Skip to content

Research on Endoscopic Precision Biopsy.

Research on Endoscopic Precision Biopsy Guided by AI System

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05261932
Acronym
REPB
Enrollment
40
Registered
2022-03-02
Start date
2021-11-26
Completion date
2023-11-30
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenoma

Keywords

AI system, Colonoscope, Guided Biopsy

Brief summary

Colorectal adenoma is a common disease and frequently-occurring disease in gastroenterology. With the continuous progress of colonoscopy equipment and the gradual improvement of endoscopic accessories, especially the development of chromo-endoscopy and magnifying endoscopy. The observation of the surface structure and capillary morphology of colorectal adenomas can realize optical biopsy. Currently, most clinical endoscopic diagnosis of colorectal diseases is biopsy under colonoscopy, and further treatment options are determined based on the pathological results of the biopsy. The problem is that the pathological diagnosis of some preoperative biopsy is not completely consistent with the pathological diagnosis of postoperative large specimens. Previous studies have found that the pathological diagnosis accuracy rate of preoperative biopsy is only 66-75%, so there is a certain degree of subjectivity in relying solely on colonoscopy white light biopsy. Based on the previous work, the research team has initially established an intelligent recognition model for colorectal adenoma classification (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia), and formed a colorectal adenoma of a certain size with annotated endoscopic image data set. Using the YOLO-V4 algorithm, under the Darknet framework, to train an artificial intelligence (AI) system which specifically for adenoma recognition and diagnosis, its accuracy rate has reached more than 90%. This study intends to increase the sample size based on the previous work, and further improve the accuracy of the classification and diagnosis of the AI system, so as to guide the endoscopist to perform targeted biopsy and improve the accuracy of preoperative biopsy.

Interventions

PROCEDUREAI-assisted guided biopsy

The surface of the adenoma was classified and identified by the AI system, and different areas of the adenoma were marked by distribution to guide the endoscopist for biopsy to obtain the poorly differentiated portion of the lesion.

Sponsors

Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age between 30-75; * Those who have no mental abnormality and can conduct questionnaire surveys; * BBPS ≥ 6; * Colorectal advanced adenoma, and admitted for complete resection with EMR and ESD; * Provide the relevant information required by this study and sign the informed consent.

Exclusion criteria

* Those who cannot provide the relevant information required by this research; * Patients with inflammatory bowel disease; * Those with a history of liver cirrhosis, uncontrolled hypertension, history of myocardial infarction, cardiac insufficiency, renal insufficiency, respiratory failure, diabetic ketosis and electrolyte imbalance and other serious diseases; * Those who cannot stop antiplatelet drugs or anticoagulant drugs; * Those who have not completed full colonoscopy; * Pregnant women.

Design outcomes

Primary

MeasureTime frameDescription
The accuracy of AIJune 2023Concordance rate between biopsy and postoperative pathology
The accuracy of expert with or without AIJune 2023Concordance rate between expert experience and postoperative pathology
The accuracy of non-expert with or without AIJune 2023Concordance rate between non-expert experience and postoperative pathology

Countries

China

Contacts

Primary ContactRuigang Wang
wrga02147@btch.edu.cn
Backup ContactXuan Jiang
jxa01998@btch.edu.cn+86 (010)56119096

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026