AI-assisted Gastroscopic Varicose Vein Diagnosis

A Prospective Multicenter Study of AI-assisted Gastroscopic Varices Diagnosis

Validation of the accuracy of AI in assisting gastroscopic varices diagnosis through a prospective multicenter study

Study Overview

• Status: Enrolling by invitation
• Conditions: Artificial Intelligence

Detailed Description

This study is a multi-center prospective study. Patients who meet the inclusion and exclusion criteria of the study will collect their basic information during outpatient and hospitalization. The designated doctor will introduce the significance of this study to the patients and sign the informed consent. After the endoscopy of the patient, the video of the operation under the endoscope was collected and saved, and the AI was imported to obtain its conclusions on the above characteristics, as well as stratification and treatment recommendations. Follow-up requirements for third-party physicians who meet the inclusion criteria, record their various diagnosis and treatment recommendations after watching the video (mainly in the form of a selection questionnaire to avoid subjective bias), and the content of the questionnaire includes the veins observed in the endoscopic operation video. Varicose related features (with or without red sign, bleeding sign, varicose vein shape, diameter, color, mucosal sign), and corresponding risk stratification and treatment recommendations are required. For videos with inconsistent conclusions between AI and physicians, physicians will be asked to watch these videos with AI prompts again to give their opinions, and there will be a two-week buffer period between the first time and the second viewing. The reference standard for diagnosis will be obtained by three endoscopists watching videos without AI prompts, and the conclusions drawn by the three experts will be used as the reference standard. When the three experts have inconsistent conclusions, the three experts will discuss A consensus shall prevail. If no consensus can be reached in the end, the video will be discarded.

Primary and secondary endpoints were obtained by comparing the accuracy of diagnosis made by physicians and AI. All data were analyzed by SPSS statistical software.

• Study Type: Observational
• Enrollment (Anticipated): 793

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cirrhosis who visited each center of the study from February 2022 to December 2022.

Description

Inclusion Criteria:

1. Male or female aged 18 years or above;
2. Gastroscopy and related examinations are required to further clarify the characteristics of digestive tract diseases;
3. Patients with liver cirrhosis who have signs or symptoms of portal hypertension and have clinical indications for endoscopic screening for varicose veins.
4. Able to read, understand and sign the informed consent;
5. The researcher believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.

Exclusion Criteria:

1) Pregnant or breastfeeding women; 2) Patients with a history of esophagogastric surgery; 3) Patients who have received interventional or endoscopic treatment in the past; 4) The patient has high-risk diseases or other special conditions that are not suitable for participating in clinical trials; 5) The patient is clearly diagnosed with esophageal or gastric diverticulum, polyps, cancer and other diseases that may affect the observation of varicose veins; 6) The patient's endoscopic video cannot reach a consensus diagnosis and treatment opinion after being watched by three experts.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of artificial intelligence	Accuracy of AI in the description and treatment recommendations of esophagogastric varices diagnosis and endoscopic findings (form, color, red sign, hemorrhagic sign, and mucosal findings).	2022/12/25

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 25, 2022
• Primary Completion (Anticipated): October 25, 2022
• Study Completion (Anticipated): December 25, 2022

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: artificial intelligence; Cirrhosis; Varicose veins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: WDRY2022-K014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No