Research on Endoscopic Precision Biopsy. (REPB)

February 28, 2022 updated by: Beijing Tsinghua Chang Gung Hospital

Research on Endoscopic Precision Biopsy Guided by AI System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 102218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study has been reviewed by the hospital ethics committee. The enrolled subjects were found to have advanced colorectal adenomas during colonoscopy, and already had the pathological results of AI-assisted guided biopsy. The patients were hospitalized for complete resection with EMR and ESD and were willing to participate in this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The accuracy of expert with or with-out AI
Procedure: AI-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.
The accuracy non-expert with or with-out AI
Procedure: AI-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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The accuracy of AI
Time Frame: June 2023
Concordance rate between biopsy and postoperative pathology
June 2023
The accuracy of expert with or without AI
Time Frame: June 2023
Concordance rate between expert experience and postoperative pathology
June 2023
The accuracy of non-expert with or without AI
Time Frame: June 2023
Concordance rate between non-expert experience and postoperative pathology
June 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tsinghua Chang Gung Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ruigang Wang, Beijing Tsinghua Changgeng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12021C1011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

After completing the pre-experiment.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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