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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05402696
Other study ID # H22-00037
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 27, 2022
Est. completion date December 31, 2032

Study information

Verified date November 2022
Source University of British Columbia
Contact Shirley X Jiang, MD
Phone (604) 688-6332
Email sjiangx@alumni.ubc.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 3500
Est. completion date December 31, 2032
Est. primary completion date December 31, 2032
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopic tissue resection
Endoscopic resection techniques for removal of large polyps

Locations

Country Name City State
Canada Mount Saint Joseph Hospital Vancouver British Columbia
Canada Pacific Gastroenterology Associates Vancouver British Columbia
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technical Success of Endoscopic Procedure Complete removal of all visible polypoid tissue during index procedure. Intra-procedure
Primary 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 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
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