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

NCT ID: NCT05402696

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-27

Study Completion Date

2032-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Colon Adenoma Colon Polyp Colon Lesion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Endoscopic tissue resection

Intervention Type PROCEDURE

Endoscopic resection techniques for removal of large polyps

Interventions

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Endoscopic tissue resection

Endoscopic resection techniques for removal of large polyps

Intervention Type PROCEDURE

Other Intervention Names

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Endoscopic mucosal resection Endoscopic submucosal dissection Colonoscopic polypectomy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Neal Shahidi

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mount Saint Joseph Hospital

Vancouver, British Columbia, Canada

Site Status ACTIVE_NOT_RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status ACTIVE_NOT_RECRUITING

Pacific Gastroenterology Associates

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Shirley X Jiang, MD

Role: CONTACT

(604) 688-6332

Facility Contacts

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Shirley X Jiang

Role: primary

(604) 688-6332

Cherry Galorport

Role: backup

(604) 688-6332

Other Identifiers

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H22-00037

Identifier Type: -

Identifier Source: org_study_id

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