A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)
- Conditions
- Adenomatous Polyps
- Registration Number
- NCT04816292
- Lead Sponsor
- Technical University of Munich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 850
- Indication for colonoscopy
- at least 1 adenomatous polyp 10-15 mm
- provided written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Complete resection rate 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 Outcome Measures
Name Time Method Rate of immediate bleeding with necessity of haemostasis During procedure Immediate bleeding: Bleeding \>30 seconds after snaring.
En-bloc resection rate During procedure Number of additional resections (snare/forceps) needed.
Rate of impossible resection by CSP During procedure An impossible resection by CSP needs electrocautery for successful resection.
Time required for resection During procedure Time required for resection is the time between the insertion of the snare into working channel to the end of polyp resection. In the HSP group, it is defined as the start of submucosal injection until the end of polyp resection.
Rate of procedure-related adverse events. 6 months Delayed bleeding, defined as haemorrhage after colonoscopy with the necessity of endoscopic haemostasis.
Trial Locations
- Locations (1)
Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München
🇩🇪München, Bavaria, Germany