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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:
If polypectomy cannot be performed using the indicated technique, a crossover will be done according to the best practice of care principles.
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold snare polypectomy group | Active Comparator | 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) |
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| Cold forceps polypectomy group | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after the procedure and immediately after the histological evaluation of the biopsy samples |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noemi Gualandi | Contact | +39 059659500 | gualandinoemi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mauro Manno | AUSL Modena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUSL Modena | Carpi | Modena | 41012 | Italy |
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Multicenter, Prospective, Randomized, Controlled Study
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Only the medical staff who will assess for possible complications, by calling patients 30 days post-polypectomy, will be blinded.
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| Up to 30 days after the procedure |
| Lesion retrieval rate | Lesion retrieval rate, in relation to the resection site | During the polypectomy |
| 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 | During the polypectomy |