NCT04816292Recruiting
A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm)
A Comparison of the Resection Rate for Hot and Cold Snare Polypectomy of Colorectal Polyps (10-15 Mm) - a Randomized Controlled Trial (COLDSNAP-2)
Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 850 (estimated)
- First submitted
- 23 Mar 2021
- Start date
- 5 Nov 2024
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Technical University of Munich
- NCT number
- NCT04816292
What you commit to
- Study type: Interventional
- Planned participants: 850
- From 5 Nov 2024 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- continued dual antiplatelet therapy
- continued anticoagulant therapy
Other illness
- florid inflammatory bowel disease
Other
- American Society of Anaesthesiologists class IV or higher
- emergency indication for colonoscopy
- haemorrhagic diathesis
Who the study is looking for
- Indication for colonoscopy
- at least 1 adenomatous polyp 10-15 mm
- provided written informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technische Universität München Coordinator of this site? Confirm its status | München | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.