Efficacy and Safety of Cold Snare Polypectomy (CSP) of Intermediate Sized Colorectal Polyps 10-15 mm (COLDSNAP-1)

Technical University of Munich

Status: Unknown

Conditions: Colorectal Adenoma; Colorectal Polyp

Treatments: Device: Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)

Study type: Interventional

Funder types: Other

Identifiers

NCT04464837

COLDSNAP-1

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)