An interventional study of The Artificial intelligence Cloud Platform in Diagnoses Disease, Quality Control and Endoscopy, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Diagnostic
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.
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).
Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients in this group would be examined by endoscopists with the Artificial intelligence Cloud Platform Auxiliary Device launched with gastrointestinal endoscopy.
Device: The Artificial intelligence Cloud Platform
The patients in this group would be examined by endoscopists with the gastrointestinal endoscopy alone.
The Artificial intelligence Cloud Platform would be used as the auxiliary device for endoscopists during the whole endoscopic examination to help endoscopists complete the quality control, indicate potential lesions, and aid in diagnosis.
Diagnosis rate of early gastrointestinal cancer.
The number of patients diagnosed with early gastrointestinal cancer is divided by the total number of patients undergoing digestive endoscopy of the intervention group with Artificial Intelligence Cloud Platform Auxiliary and the control group with nothing. The Early Gastrointestinal cancer in this study is defined as ① early gastric cancer and ② progressive adenoma of the colon and serrated adenoma. The pathology of biopsies will be referred to the official report of the pathologists in the participating centers, which shall be filled in and uploaded to the cloud platform.
Time frame: two years
Indicators for Quality Control of gastroscopy
The principle of quality control for gastroscopy in this part is 'no neglected area for observation in the stomach'. The artificial intelligence system can automatically identify the corresponding sites (according to the standard anatomical sites) of the photos taken under the gastroscope and mark them as green on the stomach schematic diagram. After all the sites are observed and corresponding photos are taken, the stomach schematic diagram totally turns green, which would be regarded as no blind sites.
Time frame: two years
Indicators for Quality Control of colonoscopy
The quality control of colonoscopy is assessed with the following criteria: ① Quality of bowel preparations, which is evaluated with the Boston score; ② Withdrawal time, which should be no less than 6 minutes from the time of the first cecum image under colonoscopy to the time of the last rectum image.
Time frame: two years
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking Union Medical College Hospital