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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05402696
Acronym
SPARC-C
Enrollment
3500
Registered
2022-06-02
Start date
2022-06-27
Completion date
2032-12-31
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Adenoma, Colon Lesion, Colon Polyp

Keywords

Colorectal neoplasia, Advanced endoscopy, Endoscopic resection

Brief 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).

Interventions

PROCEDUREEndoscopic tissue resection

Endoscopic resection techniques for removal of large polyps

Sponsors

University of British Columbia
Lead SponsorOTHER
CentraCare
CollaboratorOTHER
Hadassah Medical Organization
CollaboratorOTHER
Vancouver Coastal Health Research Institute
CollaboratorOTHER
Providence Healthcare
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Success of Endoscopic Procedure6 monthsTechnical 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 ProcedureIntra-procedureComplete removal of all visible polypoid tissue during index procedure.

Secondary

MeasureTime frameDescription
Peri-Procedural Adverse Outcomes6 monthsFrequency 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.

Countries

Canada, Israel, United States

Contacts

CONTACTShirley X Jiang, MD
sjiangx@alumni.ubc.ca(604) 688-6332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026