Clinical trial NCT05435872: Gastrointestinal Endoscopy Artificial Intelligence Cloud Platform in Gastrointestinal Endoscopy Screening
Official title: Gastrointestinal Endoscopy Artificial Intelligence Cloud Platform in Gastrointestinal Endoscopy Screening: a Prospective Multi-center Real-world Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diagnoses Disease
Quality Control
Endoscopy
Artificial Intelligence
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Aerospace General Hospital
name: Beijing Fangshan District Liangxiang Hospital
name: People's Hospital of Beijing Daxing District
name: Gucheng County Hospital of Hebei Province
name: Nanhe County Hospital of Hebei Province
First posted: 2022-06-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Study objective: To establish a quality control system for gastrointestinal endoscopy based on artificial intelligence technology and an auxiliary diagnosis system that can perform lesion identification, improving the detection rate of early gastrointestinal cancer while standardizing, normalizing, and homogenizing the endoscopic treatment in primary hospitals (including some of the primary hospitals, which are participating in Beijing-Tianjin-Hebei Gastrointestinal Endoscopy Medical Consortium) under Gastrointestinal Endoscopy Artificial Intelligence Cloud Platform as the hardware base.

Study design: This study is a prospective, multi-center, real-world study.

Detailed description: This is a prospective, multi-center, real-world study. Before patients are formally enrolled, all endoscopic examination-related systems and endoscopists would be debugged and trained according to uniform standards and requirements, respectively. Patients who meet the inclusion criteria and do not meet the exclusion criteria are enrolled for this trial. All of them will be asked to sign an informed consent after fully understanding the facts about the research study, and will provide demographic information as well as some specific clinical data. Then, participants will be divided into the intervention group (Artificial intelligence Cloud Platform Auxiliary Group) and the control group (Non-Auxiliary Group).

The steps and contents of the gastrointestinal endoscopy examination were completed according to the working routines of the participating units in both groups. Among them, the pre-treatment of endoscopy (such as oral antifoam before gastroscopy, etc. and dregs less diet and intestinal preparation before colonoscopy, etc.) were basically the same in each participating units, and the same equipment and parameters were used to record the whole process of gastrointestinal endoscopy in both groups.

The Artificial Intelligence Cloud Platform in the intervention group can automatically complete quality control, history recognition, and auxiliary diagnosis (an alert box would appear on the display screen to alert the endoscopists) while the gastrointestinal endoscopy process is underway. At the same time, all of the above examination processes would be completed by endoscopists alone in the control group.

After the endoscopists finish writing the gastrointestinal endoscopy reports, the information on desensitized cases will be automatically uploaded to the Cloud Platform database (excluding any sensitive information that may be utilized to identify the patient), including age, gender, examination data, endoscopic examination information (time and pictures), text contents of the report plus quality control indicators. And the pathological results of biopsies during the examination will be added online by the endoscopist when their official reports are released timely.

By comparing and analyzing the results of the two groups, the researchers try to evaluate the performance of the Gastrointestinal Endoscopy Artificial Intelligence Cloud Platform according to the diagnosis rate of early gastrointestinal tract cancer (Primary outcomes) and indicators of quality control of gastrointestinal endoscopy (Secondary outcomes).

Eligibility criteria: Inclusion Criteria:

* From the beginning to the end of the study, patients who received gastroscopy and colonoscopy due to confirmed clinical indications were admitted to Beijing Aerospace General Hospital, Beijing Fangshan District Liangxiang Hospital, People's Hospital of Beijing Daxing District, Gucheng Country Hospital of Hebei Province, and Nanhe Country Hospital of Hebei Province.
* After fully informing and answering the questions, the endoscopic examination with Gastrointestinal Endoscopy Artificial Intelligence Cloud Platform can be accepted, and a signed informed consent form can be provided.

Exclusion Criteria:

* Patients who refuse to participate in this study;
* Patients with intolerance or contraindications to endoscopic examination, such as severe cardiopulmonary diseases, coagulation disorders, or a total of platelet less than 50\*10\^9/L.

Primary outcomes:
measure: Diagnosis rate of early gastrointestinal cancer.
timeFrame: two years
Secondary outcomes:
measure: Indicators for Quality Control of gastroscopy
timeFrame: two years
measure: Indicators for Quality Control of colonoscopy
timeFrame: two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Aiming Yang, M.D.
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College Hospital
name: Shengyu Zhang
role: PRINCIPAL_INVESTIGATOR
References: