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| Name | Class |
|---|---|
| CentraCare | OTHER |
| Hadassah Medical Organization | OTHER |
| Vancouver Coastal Health Research Institute | OTHER |
| Providence Healthcare |
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The SPARC-C study is a prospective, multi-institutional 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.
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 prospective, multicentre cohort study of consecutive patients referred to an interventional endoscopist with a tertiary referral practice in minimally invasive endoscopic resection techniques for the management of a LNPCP. This study will be based at St. Paul's Hospital (and its affiliated sites), Vancouver General Hospital, and collaborating 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic tissue resection | Procedure | Endoscopic resection techniques for removal of large polyps |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success of Endoscopic Procedure | Complete removal of all visible polypoid tissue during index procedure. | Intra-procedure |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirley X Jiang, MD | Contact | (604) 688-6332 | sjiangx@alumni.ubc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Cloud Hospital | Recruiting | Saint Cloud | Minnesota | 56303 | United States |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| OTHER |
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| Mount Saint Joseph Hospital | Active, not recruiting | Vancouver | British Columbia | V5T 3N4 | Canada |
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V6B2W6 | Canada |
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| St. Paul's Hospital | Recruiting | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| Pacific Gastroenterology Associates | Recruiting | Vancouver | British Columbia | V6Z 2K5 | Canada |
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| Hadassah Ein Kerem Hospital | Active, not recruiting | Jerusalem | Israel |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |