Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal

Study Overview
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Brief Summary
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European guidelines recommend the use of cold snare polypectomy (CSP) for removal of diminutive colorectal polyps (DCP)(5 mm or less). However, for DCP < 4 mm cold biopsy forceps (CBF) may be optional. Moreover, CBF remains the endoscopist's technique of choice for polyp resection and CSP is associated with a failure of specimen retrieval for histology in up to 6.8% of cases. In this study, the investigators aimed to compare the efficacy of CSP with CBF for removal of DCP in routine colonoscopy

Official Title
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Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal: a Multicenter Randomized Controlled Trial

Conditions
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Colorectal Polyps

Intervention / Treatment
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* Procedure: Polypectomy of diminutive colorectal polyps will be performed by CBF
* Procedure: Polypectomy of diminutive colorectal polyps will be performed by CSP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Routine colonoscopy Patient older than 18 years at least one polyp measuring ≤ 5 mm Exclusion Criteria: inflammatory bowel disease polyposis syndrome, pregnancy inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cold biopsy forceps (CBF)<br>Patients will be allocated to the CBF arm after randomization (1:1) | Procedure: Polypectomy of diminutive colorectal polyps will be performed by CBF<br>* All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CBF : The CBF will be performed using a standard biopsy forceps (Gluton Life ® Life Partners). Multiple biopsies bites were taken until complete resection (as many as needed).<br>|
| Active Comparator: Cold snare polypectomy (CSP)<br>Patients will be allocated to the CSP arm after randomization (1:1) | Procedure: Polypectomy of diminutive colorectal polyps will be performed by CSP<br>* All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CSP : The CSB procedure will be performed using a 9 mm cold snare (Exacto ® Life Partners). One to two mm of normal surrounding mucosa will be ensnared around the base of the polyp, followed by mechanical excision without electrocautery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to compare CBF and CSP in terms of efficacy. The primary end-point is the rate of histological complete resection by anatomopathological examination. | Complete histological resection was defined as the absence of visualized residual polyp after saline irrigation as well as negative biopsies of the polypectomy site | through study completion, an average of 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specimen retrieval rate (% time of polypectomy) | specimen will be immediately suctioned into the operating channel. | through study completion, an average of 2 years. | 
| Procedure time ( overall time between introduction and removal of colonoscope) | measure of the time until complete polyp resection is obtained | through study completion, an average of 2 years. | 
| Procedure related adverse events will be collected (adverse events : %, number of event for each groupe) during the procedure or during the follow up period (28 days). | perforation, gastrointestinal and bleeding | All patients will be followed-up until 28 days post-colonoscopy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polypectomy, Cold biopsy forceps, Cold snare polypectomy, Diminutive colorectal polyp