A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Adenomatous Polyps
- Sponsor
- Technical University of Munich
- Enrollment
- 850
- Locations
- 1
- Primary Endpoint
- Complete resection rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Colorectal cancer (CRC) has become the third most common malignant tumor and is the second leading cause of cancer related deaths worldwide. Adenomatous polyps of the colon are possible precursor lesions for CRC. Screening for CRC has been shown effective in preventing CRC and related deaths, especially colonoscopy and resection of adenomatous polyps. Currently, for intermediate sized polyps 5 - 19 mm hot snare polypectomy (HSP) with the use of electrocautery is conventionally used, causing relevant adverse events including haemorrhage and postpolypectomy coagulation syndrome, but is safe regarding complete resection of the polyp due to burning effect on residual tissue. On the other hand, cold snare polypectomy (CSP) has grown popularity. Absence of electrocautery makes it technically easier and most important reduces adverse events. CSP is recommended as the preferred technique for polyps <5 mm by the European Society of Gastrointestinal Endoscopy (ESGE) guidelines. In literature, there is one multicenter trial from Japan recommending CSP for polyps 4-9 mm (average polyp size 5,4 mm) and only a few case studies for polyps 10-15 mm with inconsistent results, especially regarding the complete resection and pathological evaluation of the specimen.
In this randomized controlled trial, the investigators want to compare the complete resection rates of small and intermediate sized colorectal polyps 10-15 mm with CSP and HSP.
Investigators
Veit Phillip
Departement for Interdisciplinary Endoscopy
Technical University of Munich
Eligibility Criteria
Inclusion Criteria
- •Indication for colonoscopy
- •at least 1 adenomatous polyp 10-15 mm
- •provided written informed consent
Exclusion Criteria
- •American Society of Anaesthesiologists class IV or higher
- •florid inflammatory bowel disease
- •emergency indication for colonoscopy
- •haemorrhagic diathesis
- •continued dual antiplatelet therapy
- •continued anticoagulant therapy
Outcomes
Primary Outcomes
Complete resection rate
Time Frame: 6 months
The histological complete resection rate, determined by pathologically negative margins of the specimen and no residual adenomatous material obtained from two/four biopsies of the resection site.
Secondary Outcomes
- Rate of immediate bleeding with necessity of haemostasis(During procedure)
- En-bloc resection rate(During procedure)
- Rate of impossible resection by CSP(During procedure)
- Time required for resection(During procedure)
- Rate of procedure-related adverse events.(6 months)