An interventional study of Sampling from the resection margins in Colorectal Adenoma and Colorectal Lesions, sponsored by Azienda USL Modena. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Azienda USL Modena · Not applicable, Interventional, and Treatment
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".
Exclusion Criteria:
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)
Device: Sampling from the resection margins
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
Device: Sampling from the resection margins
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.
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
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
Lesion retrieval rate
Lesion retrieval rate, in relation to the resection site
Time frame: 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
Time frame: During the polypectomy
Plan to share: Undecided
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Azienda USL Modena