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Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm

Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm With a Newly Designed Polypectomy Snare - A Feasibility Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04464837
Acronym
COLDSNAP-1
Enrollment
35
Registered
2020-07-09
Start date
2020-07-01
Completion date
2021-06-01
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenoma, Colorectal Polyp

Keywords

coldsnare polypectomy, hotsnare polypectomy, intermediate sized polyps

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 - 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.

Interventions

DEVICECold Snare Polypectomy of intermediate sized polyps (10-15 mm)

If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Proof-Of-Concept

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* indication for colonoscopy * signed informed consent * at least one polyp of the size 10-15mm * American Society of Anesthesiologists-classification (ASA) I-III

Exclusion criteria

* American Society of Anesthesiologists-classification (ASA) IV-VI * Inflammatory bowel disease (IBD) * known/suspected invasive colorectal cancer * contraindications for polypectomy * emergency indication for colonoscopy

Design outcomes

Primary

MeasureTime frameDescription
Complete Resection Rate (R0-resection)6 monthComplete resection rate of polyps resected by cold snare polypectomy

Secondary

MeasureTime frameDescription
Required additional attempts for complete resection during surgeryduring surgeryWhere there more than one attempts for complete resection of the polyp during surgery?
Incidence of immediate and delayed bleeding.3 weeksImmediate bleeding: Bleeding \>30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks.
Technical Impossibility of CSP during surgeryduring surgeryNecessity of changing to HSP, if CSP is technically not possible

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026