Back to results

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

Primary Purpose

Colorectal Polyps

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Polypectomy of diminutive colorectal polyps will be performed by CBF

Polypectomy of diminutive colorectal polyps will be performed by CSP

About this trial

This is an interventional treatment trial for Colorectal Polyps focused on measuring Polypectomy, Cold biopsy forceps, Cold snare polypectomy, Diminutive colorectal polyp

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Européen Georges Pompidou 20, rue Leblanc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Cold biopsy forceps (CBF)

Cold snare polypectomy (CSP)

Arm Description

Patients will be allocated to the CBF arm after randomization (1:1)

Patients will be allocated to the CSP arm after randomization (1:1)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Specimen retrieval rate (% time of polypectomy)

specimen will be immediately suctioned into the operating channel.

Procedure time ( overall time between introduction and removal of colonoscope)

measure of the time until complete polyp resection is obtained

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

Full Information

NCT ID

NCT04727918

First Posted

January 25, 2021

Last Updated

January 27, 2021

Sponsor

Gabriel RAHMI

1. Study Identification

Unique Protocol Identification Number

NCT04727918

Brief Title

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

Acronym

BIOPANS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

October 5, 2017 (Actual)

Primary Completion Date

July 3, 2019 (Actual)

Study Completion Date

July 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gabriel RAHMI

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Polyps

Keywords

Polypectomy, Cold biopsy forceps, Cold snare polypectomy, Diminutive colorectal polyp

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cold biopsy forceps (CBF)

Arm Type

Active Comparator

Arm Description

Patients will be allocated to the CBF arm after randomization (1:1)

Arm Title

Cold snare polypectomy (CSP)

Arm Type

Active Comparator

Arm Description

Patients will be allocated to the CSP arm after randomization (1:1)

Intervention Type

Procedure

Intervention Name(s)

Polypectomy of diminutive colorectal polyps will be performed by CBF

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Polypectomy of diminutive colorectal polyps will be performed by CSP

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

Complete histological resection was defined as the absence of visualized residual polyp after saline irrigation as well as negative biopsies of the polypectomy site

Time Frame

through study completion, an average of 2 years.

Secondary Outcome Measure Information:

Title

Specimen retrieval rate (% time of polypectomy)

Description

specimen will be immediately suctioned into the operating channel.

Time Frame

through study completion, an average of 2 years.

Title

Procedure time ( overall time between introduction and removal of colonoscope)

Description

measure of the time until complete polyp resection is obtained

Time Frame

through study completion, an average of 2 years.

Title

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).

Description

perforation, gastrointestinal and bleeding

Time Frame

All patients will be followed-up until 28 days post-colonoscopy.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hôpital Européen Georges Pompidou 20, rue Leblanc

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

35038578

Citation

Perrod G, Perez-Cuadrado-Robles E, Coron E, Pioche M, Becq A, Etchepare N, Danan D, Musquer N, Dray X, Laquiere A, Jais B, Broudin C, Benosman H, Cellier C, Rahmi G. Comparison of cold biopsy forceps vs cold snare for diminutive colorectal polyp removal: A multicenter non-inferiority randomized controlled trial. Clin Res Hepatol Gastroenterol. 2022 Mar;46(3):101867. doi: 10.1016/j.clinre.2022.101867. Epub 2022 Jan 14.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs