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NCT05402696Recruiting

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

University of British Columbia

Start Date

6/27/2022

Completion Date

12/31/2032

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

PROCEDURE

Endoscopic tissue resection

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Conditions

Colon AdenomaColon PolypColon Lesion

Locations

St. Cloud Hospital

Saint Cloud, Minnesota 56303

United States

Mount Saint Joseph Hospital

Vancouver, British Columbia V5T 3N4

Canada

Vancouver General Hospital

Vancouver, British Columbia V6B2W6

Canada

St. Paul's Hospital

Vancouver, British Columbia V6Z 1Y6

Canada

Pacific Gastroenterology Associates

Vancouver, British Columbia V6Z 2K5

Canada

Hadassah Ein Kerem Hospital

Jerusalem,

Israel