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Completed

NCT Number: NCT04727918

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

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

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Key information

Conditions

Colorectal Polyps

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Européen Georges Pompidou 20, rue Leblanc

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polypectomy of diminutive colorectal polyps will be performed by CBF

Procedure

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).

Polypectomy of diminutive colorectal polyps will be performed by CSP

Procedure

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 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.

    Time frame: 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 outcomes

  1. Specimen retrieval rate (% time of polypectomy)

    Time frame: through study completion, an average of 2 years.

    specimen will be immediately suctioned into the operating channel.

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

    Time frame: through study completion, an average of 2 years.

    measure of the time until complete polyp resection is obtained

  3. 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).

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

    perforation, gastrointestinal and bleeding

Sponsors and collaborators

Lead sponsor

Gabriel RAHMI

Other

Registry information

Official study title

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

Acronym: BIOPANS

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 27, 2021
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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