Colorectal PolypNCT04831814
Narrow Band Imaging in Diagnosis of Colorectal Polyps
A study testing Near Focus NBI and Standard Focus NBI in people with Colorectal Polyp and Colorectal Neoplasms, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Polyp, Colorectal Neoplasms
- What is being tested?
- Near Focus NBI and Standard Focus NBI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteThailand
- Study dates
- 4 Apr 2019to 14 Jan 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were scheduled for colonoscopy at NKC institute
Who cannot join
- Inflammatory bowel disease
- Polyposis syndrome
- Colorectal cancer
- Active gastrointestinal bleeding
- Pregnant woman
- Inadequate bowel preparation
- Contraindication for polyps removal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Near-focus Versus Normal-focus Narrow Band Imaging Colonoscopy in Diagnosis of Colorectal Polyps Based on Combined NICE and WASP Classification: a Randomized Controlled Trial
Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively.
Read the detailed description
Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard.
- Conditions
- Colorectal Polyp, Colorectal Neoplasms
- Being tested
- Near Focus NBI, Standard Focus NBI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Focus NBIDiagnostic test
Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively.
Standard Focus NBIDiagnostic test
Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Near Focus NBI | Experimental | Use of the Near Focus NBI to make optical diagnosis Receives: Diagnostic Test: Near Focus NBI |
| Standard Focus NBI | Active comparator | Use of the Standard Focus NBI to make optical diagnosis Receives: Diagnostic Test: Standard Focus NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of accurate polyp histology predictions by the Endoscopists in the two groups.
Measure of the percentage of accurate predictions by the endoscopists in the differentiation of neoplastic from non neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without near focus features
Measured: At the time of procedure
Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.
Measure of the percentage od accurate predictions by the endoscopists in the differentiation of sessile serrated polyps/adenoma from hyperplastic polyps, using the high definition NBI colonoscopy with and without near focus features.
Measured: At the time of procedure
Secondary outcomes (3)
The polyp detection rate
The prevalence of patients with at least one polyp was detected
Measured: At the time of procedure
The adenoma detection rate
The prevalence of patients with at least one adenoma was detected
Measured: At the time of procedure
Diagnostic Characteristics
Compare the diagnostic characteristic (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without near focus features.
Measured: At the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start4 Apr 2019
- Primary completion2 Jul 2020
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Netinatsunton, Prince of Songkla University
- Investigators
- NISA NETINATSUNTON, MD., Principal investigator, NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831814
- Sponsor's protocol ID
- 61355143
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-focus Versus Normal-focus Narrow Band Imaging Colonoscopy in Diagnosis of Colorectal Polyps Based on Combined NICE and WASP Classification: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04831814
- Acronym / sponsor ID
- 61355143
- Conditions
- Colorectal Polyp, Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 5 Apr 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.
Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were developed for diagnosis of adenomatous and sessile serrated polyps, respectively.
Detailed description
Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF and SF. There were few studies comparing diagnostic accuracy between NF and SF in the diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic polyp in sessile lesions using histologic evaluation as the gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Near Focus NBI | Experimental | Diagnostic Test: Near Focus NBIUse of the Near Focus NBI to make optical diagnosis |
| Standard Focus NBI | Active comparator | Diagnostic Test: Standard Focus NBIUse of the Standard Focus NBI to make optical diagnosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were scheduled for colonoscopy at NKC institute
Key exclusion criteria (7 listed)
- Inflammatory bowel disease
- Polyposis syndrome
- Colorectal cancer
- Active gastrointestinal bleeding
- Pregnant woman
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 |
|---|---|---|
| Near Focus NBIColonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively. | Diagnostic test | Near Focus NBI |
| Standard Focus NBIColonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively. | Diagnostic test | Standard Focus NBI |
Primary outcome
Rate of accurate polyp histology predictions by the Endoscopists in the two groups.
Time frame: At the time of procedure
Measure of the percentage of accurate predictions by the endoscopists in the differentiation of neoplastic from non neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without near focus features
Rate of accurate diagnosis of sessile serrated polyps/adenoma by the Endoscopists in the two groups.
Time frame: At the time of procedure
Measure of the percentage od accurate predictions by the endoscopists in the differentiation of sessile serrated polyps/adenoma from hyperplastic polyps, using the high definition NBI colonoscopy with and without near focus features.
3 secondary outcomes
The polyp detection rate
Time frame: At the time of procedure
The adenoma detection rate
Time frame: At the time of procedure
Diagnostic Characteristics
Time frame: At the time of procedure
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 12 May 2021.
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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.
NISA NETINATSUNTON, MD. principal investigator
NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near Focus NBI and Standard Focus NBI in people with Colorectal Polyp and Colorectal Neoplasms, run by Prince of Songkla University at 1 site in Thailand.
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 7 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 12 May 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 Thailand. 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?
Rate of accurate polyp histology predictions by the Endoscopists in the two groups. (time frame: At the time of procedure). The study lists 2 primary outcomes in all. 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 12 May 2021.