Endoscopic Tissue Resection for Colon Polyps

(SPARC-C Trial)

Recruiting at 2 trial locations

Overseen By Shirley X Jiang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Pregnancy, Lactation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best management strategies for large non-pedunculated colorectal polyps (LNPCPs), which are flat growths in the colon that can be difficult to remove. Researchers aim to gather detailed information on patients and their treatment outcomes using endoscopic tissue resection, a procedure that removes polyps with a special tube equipped with a camera. The study targets individuals referred to St. Paul's Hospital with polyps measuring 20mm or larger. Those dealing with this type of polyp and able to provide consent may be suitable candidates for the trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that endoscopic tissue resection is safe for managing large non-pedunculated colorectal polyps?

Research has shown that endoscopic tissue removal safely and effectively treats large, flat growths in the colon, known as LNPCPs. Studies indicate that this method poses fewer risks than surgery and is the preferred choice for removing these polyps. Patients who underwent this procedure experienced few negative side effects. Additionally, the chance of the polyps returning is low after treatment. This suggests that endoscopic tissue removal is well-tolerated and a reliable option for managing these types of polyps. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endoscopic tissue resection for large non-pedunculated colorectal polyps (LNPCP) because it offers a less invasive alternative to traditional surgical approaches. Unlike surgery, which often requires a hospital stay and longer recovery, endoscopic resection can be performed on an outpatient basis, allowing for quicker recovery times. This technique not only minimizes the risks associated with surgery, such as infection and longer healing, but also preserves more of the healthy surrounding tissue, which is particularly beneficial for large polyps. Additionally, it reduces the need for more extensive procedures, making it a promising option for patients with LNPCP.

What evidence suggests that endoscopic tissue resection is effective for managing large non-pedunculated colorectal polyps?

Research has shown that removing large colorectal polyps using an endoscope is safe and effective. These polyps are growths in the colon. Studies have found that this method is better than surgery because it is less invasive and carries fewer risks. One common technique, endoscopic mucosal resection (EMR), successfully removes these polyps with a high success rate and low risk of complications. Another method, endoscopic full-thickness resection (EFTR), effectively removes polyps in the rectum, often in one piece. Overall, these endoscopic methods provide a reliable way to treat large colorectal polyps with fewer problems than traditional surgery. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Able to provide informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Endoscopic Procedure

Participants undergo endoscopic resection techniques such as EMR, ESD, or CSR for the management of large non-pedunculated colorectal polyps

Intra-procedure

Peri-Procedural Monitoring

Monitoring and management of peri-procedural adverse outcomes including bleeding, injury, and recurrence

6 months

Follow-up

Participants are monitored for safety and effectiveness after the endoscopic procedure, including assessment at first surveillance colonoscopy

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Tissue Resection

How Is the Trial Designed?

Group I: Large non-pedunculated colorectal polyp (LNPCP) Experimental Treatment 1 Intervention

Patients referred to St. Paul's Hospital for endoscopic management of a large (≥20mm) non-pedunculated colorectal polyp (LNPCP).

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10417738/

Endoscopic Management of Large Non-Pedunculated ... Endoscopic resection (ER) of large non-pedunculated colorectal polyps ≥ 20 mm (LNPCPs) is safe, effective and the preferred treatment compared to surgery.

2. egastroenterology.bmj.com egastroenterology.bmj.com/content/2/2/e100025

Endoscopic resection of large non-pedunculated colorectal ... A recent study found that EFTR is the most effective for rectal lesions,103 with a higher en bloc resection rate (90%) and lower adverse events ...

3. gi.org gi.org/journals-publications/ebgi/lee_mar2024/

ESD vs EMR for Large Non-Pedunculated Colon Polyps EMR (either en bloc or piecemeal) is an efficient, safe, and effective approach to remove large, non-pedunculated colorectal polyps.

4. wjgnet.com wjgnet.com/1948-5190/full/v17/i7/107746.htm

Prevention and treatment of recurrence after endoscopic ... EMR is safe and cost-effective and offers a less invasive approach with a lower risk of procedure-related complications than surgical resection[ ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0016510725017225

Safety and efficacy of margin and base ablation after ... EMR is the mainstay of therapy for large colorectal polyps. A previous study has shown low adverse events and recurrence rates after EMR ...

6. giejournal.org giejournal.org/article/S0016-5107(24)03194-8/fulltext

Safety of first surveillance colonoscopy at 12 months after ... After piecemeal EMR (pEMR) of nonpedunculated colorectal lesions ≥20 mm, guidelines recommend first endoscopic surveillance at 6 months.