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

Recruiting

• Conditions: Colon Lesion; Colon Adenoma; Colon Polyp
• Interventions: Procedure: Endoscopic tissue resection

• Registration Number: NCT05402696
• Lead Sponsor: University of British Columbia

Brief 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).

Study Timeline

• Study First Submitted: 2022-05-28
• Study First Submitted QC: 2022-05-28
• Study First Posted: 2022-06-02
• Study Start: 2022-06-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-09
• Primary Completion: 2032-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

• Patients ≥ 18 years of age referred for the management of an LNPCP
• Able to provide informed consent.

Exclusion Criteria

• Unable to provide informed consent
• Pregnant or lactating women.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Large non-pedunculated colorectal polyp (LNPCP)	Endoscopic tissue resection	Patients referred to St. Paul's Hospital for endoscopic management of a large (≥20mm) non-pedunculated colorectal polyp (LNPCP).

Primary Outcome Measures

Name	Time	Method
Clinical Success of Endoscopic Procedure	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	Intra-procedure	Complete removal of all visible polypoid tissue during index procedure.

Secondary Outcome Measures

Name	Time	Method
Peri-Procedural Adverse Outcomes	6 months	Frequency and management of peri-procedural adverse outcomes including clinically significant intra-procedural bleeding, significant deep mural injury, clinically significant post-resection bleeding, delayed perforation, recurrence, and referral to surgery.

Trial Locations

Locations (3)

Pacific Gastroenterology Associates; 🇨🇦 Vancouver, British Columbia, Canada

Mount Saint Joseph Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada