Clinical trial NCT06970808: Cold Snare Versus Cold Forceps Polypectomy for Small Lesions
Official title: Cold SNAre Versus Cold forcePS Polypectomy for Small Colorectal Lesions (Cold-SNAPS): a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Adenoma
Colorectal Lesions
Keywords: Cold forceps polypectomy
Colonoscopy
Cold snare polypectomy
Lead sponsor: Azienda USL Modena
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, Prospective, Randomized, Controlled Study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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".

Eligibility criteria: 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

Primary outcomes:
measure: Incomplete resection rate
timeFrame: Immediately after the procedure and immediately after the histological evaluation of the biopsy samples
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 30 days after the procedure
measure: Lesion retrieval rate
timeFrame: During the polypectomy
measure: Polypectomy duration
timeFrame: During the polypectomy
Other outcomes:
Locations:
city: Carpi
country: Italy
facility: AUSL Modena
state: Modena
Study officials:
affiliation: AUSL Modena
name: Mauro Manno
role: PRINCIPAL_INVESTIGATOR
References: