Observational study on removing large colorectal polyps
Large Polyp Study (LPS) III - Endoscopic Resection of Large Colorectal Polyps: An Observational Cohort Study
This study is testing different ways to safely remove large polyps from the colon and duodenum to see how well they work for a wider range of patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | White River Junction Veterans Affairs Medical Center Federal |
| Locations | 1 site (White River Junction, Vermont) |
| Trial ID | NCT04220905 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the safety and effectiveness of endoscopic resection techniques for large colorectal and duodenal polyps. It builds on previous research primarily conducted in Australia, seeking to determine if those findings are applicable to a broader population. The study will enroll patients who may not qualify for randomized trials, allowing for a more representative sample and the exploration of various resection methods. By examining outcomes in a diverse patient population, the study aims to enhance understanding of adverse event risks associated with polyp removal.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older with large colorectal polyps (≥20mm) or duodenal polyps (≥10mm) who are undergoing endoscopy.
Not a fit: Patients requiring emergency endoscopy, those with significant coagulopathy, poor bowel preparation, or who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and efficacy of large polyp removal, potentially reducing the risk of colorectal and duodenal cancer.
How similar studies have performed: Previous studies have shown promising results in the safety and efficacy of large polyp resections, but this study aims to validate those findings in a different population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient ≥18 who presents for an upper endoscopy or colonoscopy and who does not have criteria for exclusion * Patients with a ≥20mm colon polyp * Patients with a ≥10mm duodenal polyp Exclusion Criteria: * Patients who are receiving an emergency endoscopy * Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50 * Poor bowel preparation * Pregnancy
Where this trial is running
White River Junction, Vermont
- White River Junction VAMC — White River Junction, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Heiko Pohl, MD — White River Junction Veterans Affairs Medical Center
- Study coordinator: Heiko Pohl, MD
- Email: heiko.pohl@va.gov
- Phone: 8022959363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.