Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
Completed · Not applicable
Conditions studied: Colon Polyps
In brief
The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.
Key facts
- Study ID
- NCT01936948
- Run by
- White River Junction Veterans Affairs Medical Center
- People needed
- 928
- Starts
- 2013-04-01
- Expected to finish
- 2022-10-01
- Last updated by the study team
- 2024-07-12
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion
- Patients with a ≥20mm non-pedunculated colon polyp
You may not qualify if…
- Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
- Patients with inflammatory bowel disease
- Patients who are receiving an emergency colonoscopy
- Poor general health (ASA class>3)
- Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
- Poor bowel preparation
- Pregnancy
Where it is running
- White River Junction VAMC — White River Junction, Vermont, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.