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

N/ANot Yet RecruitingNCT07362524

Shanghai Jiao Tong University School of Medicine363 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

363

Conditions

Colorectal Polyps

Interventions

AI-Assisted Real-time Endoscopic Diagnosis SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Agree to participate in this prospective randomized controlled study; 2. Age ≥18 years for colonoscopy; 3. At least one colorectal diminutive polyp (size \<=5mm) found during examination; Exclusion Criteria: 1. Already participating in other clinical trials, having signed informed consent and being in the follow-up period of other clinical trials; 2. Already participating in drug clinical trials and being in the washout period of experimental or control drugs; 3. History of drug or alcohol abuse or psychological disorders in the past five years; 4. Pregnant or lactating patients; 5. Known polyposis syndromes; 6. Patients with gastrointestinal bleeding; 7. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery; 8. Patients with contraindications to tissue biopsy; 9. Previous history of allergic reactions to bowel cleansing agent components; 10. Suffering from intestinal obstruction or perforation, toxic megacolon, heart failure (Grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, etc.; 11. Patient's bowel preparation BBPS score \<6 for this colonoscopy; 12. Researchers consider the patient unsuitable for trial participation.

Locations (2)

Nantong First People's Hospital

Nantong, Jiangsu, China

Wuxi Ninth People's Hospital

Wuxi, Jiangsu, China

Outcomes

Primary Outcomes

Agreement between optical- and histology-based post-polypectomy surveillance intervals according to United States Multi-Society Task Force (USMSTF) guidelines

The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the U.S. 2020 USMSTF consensus for post-polypectomy surveillance.

Time frame: 14 days

Negative Predictive Value for Diagnosing Neoplastic Lesions in Rectosigmoid Diminutive Polyps under High Confidence

Time frame: 14 days

Secondary Outcomes

Agreement between optical- and histology-based post-polypectomy surveillance intervals according to according to European Guidelines

The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the European ESGE 2020 consensus for post-polypectomy surveillance.

Time frame: 14 days

Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Asia-Pacific Guidelines

The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the Asia-Pacific APWG 2022 consensus for post-polypectomy surveillance.

Time frame: 14 days

Agreement between optical- and histology-based post-polypectomy surveillance intervals according to Expert Consensus on Outpatient Management of Colorectal Polyps

The concordance between the follow-up intervals determined by endoscopists (integrating polyp pathology under high diagnostic confidence and pathology results under low diagnostic confidence) and the follow-up intervals based solely on pathological results, as recommended by the Expert Consensus on Outpatient Management of Colorectal Polyps (2025, Chengdu).

Central Contacts

Xiaobo Li, PhD

CONTACT

86+13901631056 lxb_1969@163.com

Data from ClinicalTrials.gov

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