Clinical trial NCT05293457: AI-assisted Gastroscopic Varicose Vein Diagnosis
Official title: A Prospective Multicenter Study of AI-assisted Gastroscopic Varices Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Artificial Intelligence
Keywords: artificial intelligence
Varicose veins
Cirrhosis
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 793
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cirrhosis who visited each center of the study from February 2022 to December 2022.

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

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.

Eligibility criteria: 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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Primary outcomes:
measure: The accuracy of artificial intelligence
timeFrame: 2022/12/25
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References: