Development and Validation of an Artificial Intelligence-based Biliary Stricture Navigation System in MRCP-based ERCP
A Single-center Study on the Effectiveness and Safety of Artificial Intelligence Assisted System in Clinical Application of Endoscopic Retrograde Cholangiopancreatography
1 other identifier
interventional
62
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJune 4, 2021
May 1, 2021
1 year
May 17, 2021
June 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Procedure time
The time of performing ERCP
During procedure
Secondary Outcomes (8)
Intersection over Union of bile duct segmentation
A month
Intersection over union of bile duct matching model:
6 month
Success rate of stent placement
During procedure
Rate of adverse events
Until discharge assessed up to 14 days
Fluoroscopy time
During procedure
- +3 more secondary outcomes
Study Arms (2)
with AI navigation system
EXPERIMENTALThe endoscopists in the experimental group will be assisted by AI system, which can instruct the direction of guide wire and the position of stent placement in real time. The system is an non-invasive AI system.All patients underwent MRCP in the prone position prior to ERCP. A round box with a diameter of 2mm filled with water was pasted next to the patient's spine at the level of angulus inferior scapulae during MRCP, and a sheet metal with a diameter of 2mm was pasted at the same area during ERCP.
without AI navigation system
NO INTERVENTIONThe endoscopists in the contrpl group performs ERCP routinely without special prompts.All patients underwent MRCP in the prone position prior to ERCP. A round box with a diameter of 2mm filled with water was pasted next to the patient's spine at the level of angulus inferior scapulae during MRCP, and a sheet metal with a diameter of 2mm was pasted at the same area during ERCP.
Interventions
The endoscopists in the experimental group will be assisted by AI system, which can instruct the direction of guide wire and the position of stent placement in real time. The system is an non-invasive AI system .
Eligibility Criteria
You may qualify if:
- 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.
- 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:
- Able to complete MRCP in prone position;
- 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:
- Able to complete MRCP in prone position;
- Patients requiring biliary drainage by ERCP due to malignant hilar biliary obstruction.
You may not qualify if:
- 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；
- Clinical trials
- In addition to the criteria mentioned in the above, the clinical trial must not meet any of the following criteria:
- Previous gastrectomy;
- Stent replacement;
- Pyloric or duodenal obstruction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin hospital of Wuhan University
Wuhan, Hubei, 430000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Honggang Yu Yu, Doctor
Renmin Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
May 26, 2021
Study Start
May 27, 2021
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
June 4, 2021
Record last verified: 2021-05