N/A
N=928
Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
Colon Polyps
Bottom Line
View on ClinicalTrials.gov: NCT01936948 ↗Enrolled (actual)
928
Serious AEs
7.2%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Delayed Bleeding Complications — 16; 33 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clip closure (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- White River Junction Veterans Affairs Medical Center
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Delayed Bleeding Complications |
16; 33 | — |
| SECONDARY The Overall Number of Complications |
22; 44 | — |
| SECONDARY Complete Study Polyp Resection Rate |
— | — |
| SECONDARY Polyp Recurrence Rate |
— | — |
| SECONDARY The Number of Complications Associated With Clip Use |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01936948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.