NCT05402696

St. Paul's Advanced Resection Center Cohort for Colorectal Neoplasia (SPARC-C)

The St. Paul's Hospital Advanced Endoscopic Resection Centre Cohort for Colorectal Neoplasia (SPARC-C): A Prospective Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,500 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The SPARC-C study is a prospective, single-centre 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 single-centre cohort study of consecutive patients referred for the management of LNPCPs to one of two interventional endoscopists with a tertiary referral practice in minimally invasive endoscopic resection techniques. It is based at St. Paul's Hospital and its affiliated 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).

Conditions

• Colon Adenoma
• Colon Polyp
• Colon Lesion

Interventions

Type	Name	Description
PROCEDURE	Endoscopic tissue resection	Endoscopic resection techniques for removal of large polyps

Timeline

• Start date: 2022-06-27
• Primary completion: 2032-12-31
• Completion: 2032-12-31
• First posted: 2022-06-02
• Last updated: 2022-11-09

Locations

3 sites across 1 country: Canada