoscopic resection techniques for the management of a LNPCP. This study will be based at St. Paul's Hospital (and its affiliated sites), Vancouver General Hospital, and collaborating sites, with the aim of enrolling 3500 participants over 10 years.
This cohort serves as a platform to continue refining the management of LNPCPs. We will evaluate LNPCP management outcomes, including technical success, clinical success, clinically significant intra-procedural bleeding (CSIPB), S-DMI, CSPEB, delayed perforation, recurrence, and referral to surgery. Findings will also help to further refine mitigating strategies for intra-procedural and post-procedural adverse outcomes (CSPIB, S-DMI, CSPEB, delayed perforation, recurrence, and referral to surgery). Finally, we aim to optimize the application of minimally invasive endoscopic resection techniques for the management of LNPCPs, including the development of artificial intelligence clinical decision support solutions (AI-CDSS).
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 ≥ 18 years of age referred for the management of an LNPCP
- •Able to provide informed consent.
排除标准
- •Unable to provide informed consent
- •Pregnant or lactating women.
研究组 & 干预措施
Large non-pedunculated colorectal polyp (LNPCP)
Patients referred to St. Paul's Hospital for endoscopic management of a large (≥20mm) non-pedunculated colorectal polyp (LNPCP).
干预措施: Endoscopic tissue resection (Procedure)
结局指标
主要结局
Clinical Success of Endoscopic Procedure
时间窗: 6 months
Technical success and the avoidance of surgery for large non-pedunculated colorectal polyps (LNPCPs) referred for endoscopic resection, assessed at first surveillance colonoscopy. LNPCPs with features consistent with invasive disease and directly referred for surgery are excluded.
Technical Success of Endoscopic Procedure
时间窗: Intra-procedure
Complete removal of all visible polypoid tissue during index procedure.
次要结局
- Peri-Procedural Adverse Outcomes(6 months)
研究者
Neal Shahidi
Assistant Professor of Medicine
University of British Columbia
