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

Sponsor
University of British Columbia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05402696
Collaborator
(none)
3,500
Enrollment
126
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic tissue resection

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The St. Paul's Hospital Advanced Endoscopic Resection Centre Cohort for Colorectal Neoplasia (SPARC-C): A Prospective Observational Study
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2032
Anticipated Study Completion Date :
Dec 31, 2032

Arms and Interventions

Arm Intervention/Treatment
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).

Procedure: Endoscopic tissue resection
Endoscopic resection techniques for removal of large polyps
Other Names:
  • Endoscopic mucosal resection
  • Endoscopic submucosal dissection
  • Colonoscopic polypectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Technical Success of Endoscopic Procedure [Intra-procedure]

      Complete removal of all visible polypoid tissue during index procedure.

    2. 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.

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of British Columbia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Neal Shahidi, Assistant Professor of Medicine, University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT05402696
    Other Study ID Numbers:
    • H22-00037
    First Posted:
    Jun 2, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Neal Shahidi, Assistant Professor of Medicine, University of British Columbia
    Colorectal neoplasia
    Advanced endoscopy
    Endoscopic resection
    Additional relevant MeSH terms:
    Adenoma
    Neoplasms

    Study Results

    No Results Posted as of Jun 3, 2022