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Cold Snare Versus Cold Forceps Polypectomy for Small Lesions

ConditionsColorectal AdenomaColorectal Lesions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda USL Modena

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged ≥ 18 years;

Ability to provide informed consent;

Presence of at least one colorectal polypoid/non-polypoid lesion < 10 mm

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sampling from the resection margins

    Device

    After polypectomy, the base will be irrigated and assessed by the endoscopist, who may also use virtual or vital chromoendoscopy, if needed. Any residual adenomatous tissue will be removed using the same technique. To confirm the completeness of each polypectomy, two biopsies will be taken from the resection margins for polyps ≤ 5 mm, and three biopsies for polyps 6-9 mm, using standard biopsy forces.

Treatment groups

312 Participants
are divided into 2 treatment groups
Group A: Cold snare polypectomy groupActive comparator 1 intervention
Group B: Cold forceps polypectomy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incomplete resection rate

Compare the rate of incomplete endoscopic resection (IER) of CFP and CSP, defined as the presence of residual adenomatous tissue in the biopsy samples of the margins or after the visual assessment of the resection base.

Time frame
Immediately after the procedure and immediately after the histological evaluation of the biopsy samples

Secondary outcomes

1

Adverse events

Intraprocedural bleeding (i.e., post-polypectomy "spurting" or "oozing" bleeding lasting more than one minute of observation, requiring hemostatic interventions) and delayed bleeding (within 30 days of the procedure, requiring a second endoscopic treatment and/or hospitalization); perforation (intraprocedural or delayed), defined as grade III (damage to the muscular layer with recognition of the "target sign") or grade IV/V (full-thickness perforation of the bowel wall with or without contamination, respectively) according to the Sydney Classification. All patients will be contacted, 30 days post-polypectomy, by blinded medical staff assessing for possible complications (rectal bleeding, abdominal pain, hospitalization due to perforation/bleeding, etc.)

Time frame
Up to 30 days after the procedure
2

Lesion retrieval rate

Lesion retrieval rate, in relation to the resection site

Time frame
During the polypectomy
3

Polypectomy duration

Polypectomy duration evaluated in seconds: the time will be calculated from the exit of the device from endoscopic channel to the lesion retrieval. Cold forceps polypectomy is assumed to have a shorter procedural time, reducing the overall colonoscopy duration, improving patient compliance, and reducing the sedation required, with fewer risks related to sedation

Time frame
During the polypectomy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda USL Modena

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: