The St. Paul's Hospital Advanced Endoscopic Resection Centre Cohort for Colorectal Neoplasia (SPARC-C): A Prospective Observational Study
Summary
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.
Detailed description
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).
Arms & interventions
- ProcedureEndoscopic tissue resection
Endoscopic resection techniques for removal of large polyps
Outcome measures
Primary
Technical Success of Endoscopic Procedure
Complete removal of all visible polypoid tissue during index procedure.
Time frame: Intra-procedure
Clinical Success of Endoscopic Procedure
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.
Time frame: 6 months
Secondary
Peri-Procedural Adverse Outcomes
Time frame: 6 months
Eligibility criteria
Study locations (1)
St. Cloud Hospital
Saint Cloud, Minnesota, 56303