Colonic NeoplasmsNCT05500248
Artificial Intelligence for Leaving in Situ Colorectal Polyps.
A study testing Leave In Situ and Standard in people with Colonic Neoplasms, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This two parallel-arms, randomized, multicenter trial is aimed at investigating safety and effectiveness of a Computer-Aided-Diagnosis (CADx)-assisted leave-in-situ strategy (Leave-In-Situ Arm) as opposed to a resect-all strategy (Standard Arm) as implemented by endoscopists in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Leave In Situ and Standard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 919 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 30 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All >18 years-old patients undergoing elective colonoscopy
Who cannot join
- patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).
- Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale <2 in any colonic segment).
- patients with previous colonic resection.
- patients on antithrombotic therapy, precluding polyp resection.
- patients who were not able or refused to give informed written consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Computer-aided Optical Diagnosis (CADx) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial.
This two parallel-arms, randomized, multicenter trial is aimed at investigating safety and effectiveness of a Computer-Aided-Diagnosis (CADx)-assisted leave-in-situ strategy (Leave-In-Situ Arm) as opposed to a resect-all strategy (Standard Arm) as implemented by endoscopists in a real-world setting.
With this study it will be possible to understand the impact of CADx in patient treatment and management both in terms of clinical outcome and costs.
Read the detailed description
Real-time diminutive (≤5 mm) colonic polyp characterization by virtual blue-light (i.e. Narrow Banding Imaging [NBI], Blue Light Imaging [BLI], etc.) has been identified as a key goal for novel endoscopic advanced imaging techniques. The real-time prediction of polyps histology, especially of those located in the rectosigmoid, is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of harboring advanced histology (0.3%) and a negligible risk of invasive carcinoma (0%-0.08%).
Thus, as recommended by current guidelines, an optical diagnosis would allow diminutive polyps to be resected and discarded without pathological assessment (i.e. resect-and-discard strategy) or left in place without resection in the case of diminutive rectosigmoid hyperplastic polyps (i.e. leave-in-situ strategy), with an enormous cost-saving potential. In addition, the current policy for managing such hyperplastic-appearing polyps is poorly defined and variable from endoscopist to endoscopist. For instance, the European Society of Gastrointestinal Endoscopy (ESGE) recommends to leave-in-situ only diminutive polyps characterized as hyperplastic with high-confidence. However, it is currently unknown how many endoscopists actually do switch to the blue-light advanced imaging (when available) that is required for a high-confident diagnosis when assessing ≤5 mm hyperplastic-appearing lesions. More importantly, the Leave-in-situ strategy, poorly defined in a pre-AI era, has never been clinically validated, leaving uncertainty on the estimate of the possible false negatives generated by an inaccurate diagnosis6.
The availability of Computer-Aided-Diagnosis (CADx) tools, which may help endoscopists distinguish neoplastic from non-neoplastic polyps making the characterization process quicker and more objective, would be highly desirable and captivating.
A new system for CADx during white light endoscopy has been developed and integrated alongside a previously available Computer-Aided-Detection (CADe) tool (GI-Genius, Medtronic), making real-time characterization straightforward after polyp detection, and has been recently validated in a real time clinical trial, showing how this system exceeds the American Society of Gastrointestinal Endoscopy (ASGE) Criteria for clinical application of cost saving strategies (i.e. leave in situ and resect and discard), and equals the performance of expert endoscopists in optical diagnosis. However, this was a first study, monocentric and without randomization, with a small, albeit adequately powered, sample size. The need for larger trials is thus urgent to speed up the possible implementation of CADx in clinical practice.
Aim of this study is to clinically validate the new CADx tool for the implementation of a leave-in-situ strategy in a multicenter, randomized controlled trial.
- Conditions
- Colonic Neoplasms
- Being tested
- Leave In Situ, Standard
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leave In SituBehavioural
Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.
This behaviour is recommended by guidelines if the endoscopist is expert in optical diagnosis. In this case the endoscopists will be experts and they will also be helped by the CADx system that has shown to exceed the thresholds requested for use in clinical practice in previous trials.
StandardBehavioural
All identified polyps will be removed and sent to pathology.
| Study group | Role | What they receive |
|---|---|---|
| Leave-In-Situ Arm | Experimental | standard, high-definition colonoscopy with the use of Medtronic GI Genius module including both CADe and CADx. Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology. Receives: Behavioral: Leave In Situ |
| Standard arm | Active comparator | standard, high-definition colonoscopy with the use of Medtronic GI Genius module including both CADe and CADx. All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology. Receives: Behavioral: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
the proportion of participants with at least one adenoma (per-patient analysis) in the two arms
Measured: 1 year
Secondary outcomes (2)
Adenoma Detection Rate (ADR) in the rectosigmoid tract.
the proportion of participants with at least one adenoma (per-patient analysis) in the rectosigmoid tract in the two arms.
Measured: 1 year
Positive Predictive Value (PPV)
the proportion of clinically significant resected lesions among all resected lesions (per-polyp analysis) in the two arms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2023
- Study completion30 Aug 2024
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 NeoplasmsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 919 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Antonelli, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500248
- Sponsor's protocol ID
- PRACTICE
- Status last verified
- Oct 2024
- First submitted
- 11 Aug 2022
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Antonelli G, Desideri F, Scarozza P, Andrisani G, Zerboni G, Furnari M, Bevilacqua N, Cossignani M, Di Fonzo M, Cereatti F, Navazzotti G, Antenucci C, Di Matteo FM, Bevivino G, Caruso A, Spadaccini M, Schiavone S, Grossi C, Rizkala T, Comberlato M, Bretthauer M, Sharma P, Von Renteln D, Rex DK, Correale L, Repici A, Mori Y, Iacopini F, Hassan C. Safety of artificial intelligence-assisted optical diagnosis for leaving colorectal polyps in situ during colonoscopy (PRACTICE): a non-inferiority, randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):915-923. doi: 10.1016/S2468-1253(25)00140-2.
PubMed 40914178
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Computer-aided Optical Diagnosis (CADx) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial.
- ClinicalTrials.gov ID
- NCT05500248
- Acronym / sponsor ID
- PRACTICE
- Conditions
- Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 919 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 15 Aug 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.
This two parallel-arms, randomized, multicenter trial is aimed at investigating safety and effectiveness of a Computer-Aided-Diagnosis (CADx)-assisted leave-in-situ strategy (Leave-In-Situ Arm) as opposed to a resect-all strategy (Standard Arm) as implemented by endoscopists in a real-world setting.
With this study it will be possible to understand the impact of CADx in patient treatment and management both in terms of clinical outcome and costs.
Detailed description
Real-time diminutive (≤5 mm) colonic polyp characterization by virtual blue-light (i.e. Narrow Banding Imaging [NBI], Blue Light Imaging [BLI], etc.) has been identified as a key goal for novel endoscopic advanced imaging techniques. The real-time prediction of polyps histology, especially of those located in the rectosigmoid, is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of harboring advanced histology (0.3%) and a negligible risk of invasive carcinoma (0%-0.08%).
Thus, as recommended by current guidelines, an optical diagnosis would allow diminutive polyps to be resected and discarded without pathological assessment (i.e. resect-and-discard strategy) or left in place without resection in the case of diminutive rectosigmoid hyperplastic polyps (i.e. leave-in-situ strategy), with an enormous cost-saving potential. In addition, the current policy for managing such hyperplastic-appearing polyps is poorly defined and variable from endoscopist to endoscopist. For instance, the European Society of Gastrointestinal Endoscopy (ESGE) recommends to leave-in-situ only diminutive polyps characterized as hyperplastic with high-confidence. However, it is currently unknown how many endoscopists actually do switch to the blue-light advanced imaging (when available) that is required for a high-confident diagnosis when assessing ≤5 mm hyperplastic-appearing lesions. More importantly, the Leave-in-situ strategy, poorly defined in a pre-AI era, has never been clinically validated, leaving uncertainty on the estimate of the possible false negatives generated by an inaccurate diagnosis6.
The availability of Computer-Aided-Diagnosis (CADx) tools, which may help endoscopists distinguish neoplastic from non-neoplastic polyps making the characterization process quicker and more objective, would be highly desirable and captivating.
A new system for CADx during white light endoscopy has been developed and integrated alongside a previously available Computer-Aided-Detection (CADe) tool (GI-Genius, Medtronic), making real-time characterization straightforward after polyp detection, and has been recently validated in a real time clinical trial, showing how this system exceeds the American Society of Gastrointestinal Endoscopy (ASGE) Criteria for clinical application of cost saving strategies (i.e. leave in situ and resect and discard), and equals the performance of expert endoscopists in optical diagnosis. However, this was a first study, monocentric and without randomization, with a small, albeit adequately powered, sample size. The need for larger trials is thus urgent to speed up the possible implementation of CADx in clinical practice.
Aim of this study is to clinically validate the new CADx tool for the implementation of a leave-in-situ strategy in a multicenter, randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leave-In-Situ Arm | Experimental | Behavioral: Leave In Situstandard, high-definition colonoscopy with the use of Medtronic GI Genius module including both CADe and CADx. Polyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology. |
| Standard arm | Active comparator | Behavioral: Standardstandard, high-definition colonoscopy with the use of Medtronic GI Genius module including both CADe and CADx. All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All >18 years-old patients undergoing elective colonoscopy
Key exclusion criteria (6 listed)
- patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).
- Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
- patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale <2 in any colonic segment).
- patients with previous colonic resection.
- patients on antithrombotic therapy, precluding polyp resection.
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 |
|---|---|---|
| Leave In SituPolyps will be left in situ if diminutive (≤5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology. This behaviour is recommended by guidelines if the endoscopist is expert in optical diagnosis. In this case the endoscopists will be experts and they will also be helped by the CADx system that has shown to exceed the thresholds requested for use in clinical practice in previous trials. | Behavioural | Leave-In-Situ Arm |
| StandardAll identified polyps will be removed and sent to pathology. | Behavioural | Standard arm |
Primary outcome
Adenoma Detection Rate (ADR)
Time frame: 1 year
the proportion of participants with at least one adenoma (per-patient analysis) in the two arms
2 secondary outcomes
Adenoma Detection Rate (ADR) in the rectosigmoid tract.
Time frame: 1 year
Positive Predictive Value (PPV)
Time frame: 1 year
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 18 Apr 2025.
- Derived from this study: PubMed 40914178Antonelli G, Desideri F, Scarozza P, Andrisani G, Zerboni G, Furnari M, Bevilacqua N, Cossignani M, Di Fonzo M, Cereatti F, Navazzotti G, Antenucci C, Di Matteo FM, Bevivino G, Caruso A, Spadaccini M, Schiavone S, Grossi C, Rizkala T, Comberlato M, Bretthauer M, Sharma P, Von Renteln D, Rex DK, Correale L, Repici A, Mori Y, Iacopini F, Hassan C. Safety of artificial intelligence-assisted optical diagnosis for leaving colorectal polyps in situ during colonoscopy (PRACTICE): a non-inferiority, randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):915-923. doi: 10.1016/S2468-1253(25)00140-2.
- Individual participant dataSharing planned: Undecided
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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 Leave In Situ and Standard in people with Colonic Neoplasms, run by University of Roma La Sapienza 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 6 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 18 Apr 2025. 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?
Adenoma Detection Rate (ADR) (time frame: 1 year). 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 NCT05500248, 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 18 Apr 2025.