NCT04727918

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

January 25, 2021

Last Update Submit

January 27, 2021

Conditions

Colorectal Polyps

Keywords

PolypectomyCold biopsy forcepsCold snare polypectomyDiminutive colorectal polyp

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Specimen retrieval rate (% time of polypectomy)

    through study completion, an average of 2 years.

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

    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).

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

Study Arms (2)

Cold biopsy forceps (CBF)

ACTIVE COMPARATOR

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

Procedure: Polypectomy of diminutive colorectal polyps will be performed by CBF

Cold snare polypectomy (CSP)

ACTIVE COMPARATOR

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

Procedure: Polypectomy of diminutive colorectal polyps will be performed by CSP

Interventions

Polypectomy of diminutive colorectal polyps will be performed by CBFPROCEDURE

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).

Cold biopsy forceps (CBF)
Polypectomy of diminutive colorectal polyps will be performed by CSPPROCEDURE

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

Cold snare polypectomy (CSP)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Routine colonoscopy
  • Patient older than 18 years
  • at least one polyp measuring ≤ 5 mm

You may not qualify if:

  • inflammatory bowel disease
  • polyposis syndrome, pregnancy
  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Européen Georges Pompidou 20, rue Leblanc

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 35038578DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investagator, Medical Doctor

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 27, 2021

Study Start

October 5, 2017

Primary Completion

July 3, 2019

Study Completion

July 3, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

FR(1)