Colorectal DysplasiaNCT05542030
CAD EYE Detection of Remaining Lesions After EMR
A study testing EMR with CAD-Eye™, EMR without CAD-Eye™ and Follow-up colonoscopy with CAD-Eye™ in people with Colorectal Dysplasia and Colorectal Neoplasms, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
In the last decade, many innovative systems have been developed to support and improve the diagnosis accuracy during endoscopic studies. CAD-Eye™ (Fujifilm, Tokyo, Japan) is a computer-assisted diagnostic (CADx) system that uses artificial intelligence for the detection and characterization of polyps during… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Dysplasia, Colorectal Neoplasms
- What is being tested?
- EMR with CAD-Eye™, EMR without CAD-Eye™ and Follow-up colonoscopy with CAD-Eye™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEcuador
- Study dates
- 12 Sep 2022to 12 Sep 2024
- 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
- Patients referred to our center with an indication of colonoscopy and EMR for the treatment of lesions suspicious of high-grade dysplasia and early invasive cancer.
- Patients who authorize EMR and colonoscopy.
- Signed informed consent
Who cannot join
- Any clinical condition which makes EMR inviable.
- Poor bowel preparation score defined as the total Boston bowel preparation score (BBPS) <6 and the right-segment score <2
- Patients with more than one previous EMR
- Lost on a three-month follow-up after EMR
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Carlos Robles-Medranda
Guayaquil, Guayas, 090505
Carlos Robles-Medranda, MD FASGE, +59342109180, carlosoakm@yahoo.es
Hannah P. Lukashok, MD
About this study
Official title: Accuracy of CAD Eye in the Detection of Colonic Remaining Lesions After Endoscopic Mucosal Resection: a Pilot Study
In the last decade, many innovative systems have been developed to support and improve the diagnosis accuracy during endoscopic studies. CAD-Eye™ (Fujifilm, Tokyo, Japan) is a computer-assisted diagnostic (CADx) system that uses artificial intelligence for the detection and characterization of polyps during colonoscopy. However, the accuracy of CAD-Eye™ in the recognition of remaining lesions after endoscopic mucosal resection (EMR) has not been broadly evaluated.
Finally, based on the importance of complete resection of the colonic mucosal lesions, namely suspicious high-grade dysplasia or early invasive cancer, the investigators aimed to assess the accuracy of CAD-Eye™ in the detection of remaining lesions after the procedure.
Read the detailed description
Nowadays, the increased polyp and adenoma detection rate, and its early treatment have reduced considerably colorectal cancer-related mortality. For lesions suspicious of high-grade dysplasia or early invasive cancer, the endoscopic mucosal resection (EMR), along with snare polypectomy, is now considered one of the established standard treatments. However, there are many ´difficult-to-treat lesions´ such as the large and fibrotic ones, which can lead to incomplete resections.
Based on the above, many newly diagnostic techniques guided by artificial intelligence (AI), currently proposed to improve the polyp detection rate during colonoscopy, can be applied for the detection of remaining lesions after endoscopic treatment.
CAD-Eye™ is CADx for polyp detection and characterization. It improves polyp visualization by using techniques such as blue-laser imaging (BLI-LASER), blue-light imaging (BLI-LED), and linked-color imaging (LCI). This device aimed to improve real-time polyp detection, helping experts identify multiple polyps simultaneously and common inadvertently missed lesions (flat lesions, polyps in difficult areas).
CAD-Eye™ had demonstrated in previous studies an accuracy of 89% to 91.7% in polyp detection. However, few studies had demonstrated its performance in the detection of remaining lesions after EMR. The investigators aimed to take advantage of this system in the detection of remaining lesions immediately after EMR and in its endoscopic control after three months.
- Conditions
- Colorectal Dysplasia, Colorectal Neoplasms
- Being tested
- EMR with CAD-Eye™, EMR without CAD-Eye™, Follow-up colonoscopy with CAD-Eye™
- Keywords
- Artificial Intelligence, Colonoscopy, Endoscopic mucosal resection, Computer-assisted diagnosis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMR with CAD-Eye™Diagnostic test
Patients of group 1 undergoing Intervention 1 are subjected to an EMR with CAD-Eye™ to detect the remaining lesions immediately after the endoscopic procedure.
The suspected remaining lesions in the post-procedure defect detected with CAD-Eye™ are removed and sent to pathology to confirm the diagnosis.
EMR without CAD-Eye™Diagnostic test
Patients of group 2, undergoing intervention 2, subjected to an EMR alone. The immediate detection of remaining lesions is based on the visual impression of the expert.
The suspected remaining lesions in the post-procedure defect are removed and sent to pathology to confirm the diagnosis.
Follow-up colonoscopy with CAD-Eye™Diagnostic test
Patients undergoing Interventions 1 and 2, with a previous EMR, are assigned for a three-month follow-up using the CAD-Eye™ as a complementary procedure to detect remaining lesions.
For the detection of residual lesions, the colonoscope with the CAD-Eye™ assistance is used during the post-procedural scar evaluation. Suspicious lesions detected are removed and sent to pathology for final diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic mucosal resection + CAD-Eye™ | Experimental | This group constitutes patients with lesions suggestive of high-grade dysplasia or early invasive cancer approached with endoscopic mucosal resection, subjected to colonoscopy + CAD-Eye™ system evaluation for the detection of remaining malignant tissue.
For this group, the investigators used as a complement tool an AI system (CAD-Eye™) for the detection of remaining lesions immediately after EMR and in a three-month follow-up. Receives: Diagnostic Test: EMR with CAD-Eye™; Diagnostic Test: Follow-up colonoscopy with CAD-Eye™ |
| Endoscopic mucosal resection without CAD Eye | Active comparator | This group constitutes patients with lesions suggestive of high-grade dysplasia or early invasive cancer approached with endoscopic mucosal resection and subjected to colonoscopy. The detection of remaining lesions immediately after EMR is based on the visual impression of the expert.
For this group, the investigators used as a complement tool an AI system (CAD-Eye™) only for the evaluation of the post-procedure scar to detect remaining lesions in the three-month follow-up. Receives: Diagnostic Test: EMR without CAD-Eye™; Diagnostic Test: Follow-up colonoscopy with CAD-Eye™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesions recurrence after EMR
Detection of remaining lesions immediately after EMR procedure based on endoscopist expertise (EMR without CAD-Eye™ group) or CAD-Eye™ (EMR + CAD-Eye™ group). Lesions will be confirmed by biopsy.
Data will be summarized as frequencies.
Measured: up to 1 week
Lesions recurrence in a three-month follow-up after EMR
Evaluation of CAD-Eye™ in the detection of recurrent lesions after EMR procedure. Remaining lesions detected by CAD-Eye™ in the three-month follow-up. Lesions will be confirmed by biopsy.
Data will be summarized as frequencies.
Measured: up to 3 months
Secondary outcomes (1)
Recurrence risk after EMR
Calculate de recurrence risk by the Sydney EMR recurrence tool (SERT) in a scale from 0 to 4
- 2 points: size of 40 mm or larger
- 1 point: Intraprocedural bleeding (IPB)
- 1 point: high-grade dysplasia (HGD) in histopathology
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start12 Sep 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion12 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal DysplasiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded, single center, non-randomized prospective pilot study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas
- Investigators
- Carlos Robles-Medranda, MD FASGE, Principal investigator, Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542030
- Sponsor's protocol ID
- IECED-08202022
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kliegis L, Obst W, Bruns J, Weigt J. Can a Polyp Detection and Characterization System Predict Complete Resection? Dig Dis. 2022;40(1):115-118. doi: 10.1159/000516974. Epub 2021 May 6.
PubMed 33940578Yoshida N, Inoue K, Tomita Y, Kobayashi R, Hashimoto H, Sugino S, Hirose R, Dohi O, Yasuda H, Morinaga Y, Inada Y, Murakami T, Zhu X, Itoh Y. An analysis about the function of a new artificial intelligence, CAD EYE with the lesion recognition and diagnosis for colorectal polyps in clinical practice. Int J Colorectal Dis. 2021 Oct;36(10):2237-2245. doi: 10.1007/s00384-021-04006-5. Epub 2021 Aug 18.
PubMed 34406437Dumoulin FL, Hildenbrand R. Endoscopic resection techniques for colorectal neoplasia: Current developments. World J Gastroenterol. 2019 Jan 21;25(3):300-307. doi: 10.3748/wjg.v25.i3.300.
PubMed 30686899Neumann H, Kreft A, Sivanathan V, Rahman F, Galle PR. Evaluation of novel LCI CAD EYE system for real time detection of colon polyps. PLoS One. 2021 Aug 26;16(8):e0255955. doi: 10.1371/journal.pone.0255955. eCollection 2021.
PubMed 34437563Min M, Deng P, Zhang W, Sun X, Liu Y, Nong B. Comparison of linked color imaging and white-light colonoscopy for detection of colorectal polyps: a multicenter, randomized, crossover trial. Gastrointest Endosc. 2017 Oct;86(4):724-730. doi: 10.1016/j.gie.2017.02.035. Epub 2017 Mar 9.
PubMed 28286095Tate DJ, Desomer L, Klein A, Brown G, Hourigan LF, Lee EY, Moss A, Ormonde D, Raftopoulos S, Singh R, Williams SJ, Zanati S, Byth K, Bourke MJ. Adenoma recurrence after piecemeal colonic EMR is predictable: the Sydney EMR recurrence tool. Gastrointest Endosc. 2017 Mar;85(3):647-656.e6. doi: 10.1016/j.gie.2016.11.027. Epub 2016 Nov 28.
PubMed 27908600
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of CAD Eye in the Detection of Colonic Remaining Lesions After Endoscopic Mucosal Resection: a Pilot Study
- ClinicalTrials.gov ID
- NCT05542030
- Acronym / sponsor ID
- IECED-08202022
- Conditions
- Colorectal Dysplasia, Colorectal Neoplasms
- Keywords
- Artificial Intelligence, Colonoscopy, Endoscopic mucosal resection, Computer-assisted diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 12 Sep 2024 (estimated)
- First posted
- 15 Sep 2022 (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.
In the last decade, many innovative systems have been developed to support and improve the diagnosis accuracy during endoscopic studies. CAD-Eye™ (Fujifilm, Tokyo, Japan) is a computer-assisted diagnostic (CADx) system that uses artificial intelligence for the detection and characterization of polyps during colonoscopy. However, the accuracy of CAD-Eye™ in the recognition of remaining lesions after endoscopic mucosal resection (EMR) has not been broadly evaluated.
Finally, based on the importance of complete resection of the colonic mucosal lesions, namely suspicious high-grade dysplasia or early invasive cancer, the investigators aimed to assess the accuracy of CAD-Eye™ in the detection of remaining lesions after the procedure.
Detailed description
Nowadays, the increased polyp and adenoma detection rate, and its early treatment have reduced considerably colorectal cancer-related mortality. For lesions suspicious of high-grade dysplasia or early invasive cancer, the endoscopic mucosal resection (EMR), along with snare polypectomy, is now considered one of the established standard treatments. However, there are many ´difficult-to-treat lesions´ such as the large and fibrotic ones, which can lead to incomplete resections.
Based on the above, many newly diagnostic techniques guided by artificial intelligence (AI), currently proposed to improve the polyp detection rate during colonoscopy, can be applied for the detection of remaining lesions after endoscopic treatment.
CAD-Eye™ is CADx for polyp detection and characterization. It improves polyp visualization by using techniques such as blue-laser imaging (BLI-LASER), blue-light imaging (BLI-LED), and linked-color imaging (LCI). This device aimed to improve real-time polyp detection, helping experts identify multiple polyps simultaneously and common inadvertently missed lesions (flat lesions, polyps in difficult areas).
CAD-Eye™ had demonstrated in previous studies an accuracy of 89% to 91.7% in polyp detection. However, few studies had demonstrated its performance in the detection of remaining lesions after EMR. The investigators aimed to take advantage of this system in the detection of remaining lesions immediately after EMR and in its endoscopic control after three months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded, single center, non-randomized prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| Endoscopic mucosal resection + CAD-Eye™ | Experimental | Diagnostic Test: EMR with CAD-Eye™, Diagnostic Test: Follow-up colonoscopy with CAD-Eye™This group constitutes patients with lesions suggestive of high-grade dysplasia or early invasive cancer approached with endoscopic mucosal resection, subjected to colonoscopy + CAD-Eye™ system evaluation for the detection of remaining malignant tissue. For this group, the investigators used as a complement tool an AI system (CAD-Eye™) for the detection of remaining lesions immediately after EMR and in a three-month follow-up. |
| Endoscopic mucosal resection without CAD Eye | Active comparator | Diagnostic Test: EMR without CAD-Eye™, Diagnostic Test: Follow-up colonoscopy with CAD-Eye™This group constitutes patients with lesions suggestive of high-grade dysplasia or early invasive cancer approached with endoscopic mucosal resection and subjected to colonoscopy. The detection of remaining lesions immediately after EMR is based on the visual impression of the expert. For this group, the investigators used as a complement tool an AI system (CAD-Eye™) only for the evaluation of the post-procedure scar to detect remaining lesions in the three-month follow-up. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred to our center with an indication of colonoscopy and EMR for the treatment of lesions suspicious of high-grade dysplasia and early invasive cancer.
- Patients who authorize EMR and colonoscopy.
- Signed informed consent
Key exclusion criteria (5 listed)
- Any clinical condition which makes EMR inviable.
- Poor bowel preparation score defined as the total Boston bowel preparation score (BBPS) <6 and the right-segment score <2
- Patients with more than one previous EMR
- Lost on a three-month follow-up after EMR
- Pregnancy or nursing
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 |
|---|---|---|
| EMR with CAD-Eye™Patients of group 1 undergoing Intervention 1 are subjected to an EMR with CAD-Eye™ to detect the remaining lesions immediately after the endoscopic procedure. The suspected remaining lesions in the post-procedure defect detected with CAD-Eye™ are removed and sent to pathology to confirm the diagnosis. | Diagnostic test | Endoscopic mucosal resection + CAD-Eye™ |
| EMR without CAD-Eye™Patients of group 2, undergoing intervention 2, subjected to an EMR alone. The immediate detection of remaining lesions is based on the visual impression of the expert. The suspected remaining lesions in the post-procedure defect are removed and sent to pathology to confirm the diagnosis. | Diagnostic test | Endoscopic mucosal resection without CAD Eye |
| Follow-up colonoscopy with CAD-Eye™Patients undergoing Interventions 1 and 2, with a previous EMR, are assigned for a three-month follow-up using the CAD-Eye™ as a complementary procedure to detect remaining lesions. For the detection of residual lesions, the colonoscope with the CAD-Eye™ assistance is used during the post-procedural scar evaluation. Suspicious lesions detected are removed and sent to pathology for final diagnosis. | Diagnostic test | Endoscopic mucosal resection + CAD-Eye™, Endoscopic mucosal resection without CAD Eye |
Primary outcome
Lesions recurrence after EMR
Time frame: up to 1 week
Detection of remaining lesions immediately after EMR procedure based on endoscopist expertise (EMR without CAD-Eye™ group) or CAD-Eye™ (EMR + CAD-Eye™ group). Lesions will be confirmed by biopsy. Data will be summarized as frequencies.
Lesions recurrence in a three-month follow-up after EMR
Time frame: up to 3 months
Evaluation of CAD-Eye™ in the detection of recurrent lesions after EMR procedure. Remaining lesions detected by CAD-Eye™ in the three-month follow-up. Lesions will be confirmed by biopsy. Data will be summarized as frequencies.
1 secondary outcome
Recurrence risk after EMR
Time frame: up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 33940578Kliegis L, Obst W, Bruns J, Weigt J. Can a Polyp Detection and Characterization System Predict Complete Resection? Dig Dis. 2022;40(1):115-118. doi: 10.1159/000516974. Epub 2021 May 6.
- Background: PubMed 34406437Yoshida N, Inoue K, Tomita Y, Kobayashi R, Hashimoto H, Sugino S, Hirose R, Dohi O, Yasuda H, Morinaga Y, Inada Y, Murakami T, Zhu X, Itoh Y. An analysis about the function of a new artificial intelligence, CAD EYE with the lesion recognition and diagnosis for colorectal polyps in clinical practice. Int J Colorectal Dis. 2021 Oct;36(10):2237-2245. doi: 10.1007/s00384-021-04006-5. Epub 2021 Aug 18.
- Background: PubMed 30686899Dumoulin FL, Hildenbrand R. Endoscopic resection techniques for colorectal neoplasia: Current developments. World J Gastroenterol. 2019 Jan 21;25(3):300-307. doi: 10.3748/wjg.v25.i3.300.
- Background: PubMed 34437563Neumann H, Kreft A, Sivanathan V, Rahman F, Galle PR. Evaluation of novel LCI CAD EYE system for real time detection of colon polyps. PLoS One. 2021 Aug 26;16(8):e0255955. doi: 10.1371/journal.pone.0255955. eCollection 2021.
- Background: PubMed 28286095Min M, Deng P, Zhang W, Sun X, Liu Y, Nong B. Comparison of linked color imaging and white-light colonoscopy for detection of colorectal polyps: a multicenter, randomized, crossover trial. Gastrointest Endosc. 2017 Oct;86(4):724-730. doi: 10.1016/j.gie.2017.02.035. Epub 2017 Mar 9.
- Background: PubMed 27908600Tate DJ, Desomer L, Klein A, Brown G, Hourigan LF, Lee EY, Moss A, Ormonde D, Raftopoulos S, Singh R, Williams SJ, Zanati S, Byth K, Bourke MJ. Adenoma recurrence after piecemeal colonic EMR is predictable: the Sydney EMR recurrence tool. Gastrointest Endosc. 2017 Mar;85(3):647-656.e6. doi: 10.1016/j.gie.2016.11.027. Epub 2016 Nov 28.
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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.
Carlos Robles-Medranda, MD FASGE principal investigator
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMR with CAD-Eye™, EMR without CAD-Eye™ and Follow-up colonoscopy with CAD-Eye™ in people with Colorectal Dysplasia and Colorectal Neoplasms, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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 Ecuador. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Robles-Medranda, MD FASGE (+59342109180, carlosoakm@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesions recurrence after EMR (time frame: up to 1 week). 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?
On the ClinicalTrials.gov record for NCT05542030, which also lists 6 linked publications.
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 28 Sep 2023.