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Not yet recruiting NCT07362524

AI-Assisted Real-Time Endoscopic Characterization of Diminutive Colorectal Polyps in Non-Academic Hospitals

No phase Interventional Colorectal Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-Assisted Real-time Endoscopic Diagnosis System.
Who it may be relevant to
Registry conditions: Colorectal Polyps. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Artificial Intelligence-assisted Optical Diagnosis for the Resect-and-discard Strategy in Clinical Practice in Non-academic Hospitals: a Randomized Controlled Study

Overview

To validate the feasibility of promoting colorectal diminutive polyp "predict, resect, and discard" and "diagnose and leave" strategies for non-experts in general hospitals through CADx system.

Detailed description

This study will: (1) develop and refine a deep learning model for optical diagnosis of diminutive colorectal polyps-predicting histologic type and the presence of advanced adenoma components-based on multicenter endoscopic videos; (2) conduct a randomized controlled study recruiting endoscopists from different regions and experience levels nationwide to evaluate, with or without access to the model's diagnostic output, the success rates of implementing the "resect and discard" and "diagnose and leave" strategies as well as identifying advanced adenoma components; and (3) carry out a prospective randomized controlled trial to assess the benefits of a real-time AI-assisted endoscopic system in facilitating endoscopists' implementation of the "resect and discard" and "diagnose and leave" strategies for diminutive colorectal polyps.

Interventions

  • Device AI-Assisted Real-time Endoscopic Diagnosis System
    CADx assists endoscopists in diagnosing colorectal diminutive polyps (\<=5cm) during colonoscopy using narrow-band imaging (NBI). The system provides real-time prediction values of NICE classification for colorectal polyp. The intervention group receives AI-assisted diagnostic information displayed

Primary outcome measures

  • Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines [Time frame: 14 days]
  • Negative Predictive Value for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Confidence [Time frame: 14 days]
Secondary outcome measures (8)
  • Agreement between optical- and histology-based post-polypectomy surveillance intervals according to according to European Guidelines [Time frame: 14 days]
  • Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Asia-Pacific Guidelines [Time frame: 14 days]
  • Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Expert Consensus on Outpatient Management of Colorectal Polyps [Time frame: 14 days]
  • Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Diagnostic Confidence [Time frame: 30 days]
  • Diagnostic Accuracy, Sensitivity and Specificity for Diagnosing Neoplastic Lesions in Diminutive Polyps under High Diagnostic Confidence [Time frame: 14 days]
  • Diagnostic Accuracy of Endoscopists in Characterizing Colorectal Diminutive Polyps when assessed with High Diagnostic Confidence. [Time frame: 14 days]
  • Improvement in Endoscopists' Diagnostic Confidence with AI Assistance [Time frame: 14 days]
  • Improvement in Endoscopists' Diagnostic Accuracy in Characterizing Colorectal Diminutive Polyps with AI Assistance. [Time frame: 14 days]

Eligibility criteria

Inclusion criteria

  • Agree to participate in this prospective randomized controlled study;
  • Age ≥18 years for colonoscopy;
  • At least one colorectal diminutive polyp (size <=5mm) found during examination;

Exclusion criteria

  • Already participating in other clinical trials, having signed informed consent and being in the follow-up period of other clinical trials;
  • Already participating in drug clinical trials and being in the washout period of experimental or control drugs;
  • History of drug or alcohol abuse or psychological disorders in the past five years;
  • Pregnant or lactating patients;
  • Known polyposis syndromes;
  • Patients with gastrointestinal bleeding;
  • Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
  • Patients with contraindications to tissue biopsy;
  • Previous history of allergic reactions to bowel cleansing agent components;
  • Suffering from intestinal obstruction or perforation, toxic megacolon, heart failure (Grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, etc.;
  • Patient's bowel preparation BBPS score <6 for this colonoscopy;
  • Researchers consider the patient unsuitable for trial participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

China · 2 centers
  • Nantong First People's Hospital — Nantong
  • Wuxi Ninth People's Hospital — Wuxi

Identifiers

NCT: NCT07362524 · KY2024-080-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗