Artificial Intelligence Clinical Trial
Official title:
A Single-center Study on the Effectiveness and Safety of Artificial Intelligence Assisted System in Clinical Application of Endoscopic Retrograde Cholangiopancreatography
NCT number | NCT04903444 |
Other study ID # | EA-19-003-22 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 27, 2021 |
Est. completion date | July 1, 2022 |
In this study, the investigators proposed an artificial intelligence-based biliary stricture navigation system in MRCP-based ERCP, which can instruct the direction of guide wire and the position of stent placement in real time.
Status | Recruiting |
Enrollment | 62 |
Est. completion date | July 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Bile duct segmentation model 1) Male or female aged 18 or above; 2) Who needs ERCP,MRCP and its related tests are needed to further define the characteristics of digestive tract diseases; 3)The images of MRCP and ERCP are clear; 4) Able to read, understand and sign informed consent; 5) The investigator believes that the subject can understand the process of the clinical study and is willing and able to complete all the study procedures and follow-up visits and cooperate with the study procedures. 2. Bile duct matching model In addition to the criteria mentioned in the bile duct segmentation model, the bile duct matching model should also meet the following criteria: 1. Able to complete MRCP in prone position; 2. Bile ducts are almost completely visible in MRCP and ERCP. (3) Clinical trials In addition to the criteria mentioned in the bile duct segmentation model, the clinical trials should also meet the following criteria: 1. Able to complete MRCP in prone position; 2. Patients requiring biliary drainage by ERCP due to malignant hilar biliary obstruction. Exclusion Criteria: 1. Bile duct segmentation model and bile duct matching model 1)Has participated in other clinical trials, signed the informed consent and was in the follow-up period of other clinical trials; 2) Drug or alcohol abuse or psychological disorder in the last 5 years; 3) Patients in pregnancy or lactation; 4) The investigator considers that the subjects were not suitable for MRCP, ERCP and related tests; 5)A high-risk diseases or other special conditions that the investigator considers inappropriate for the subject to participate in a clinical trial; 2. Clinical trials In addition to the criteria mentioned in the above, the clinical trial must not meet any of the following criteria: 1. Previous gastrectomy; 2. Stent replacement; 3. Pyloric or duodenal obstruction. |
Country | Name | City | State |
---|---|---|---|
China | Renmin hospital of Wuhan University | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Renmin Hospital of Wuhan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure time | The time of performing ERCP | During procedure | |
Secondary | Intersection over Union of bile duct segmentation | Intersection over Union of bile ducts predicted by artificial intelligence devices and actual bile ducts | A month | |
Secondary | Intersection over union of bile duct matching model: | Intersection over Union of the bile ducts generated by the AI device and the actual bile ducts in ERCP | 6 month | |
Secondary | Success rate of stent placement | The number of successful patients is the numerator, and the total number of patients with stent placement is the denominator. | During procedure | |
Secondary | Rate of adverse events | The number of patients who experienced adverse events was numerator, and the total number of patients undergoing stent placement was denominator. | Until discharge assessed up to 14 days | |
Secondary | Fluoroscopy time | The sum of the total X ray fluoroscopy time during the whole procedure. | During procedure | |
Secondary | Total amount of contrast medium | Total amount of contrast medium during the whole procedure. | During procedure | |
Secondary | The difference of the area of bile duct visualization in different position | The area of bile duct visualization of MRCP in different position | During procedure | |
Secondary | The difference in the time required to perform MRCP in different position | The difference in the time required to perform MRCP in different position | During procedure |
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