Colorectal Adenoma, Colorectal Lesions
Conditions
Keywords
Cold forceps polypectomy, Colonoscopy, Cold snare polypectomy
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.
Interventions
DEVICESampling 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.
Sponsors
Azienda USL Modena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Only the medical staff who will assess for possible complications, by calling patients 30 days post-polypectomy, will be blinded.
Intervention model description
Multicenter, Prospective, Randomized, Controlled Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incomplete resection rate | Immediately after the procedure and immediately after the histological evaluation of the biopsy samples | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to 30 days after the procedure | 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.) |
| Lesion retrieval rate | During the polypectomy | Lesion retrieval rate, in relation to the resection site |
| Polypectomy duration | During the polypectomy | 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 |
Countries
Italy
Contacts
Primary ContactNoemi Gualandi
Outcome results
None listed