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Artificial Intelligence for Leaving in Situ Colorectal Polyps.

Primary Purpose

Colonic Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Leave In Situ
Standard
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

- All >18 years-old patients undergoing elective colonoscopy

Exclusion criteria:

  • 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.

Sites / Locations

  • Ospedale Dei CastelliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Leave-In-Situ Arm

Standard arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adenoma Detection Rate (ADR)
the proportion of participants with at least one adenoma (per-patient analysis) in the two arms
Positive Predictive Value (PPV)
the proportion of clinically significant resected lesions among all resected lesions (per-polyp analysis) in the two arms

Secondary Outcome Measures

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.

Full Information

First Posted
August 11, 2022
Last Updated
July 29, 2023
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT05500248
Brief Title
Artificial Intelligence for Leaving in Situ Colorectal Polyps.
Official Title
Impact of Computer-aided Optical Diagnosis (CADx) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Leave-In-Situ Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Leave In Situ
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard
Intervention Description
All identified polyps will be removed and sent to pathology.
Primary Outcome Measure Information:
Title
Adenoma Detection Rate (ADR)
Description
the proportion of participants with at least one adenoma (per-patient analysis) in the two arms
Time Frame
1 year
Title
Positive Predictive Value (PPV)
Description
the proportion of clinically significant resected lesions among all resected lesions (per-polyp analysis) in the two arms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adenoma Detection Rate (ADR) in the rectosigmoid tract.
Description
the proportion of participants with at least one adenoma (per-patient analysis) in the rectosigmoid tract in the two arms.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: - All >18 years-old patients undergoing elective colonoscopy Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulio Antonelli
Phone
0693278794
Email
giulio.antonelli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cesare Hassan, PRofessor
Phone
0693278544
Ext
0
Email
cesareh@hotmail.it
Facility Information:
Facility Name
Ospedale Dei Castelli
City
Ariccia
State/Province
Rome
ZIP/Postal Code
00040
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Antonelli, MD
Phone
+393391973276

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Artificial Intelligence for Leaving in Situ Colorectal Polyps.

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