Clinical trial NCT05402696: St. Paul's Advanced Resection Center Cohort for Colorectal Neoplasia (SPARC-C)
Official title: The St. Paul's Hospital Advanced Endoscopic Resection Centre Cohort for Colorectal Neoplasia (SPARC-C): A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colon Adenoma
Colon Polyp
Colon Lesion
Keywords: Colorectal neoplasia
Advanced endoscopy
Endoscopic resection
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success of Endoscopic Procedure
timeFrame: Intra-procedure
measure: Clinical Success of Endoscopic Procedure
timeFrame: 6 months
Secondary outcomes:
measure: Peri-Procedural Adverse Outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Mount Saint Joseph Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Gastroenterology Associates
state: British Columbia
Study officials:
References: