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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colon Adenoma; Colon Polyp; Colon Lesion
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 3500

Contacts and Locations

• Study Contact: Name: Shirley X Jiang, MD; Phone Number: (604) 688-6332; Email: sjiangx@alumni.ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5T 3N4
      • Active, not recruiting
      • Mount Saint Joseph Hospital
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Active, not recruiting
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • Recruiting
      • Pacific Gastroenterology Associates
      • Contact: Shirley X Jiang; Phone Number: (604) 688-6332; Email: sjiangx@alumni.ubc.ca
      • Contact: Cherry Galorport; Phone Number: (604) 688-6332; Email: CGalorport@providencehealth.bc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥18 years of age who have been referred to St. Paul's Hospital from 2022 to 2032 for management of a large (≥20mm) non-pedunculated colorectal polyp (LNPCP).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success of Endoscopic Procedure	Complete removal of all visible polypoid tissue during index procedure.	Intra-procedure
Clinical Success of Endoscopic Procedure	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-Procedural Adverse Outcomes	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.	6 months

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Anticipated): December 31, 2032
• Study Completion (Anticipated): December 31, 2032

Study Registration Dates

• First Submitted: May 28, 2022
• First Submitted That Met QC Criteria: May 28, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Endoscopic resection; Colorectal neoplasia; Advanced endoscopy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms; Adenoma
• Other Study ID Numbers: H22-00037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No