Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05402696
Status:
RECRUITING
Last Update Posted:
2022-11-09
First Post:
2022-05-28
Brief Title:
St Pauls Advanced Resection Center Cohort for Colorectal Neoplasia SPARC-C
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The St Pauls Hospital Advanced Endoscopic Resection Centre Cohort for Colorectal Neoplasia SPARC-C A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARC-C
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 techniquesstrategies have mitigated the risk of technical failure clinically significant post-resection bleeding CSPEB significant deep mural injury S-DMIperforation 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 Pauls 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
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 Pauls 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None