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NCT Number: NCT05402696

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

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.

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Key information

Conditions

Colon Adenoma Colon Lesion Colon Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Saint Joseph Hospital, Vancouver, British Columbia, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic tissue resection

Procedure

Endoscopic resection techniques for removal of large polyps

Other names: Endoscopic mucosal resection, Endoscopic submucosal dissection, Colonoscopic polypectomy

Primary outcomes

  1. Technical Success of Endoscopic Procedure

    Time frame: Intra-procedure

    Complete removal of all visible polypoid tissue during index procedure.

  2. Clinical Success of Endoscopic Procedure

    Time frame: 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 outcomes

  1. Peri-Procedural Adverse Outcomes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shirley X Jiang, MD

CONTACT

[email protected]

(604) 688-6332

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • CentraCare
  • Hadassah Medical Organization
  • Providence Healthcare
  • Vancouver Coastal Health Research Institute

Registry information

Official study title

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

Acronym: SPARC-C

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jun 2, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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