An interventional study of Cold Snare Polypectomy of intermediate sized polyps (10-15 mm) in Colorectal Polyp and Colorectal Adenoma, sponsored by Technical University of Munich. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-09.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Treatment
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 - 20 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 feasibility trial, the investigators try to find out if CSP with a new designed polypectomy snare is efficient and safe in terms of complete resection (R0), pathological evaluation and adverse events.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's planned enrollment of 35 is below the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare
Also known as: Olympus SnareMaster® Plus
Complete Resection Rate (R0-resection)
Complete resection rate of polyps resected by cold snare polypectomy
Time frame: 6 month
Required additional attempts for complete resection during surgery
Where there more than one attempts for complete resection of the polyp during surgery?
Time frame: during surgery
Incidence of immediate and delayed bleeding.
Immediate bleeding: Bleeding \>30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.
Time frame: 3 weeks
Technical Impossibility of CSP during surgery
Necessity of changing to HSP, if CSP is technically not possible
Time frame: during surgery
Plan to share: No
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Technical University of Munich