PolypectomyNCT02641509
Accuracy in Resection of Non-pedunculated Colonic Lesions 5-20 mm With/Without Using NBI
A study testing NBI during polypectomy and no NBI during polypectomy in people with Polypectomy, run by Valduce Hospital at 1 site in Italy.
Trial summary
Interval colon cancers are an important clinical issue. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypectomy
- What is being tested?
- NBI during polypectomy and no NBI during polypectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Every polyp ≥ 5 mm and ≤ 20 mm
Who cannot join
- Inflammatory bowel Disease and/or International Normalized Ratio > 1.5
Trial locations and contacts
1 site in 1 country.
About this study
Interval colon cancers are an important clinical issue. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology. In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.
Read the detailed description
Interval colon cancers are an important clinical issue. Literature dealing with technics and quality of polypectomy is scarce. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy and factors related to it, revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology (the majority of non completely resected ones, were polyps of 10-20 mm and with serrated characteristics at the histology). In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.
- Conditions
- Polypectomy
- Being tested
- NBI during polypectomy, no NBI during polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI during polypectomyDevice
NBI to perform the polipectomy
no NBI during polypectomyDevice
no NBI to perform the polypectomy
| Study group | Role | What they receive |
|---|---|---|
| NBI to perform the polipectomy | Experimental | this arm will undergo polypectomy with the use of NBI to define the margins of the lesion Receives: Device: NBI during polypectomy |
| no NBI to perform the polypectomy | Experimental | this arm will undergo polipectomy without the use of NBI to define the margins of the lesion Receives: Device: no NBI during polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolypectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alida Andrealli, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641509
- Sponsor's protocol ID
- 854/2015
- Status last verified
- May 2020
- First submitted
- 30 Nov 2015
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy in Resection of Non-pedunculated Colonic Lesions 5-20 mm With/Without Using NBI
- ClinicalTrials.gov ID
- NCT02641509
- Acronym / sponsor ID
- 854/2015
- Conditions
- Polypectomy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 29 Dec 2015 (estimated)
- 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.
Interval colon cancers are an important clinical issue. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology. In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.
Detailed description
Interval colon cancers are an important clinical issue. Literature dealing with technics and quality of polypectomy is scarce. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy and factors related to it, revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology (the majority of non completely resected ones, were polyps of 10-20 mm and with serrated characteristics at the histology). In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBI to perform the polipectomy | Experimental | Device: NBI during polypectomythis arm will undergo polypectomy with the use of NBI to define the margins of the lesion |
| no NBI to perform the polypectomy | Experimental | Device: no NBI during polypectomythis arm will undergo polipectomy without the use of NBI to define the margins of the lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Every polyp ≥ 5 mm and ≤ 20 mm
Key exclusion criteria (1 listed)
- Inflammatory bowel Disease and/or International Normalized Ratio > 1.5
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 |
|---|---|---|
| NBI during polypectomyNBI to perform the polipectomy | Device | NBI to perform the polipectomy |
| no NBI during polypectomyno NBI to perform the polypectomy | Device | no NBI to perform the polypectomy |
Primary outcome
NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
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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 NBI during polypectomy and no NBI during polypectomy in people with Polypectomy, run by Valduce Hospital at 1 site in Italy.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 May 2020. 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 Italy. 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 was stopped early. Results are not available in the source record.
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?
NBI efficacy in predicting radicality of polypectomy by taking random biopsies of margins after resection of the lesion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2020.