Colonic PolypBIRDNCT03746171
Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps
An observational study of Colonic Polyp, run by Valduce Hospital at 1 site in Italy.
Trial summary
Several imaging technologies have been developed in order to enable the endoscopists to differentiate neoplastic from non-neoplastic lesions. The real-time prediction of polyps histology is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Colonic polyp characterization by BLI
- How many people
- 324 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 30 Oct 2019
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program or for CRC primary prevention, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected.
Who may be able to join
- Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program or for CRC primary prevention, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected.
Who cannot join
- patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
- patients with inadequate bowel preparation
- patients in which caecal intubation was not achieved or scheduled for partial examinations
- polyps could not be resected due to ongoing anticoagulation preventing resection and pathologic assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps: the BLI Resect and Discard (BIRD) Study.
Several imaging technologies have been developed in order to enable the endoscopists to differentiate neoplastic from non-neoplastic lesions. The real-time prediction of polyps histology is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of harboring advanced histology or invasive carcinoma. Thus, an optical diagnosis would allow diminutive polyps to be resected and discarded without pathological assessment or left in place without resection, with an enormous cost-saving potential. Recently, the American Society of Gastrointestinal Endoscopy (ASGE) has set the Preservation and Incorporation of Valuable endoscopic Innovation (PIVI) which defined accuracy threshold to be met, in order to consider a new technology ready to be incorporate into clinical practice. Blue Light Imaging (BLI) is a new chromoendoscopy technology integrated in the latest generation ELUXEOTM 7000 endoscopy platform (Fujifilm Co, Tokyo, Japan), based on the direct (i.e. not filtered) emission of blue light with short wavelength (410nm), that enhances visibility of both microvascular and superficial mucosal pattern. In a recent randomized trial BLI was superior to high-definition white light (HDWL) in the real time characterization of subcentimetric and diminutive colonic polyps. Nevertheless, in this study the paucity of diminutive rectosigmoid polyps analyzed does not allow to draw definite conclusions as the meeting of PIVI thresholds are concerned. Similarly, the low numbers of patients evaluated limited the per-patient analysis. Therefore further studies adequately powered to this clinically end-point were advocated. Additionally, when the study was performed a BLI dedicated classification for optical diagnosis of colonic polyps was not available, whereas recently a specific classification (the BLI Adenoma Serrated International Classification-BASIC) has been developed and a specific training set has been settled.
In the present study the investigators prospectively evaluate whether the use of BLI-assisted optical characterization of diminutive polyps using BASIC classification by specifically trained endoscopists may met PIVI thresholds and particularly if it allow the endoscopists to achieve > 90% correct assignment of post-polypectomy surveillance intervals when combined with the histopathology assessment of polyps >5 mm in size.
- Conditions
- Colonic Polyp
- Being tested
- Colonic polyp characterization by BLI
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic polyp characterization by BLIDiagnostic test
All rectosigmoid <5 mm polyps, regardless of the presence of larger polyps, will be characterized by BLI-assisted optical diagnosis by using BASIC criteria (neoplastic vs. non neoplastic) and will be included in polyp-level assessment.
The polyp characterization will be always performed and recorded without zoom magnification. In patients in which colonoscopy will be performed with endoscopes equipped with zoom magnification, the zoom will be eventually systematically applied and the characterization with zoom will be also recorded. The post-polypectomy surveillance intervals based on BLI will be calculated by using histology estimation performed without zoom for all patients. Only polyps characterized with high confidence will be included in the analysis; the high-confidence characterization rate will be calculated.
| Study group | Role | What they receive |
|---|---|---|
| Patients with rectosigmoid colonic polyps | Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected. Receives: Diagnostic Test: Colonic polyp characterization by BLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of post-polypectomy surveillance interval
Surveillance interval will be advised for each patient, basing on high-confidence predictions of <5mm polyp histology. Such information will be merged with the histopathology assessment of both polyps >5 mm in size and <5 mm lesions diagnosed with a low confidence. Patients with either only <5 mm lesions diagnosed with a low confidence or only >6 mm lesions will not be included. Endoscopy-directed surveillance strategy will be subsequently matched with histology-directed one for each patient and accordance rate will be calculated.
The post-polypectomy surveillance interval will be calculated in the frame of USMSTF guidelines.
Measured: 9 months
Secondary outcomes (2)
Accuracy parameters of BLI polyp characterization
Operative characteristics (sensitivity, specificity, positive and negative predictive value and accuracy) in distinguishing adenomatous from non-adenomatous polyps, evaluated with high confidence, will be calculated for each diminutive rectosigmoid polyp, having histopathology report as reference standard.
Measured: 9 months
Cost analysis
The cost (related to the polypectomy devices used and the histopathology assessment) will be calculated according to a BLI-directed policy and to a histology-directed policy per each patient included in the study. The cost saving will be eventually calculated.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Jan 2019
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
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 Colonic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Radaelli, Valduce Hospital
- Investigators
- Franco Radaelli, MD, Principal investigator, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746171
- Sponsor's protocol ID
- 229
- Acronym
- BIRD
- Status last verified
- May 2020
- First submitted
- 15 Nov 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rondonotti E, Hassan C, Andrealli A, Paggi S, Amato A, Scaramella L, Repici A, Radaelli F. Clinical Validation of BASIC Classification for the Resect and Discard Strategy for Diminutive Colorectal Polyps. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2357-2365.e4. doi: 10.1016/j.cgh.2019.12.028. Epub 2020 Jan 7.
PubMed 31923641
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps: the BLI Resect and Discard (BIRD) Study.
- ClinicalTrials.gov ID
- NCT03746171
- Acronym / sponsor ID
- BIRD / 229
- Conditions
- Colonic Polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 19 Nov 2018 (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.
Several imaging technologies have been developed in order to enable the endoscopists to differentiate neoplastic from non-neoplastic lesions. The real-time prediction of polyps histology is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of harboring advanced histology or invasive carcinoma. Thus, an optical diagnosis would allow diminutive polyps to be resected and discarded without pathological assessment or left in place without resection, with an enormous cost-saving potential. Recently, the American Society of Gastrointestinal Endoscopy (ASGE) has set the Preservation and Incorporation of Valuable endoscopic Innovation (PIVI) which defined accuracy threshold to be met, in order to consider a new technology ready to be incorporate into clinical practice. Blue Light Imaging (BLI) is a new chromoendoscopy technology integrated in the latest generation ELUXEOTM 7000 endoscopy platform (Fujifilm Co, Tokyo, Japan), based on the direct (i.e. not filtered) emission of blue light with short wavelength (410nm), that enhances visibility of both microvascular and superficial mucosal pattern. In a recent randomized trial BLI was superior to high-definition white light (HDWL) in the real time characterization of subcentimetric and diminutive colonic polyps. Nevertheless, in this study the paucity of diminutive rectosigmoid polyps analyzed does not allow to draw definite conclusions as the meeting of PIVI thresholds are concerned. Similarly, the low numbers of patients evaluated limited the per-patient analysis. Therefore further studies adequately powered to this clinically end-point were advocated. Additionally, when the study was performed a BLI dedicated classification for optical diagnosis of colonic polyps was not available, whereas recently a specific classification (the BLI Adenoma Serrated International Classification-BASIC) has been developed and a specific training set has been settled.
In the present study the investigators prospectively evaluate whether the use of BLI-assisted optical characterization of diminutive polyps using BASIC classification by specifically trained endoscopists may met PIVI thresholds and particularly if it allow the endoscopists to achieve > 90% correct assignment of post-polypectomy surveillance intervals when combined with the histopathology assessment of polyps >5 mm in size.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rectosigmoid colonic polyps | – | Diagnostic Test: Colonic polyp characterization by BLIConsecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program or for CRC primary prevention, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected.
Key inclusion criteria (1 listed)
- Consecutive adult (18-80 yrs) outpatients undergoing colonoscopy in the frame of the FOBT based screening program or for CRC primary prevention, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected.
Key exclusion criteria (4 listed)
- patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
- patients with inadequate bowel preparation
- patients in which caecal intubation was not achieved or scheduled for partial examinations
- polyps could not be resected due to ongoing anticoagulation preventing resection and pathologic assessment
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 |
|---|---|---|
| Colonic polyp characterization by BLIAll rectosigmoid <5 mm polyps, regardless of the presence of larger polyps, will be characterized by BLI-assisted optical diagnosis by using BASIC criteria (neoplastic vs. non neoplastic) and will be included in polyp-level assessment. The polyp characterization will be always performed and recorded without zoom magnification. In patients in which colonoscopy will be performed with endoscopes equipped with zoom magnification, the zoom will be eventually systematically applied and the characterization with zoom will be also recorded. The post-polypectomy surveillance intervals based on BLI will be calculated by using histology estimation performed without zoom for all patients. Only polyps characterized with high confidence will be included in the analysis; the high-confidence characterization rate will be calculated. | Diagnostic test | Patients with rectosigmoid colonic polyps |
Primary outcome
Accuracy of post-polypectomy surveillance interval
Time frame: 9 months
Surveillance interval will be advised for each patient, basing on high-confidence predictions of <5mm polyp histology. Such information will be merged with the histopathology assessment of both polyps >5 mm in size and <5 mm lesions diagnosed with a low confidence. Patients with either only <5 mm lesions diagnosed with a low confidence or only >6 mm lesions will not be included. Endoscopy-directed surveillance strategy will be subsequently matched with histology-directed one for each patient and accordance rate will be calculated. The post-polypectomy surveillance interval will be calculated in the frame of USMSTF guidelines.
2 secondary outcomes
Accuracy parameters of BLI polyp characterization
Time frame: 9 months
Cost analysis
Time frame: 9 months
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 19 May 2020.
- Derived from this study: PubMed 31923641Rondonotti E, Hassan C, Andrealli A, Paggi S, Amato A, Scaramella L, Repici A, Radaelli F. Clinical Validation of BASIC Classification for the Resect and Discard Strategy for Diminutive Colorectal Polyps. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2357-2365.e4. doi: 10.1016/j.cgh.2019.12.028. Epub 2020 Jan 7.
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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.
Franco Radaelli, MD principal investigator
Valduce Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyp, 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 4 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 19 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 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?
Accuracy of post-polypectomy surveillance interval (time frame: 9 months). 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 NCT03746171, 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 19 May 2020.