Cold Snare Versus Cold Forceps Polypectomy for Small Lesions (Cold-SNAPS)

Azienda USL Modena

Status: Begins enrollment in 6 months

Conditions: Colorectal Lesions; Colorectal Adenoma

Treatments: Device: Sampling from the resection margins

Study type: Interventional

Funder types: Other

Identifiers

NCT06970808

04-2025

Details and patient eligibility

About

The goal of this clinical trial is to compare the efficacy and the safety of a new device for cold forceps polypectomy (CFP)- a special jumbo forceps- to cold snare polypectomy (CSP) for small colorectal lesions, without adding peri- or post-procedural risks to the patient.

The main questions it aims to answer are:

• Does the cold forceps guarantee a complete endoscopic resection rate?
• How many adverse events could the jumbo forceps reduce in comparison to CSP?
• Does the lesion retrieval rate increase?
• Does the polypectomy duration decrease? Participants will be randomized to one or to the other group when a polypoid or non-polypoid lesion is identified. If multiple polyps are found in the same patient, they will be removed using the same polypectomy technique.

If polypectomy cannot be performed using the indicated technique, a crossover will be done according to the best practice of care principles.

Full description

The study is a Multicenter, Prospective, Randomized, Controlled Study. It is designed as a non-inferiority trial to assess whether the efficacy in polypectomy of the new jumbo cold forceps is non-inferior to that of the cold snare.

The investigators hypothesize a less number of adverse events with CFP, an increased lesion retrieval rate and a less duration of the polypectomy procedure.

All patients will be contacted, 30 days post-polypectomy, by blinded medical staff assessing for possible complications.

All consecutive patients with polyp lesions can be enrolled, the participation is voluntary and randomization will be performed using the "minimization technique".

Enrollment: 312 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged ≥ 18 years;
• Ability to provide informed consent;
• Presence of at least one colorectal polypoid/non-polypoid lesion < 10 mm

Exclusion criteria

• Primary or secondary coagulopathy;
• Improper interruption of dual antiplatelet therapy and/or antiplatelet therapy with P2Y12 receptor antagonists (clopidogrel, prasugrel, ticagrelor) and/or anticoagulant therapy;
• Chronic inflammatory bowel diseases;
• Inpatients undergoing colonoscopy;
• Colonoscopy as part of regional colorectal cancer screening;
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 2 patient groups

Cold snare polypectomy group

Active Comparator group

Description:

For CSP, a 10 mm cold snare will be used (cold snare, Boston Scientific Corporation®, Marlborough, Massachusetts and cold snare, Meditalia S.A.S.®, Palermo, Italy); for CFP, a dedicated forceps will be used (Leviathan® cold forceps, 10 mm opening; Meditalia S.A.S., Palermo, Italy)

Treatment:

Device: Sampling from the resection margins

Cold forceps polypectomy group

Experimental group

Description:

For CFP, Leviathan® will be used (Meditalia S.A.S., Palermo, Italy). The opening jaw reaches a 10 mm diameter, and the central section of each jaw has an enlarged diameter up to 3.6 mm compared to the oval axis, enhancing its capacity

Treatment:

Device: Sampling from the resection margins