- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04727918
Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal (BIOPANS)
January 27, 2021 updated by: Gabriel RAHMI
Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal: a Multicenter Randomized Controlled Trial
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France, 75015
- Hôpital Européen Georges Pompidou 20, rue Leblanc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Cold biopsy forceps (CBF)
Patients will be allocated to the CBF arm after randomization (1:1)
|
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).
|
ACTIVE_COMPARATOR: Cold snare polypectomy (CSP)
Patients will be allocated to the CSP arm after randomization (1:1)
|
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
|
What is the study measuring?
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.
Time Frame: through study completion, an average of 2 years.
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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)
Time Frame: through study completion, an average of 2 years.
|
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)
Time Frame: through study completion, an average of 2 years.
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measure of the time until complete polyp resection is obtained
|
through study completion, an average of 2 years.
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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
|
All patients will be followed-up until 28 days post-colonoscopy.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 5, 2017
Primary Completion (ACTUAL)
July 3, 2019
Study Completion (ACTUAL)
July 3, 2020
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
January 26, 2021
First Posted (ACTUAL)
January 27, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 1, 2021
Last Update Submitted That Met QC Criteria
January 27, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFED 105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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