St. Paul's Advanced Resection Center Cohort for Colorectal Neoplasia (SPARC-C)

NCT05402696 | Recruiting

• 1 other identifier: H22-00037
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 3

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.

Conditions

Colon Adenoma; Colon Polyp; Colon Lesion

Keywords

Colorectal neoplasia; Advanced endoscopy; Endoscopic resection

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Peri-Procedural Adverse Outcomes

  6 months

Study Arms (1)

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).

Procedure: Endoscopic tissue resection

Interventions

Endoscopic tissue resection PROCEDURE

Endoscopic resection techniques for removal of large polyps

Also known as: Endoscopic mucosal resection, Endoscopic submucosal dissection, Colonoscopic polypectomy

Large non-pedunculated colorectal polyp (LNPCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients ≥ 18 years of age referred for the management of an LNPCP
• Able to provide informed consent.

You may not qualify if:

• Unable to provide informed consent
• Pregnant or lactating women.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (3)

Mount Saint Joseph Hospital

Vancouver, British Columbia, V5T 3N4, Canada

ACTIVE NOT RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

ACTIVE NOT RECRUITING

Pacific Gastroenterology Associates

Vancouver, British Columbia, V6Z 2K5, Canada

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Shirley X Jiang, MD

CONTACT

(604) 688-6332; sjiangx@alumni.ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 28, 2022
• First Posted: June 2, 2022
• Study Start: June 27, 2022
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)