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).
