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

Not Applicable

Completed

• Conditions: Colorectal Polyps
• Interventions: Procedure: Polypectomy of diminutive colorectal polyps will be performed by CBF; Procedure: Polypectomy of diminutive colorectal polyps will be performed by CSP

• Registration Number: NCT04727918
• Lead Sponsor: Gabriel RAHMI

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-05
• Primary Completion: 2019-07-03
• Study Completion: 2020-07-03
• Status Verified: 2021-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-27
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold biopsy forceps (CBF)	Polypectomy of diminutive colorectal polyps will be performed by CBF	Patients will be allocated to the CBF arm after randomization (1:1)
Cold snare polypectomy (CSP)	Polypectomy of diminutive colorectal polyps will be performed by CSP	Patients will be allocated to the CSP arm after randomization (1:1)

Primary Outcome Measures

Name	Time	Method
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.	through study completion, an average of 2 years.	Complete histological resection was defined as the absence of visualized residual polyp after saline irrigation as well as negative biopsies of the polypectomy site

Secondary Outcome Measures

Name	Time	Method
Procedure time ( overall time between introduction and removal of colonoscope)	through study completion, an average of 2 years.	measure of the time until complete polyp resection is obtained
Specimen retrieval rate (% time of polypectomy)	through study completion, an average of 2 years.	specimen will be immediately suctioned into the operating channel.
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).	All patients will be followed-up until 28 days post-colonoscopy.	perforation, gastrointestinal and bleeding

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou 20, rue Leblanc; 🇫🇷 Paris, France