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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Polyp, Colorectal Adenoma

Intervention / Treatment
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* Device: Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Proof-Of-Concept
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cold 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Resection Rate (R0-resection) | Complete resection rate of polyps resected by cold snare polypectomy | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Required additional attempts for complete resection during surgery | Where there more than one attempts for complete resection of the polyp during surgery? | during surgery | 
| Incidence of immediate and delayed bleeding. | Immediate bleeding: Bleeding >30 seconds after snaring. Delayed bleeding: Bleeding during the next 3 weeks. | 3 weeks | 
| Technical Impossibility of CSP during surgery | Necessity of changing to HSP, if CSP is technically not possible | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coldsnare polypectomy, hotsnare polypectomy, intermediate sized polyps