Colorectal PolypsBIOPANSNCT04727918
Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal
A study testing Polypectomy of diminutive colorectal polyps will be performed by CBF and Polypectomy of diminutive colorectal polyps will be performed by CSP in people with Colorectal Polyps, run by Gabriel RAHMI at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- Polypectomy of diminutive colorectal polyps will be performed by CBF and Polypectomy of diminutive colorectal polyps will be performed by CSP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2017to 3 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Routine colonoscopy
- Patient older than 18 years
- at least one polyp measuring ≤ 5 mm
Who cannot join
- inflammatory bowel disease
- polyposis syndrome, pregnancy
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Colorectal Polyps
- Being tested
- Polypectomy of diminutive colorectal polyps will be performed by CBF, Polypectomy of diminutive colorectal polyps will be performed by CSP
- Keywords
- Polypectomy, Cold biopsy forceps, Cold snare polypectomy, Diminutive colorectal polyp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypectomy of diminutive colorectal polyps will be performed by CBFProcedure or surgery
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 CSPProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Cold biopsy forceps (CBF) | Active comparator | Patients will be allocated to the CBF arm after randomization (1:1) Receives: 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) Receives: Procedure: Polypectomy of diminutive colorectal polyps will be performed by CSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 2 years.
Secondary outcomes (3)
Specimen retrieval rate (% time of polypectomy)
specimen will be immediately suctioned into the operating channel.
Measured: through study completion, an average of 2 years.
Procedure time ( overall time between introduction and removal of colonoscope)
measure of the time until complete polyp resection is obtained
Measured: 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).
perforation, gastrointestinal and bleeding
Measured: All patients will be followed-up until 28 days post-colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start5 Oct 2017
- Primary completion3 Jul 2019
- Study completion3 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabriel RAHMI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriel RAHMI, French Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727918
- Sponsor's protocol ID
- SFED 105
- Acronym
- BIOPANS
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35038578
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cold Biopsy Forceps vs Cold Snare for Diminutive Colorectal Polyp Removal: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04727918
- Acronym / sponsor ID
- BIOPANS / SFED 105
- Conditions
- Colorectal Polyps
- Keywords
- Polypectomy, Cold biopsy forceps, Cold snare polypectomy, Diminutive colorectal polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Gabriel RAHMIUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2020 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold biopsy forceps (CBF) | Active comparator | Procedure: Polypectomy of diminutive colorectal polyps will be performed by CBFPatients will be allocated to the CBF arm after randomization (1:1) |
| Cold snare polypectomy (CSP) | Active comparator | Procedure: Polypectomy of diminutive colorectal polyps will be performed by CSPPatients will be allocated to the CSP arm after randomization (1:1) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Routine colonoscopy
- Patient older than 18 years
- at least one polyp measuring ≤ 5 mm
Key exclusion criteria (3 listed)
- inflammatory bowel disease
- polyposis syndrome, pregnancy
- inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polypectomy of diminutive colorectal polyps will be performed by CBFAll 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). | Procedure or surgery | Cold biopsy forceps (CBF) |
| Polypectomy of diminutive colorectal polyps will be performed by CSPAll 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 | Procedure or surgery | Cold snare polypectomy (CSP) |
Primary outcome
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
3 secondary outcomes
Specimen retrieval rate (% time of polypectomy)
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Derived from this study: PubMed 35038578Perrod 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polypectomy of diminutive colorectal polyps will be performed by CBF and Polypectomy of diminutive colorectal polyps will be performed by CSP in people with Colorectal Polyps, run by Gabriel RAHMI at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.