Gastrointestinal DiseaseNCT04903444
Development and Validation of an Artificial Intelligence-based Biliary Stricture Navigation System in MRCP-based ERCP
A study testing Artificial intelligence assistant system in people with Gastrointestinal Disease and Endoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Disease, Endoscopy, Artificial Intelligence
- What is being tested?
- Artificial intelligence assistant system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Clinical trials
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin hospital of Wuhan University
Wuhan, Hubei, 430000
Honggang Yu, Doctor, +862788041911, whdxrmyy@126.com
About this study
Official title: A Single-center Study on the Effectiveness and Safety of Artificial Intelligence Assisted System in Clinical Application of Endoscopic Retrograde Cholangiopancreatography
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.
Read the detailed description
585/5000 Biliary stricture can be divided into benign biliary stricture and malignant biliary stricture, and malignant hilar biliary obstruction is the one of the common cause. Since there is no specific early screening method for malignant hilar biliary obstruction at present and most patients have no obvious clinical symptoms in the early stage, most patients are already in the advanced stage when they are first diagnosed. Advanced malignant hilar biliary obstruction cannot undergo resection surgery, whose first choice for the treatment is palliative endoscopic biliary drainage.Biliary drainage can relieve jaundice, pruritus and other symptoms due to cholestasis. However,before the narrow segment was placed the stent, the contrast agent could not pass through the narrow segment and the bile duct above the narrow segment could not be seen.So it was difficult for doctors to determine the direction of the guide wire and the position of the stent. In addition, indiscriminate application of the contrast agent may cause outflow obstruction leading to infection. However, there is no relevant research to solve these problems.
MRCP is the preferred examination method of pancreatic and bile duct diseases. Therefore, MRCP should be routinely performed before patients are treated with ERCP. At present, MRCP is in supine position, and ERCP is in prone position. Different positions lead to differences in the morphology of MRCP and the bile duct on ERCP.So preoperative MRCP in supine position has limited role in advising physicians on the morphology of the bile duct. Therefore, MRCP in the prone position is more favorable for endoscopists to perform ERCP .
In recent years, deep learning algorithms have been continuously developed and increasingly mature.They have been gradually applied to the medical field. Computer vision is a science that studies how to make machines "see". Through deep learning, camera and computer can replace human eyes to carry out machine vision such as target recognition, tracking and measurement.Interdisciplinary cooperation in the field of medical imaging and computer vision is also one of the research hotspots in recent years. At present, it is mainly applied to the automatic identification and detection of lesions and quality control, and has achieved good results. It can assist doctors to find lesions, make disease diagnosis and standardize doctors' operations, so as to improve the quality of doctors' operations.With mature technical support, it has a good prospect and application value to develop endoscopic operating system for lesion detection and quality control based on artificial intelligence methods such as deep learning.
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.
- Conditions
- Gastrointestinal Disease, Endoscopy, Artificial Intelligence, Endoscopic Retrograde Cholangiopancreatography
- Being tested
- Artificial intelligence assistant system
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence assistant systemDevice
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 .
| Study group | Role | What they receive |
|---|---|---|
| with AI navigation system | Experimental | 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.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. Receives: Device: Artificial intelligence assistant system |
| without AI navigation system | No intervention | The 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
The time of performing ERCP
Measured: During procedure
Secondary outcomes (8)
Intersection over Union of bile duct segmentation
Intersection over Union of bile ducts predicted by artificial intelligence devices and actual bile ducts
Measured: A month
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
Measured: 6 month
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.
Measured: During procedure
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.
Measured: Until discharge assessed up to 14 days
Fluoroscopy time
The sum of the total X ray fluoroscopy time during the whole procedure.
Measured: During procedure
Total amount of contrast medium
Total amount of contrast medium during the whole procedure.
Measured: During procedure
The difference of the area of bile duct visualization in different position
The area of bile duct visualization of MRCP in different position
Measured: During procedure
The difference in the time required to perform MRCP in different position
The difference in the time required to perform MRCP in different position
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start27 May 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Honggang Yu Yu, Doctor, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903444
- Sponsor's protocol ID
- EA-19-003-22
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study on the Effectiveness and Safety of Artificial Intelligence Assisted System in Clinical Application of Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT04903444
- Acronym / sponsor ID
- EA-19-003-22
- Conditions
- Gastrointestinal Disease, Endoscopy, Artificial Intelligence, Endoscopic Retrograde Cholangiopancreatography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
585/5000 Biliary stricture can be divided into benign biliary stricture and malignant biliary stricture, and malignant hilar biliary obstruction is the one of the common cause. Since there is no specific early screening method for malignant hilar biliary obstruction at present and most patients have no obvious clinical symptoms in the early stage, most patients are already in the advanced stage when they are first diagnosed. Advanced malignant hilar biliary obstruction cannot undergo resection surgery, whose first choice for the treatment is palliative endoscopic biliary drainage.Biliary drainage can relieve jaundice, pruritus and other symptoms due to cholestasis. However,before the narrow segment was placed the stent, the contrast agent could not pass through the narrow segment and the bile duct above the narrow segment could not be seen.So it was difficult for doctors to determine the direction of the guide wire and the position of the stent. In addition, indiscriminate application of the contrast agent may cause outflow obstruction leading to infection. However, there is no relevant research to solve these problems.
MRCP is the preferred examination method of pancreatic and bile duct diseases. Therefore, MRCP should be routinely performed before patients are treated with ERCP. At present, MRCP is in supine position, and ERCP is in prone position. Different positions lead to differences in the morphology of MRCP and the bile duct on ERCP.So preoperative MRCP in supine position has limited role in advising physicians on the morphology of the bile duct. Therefore, MRCP in the prone position is more favorable for endoscopists to perform ERCP .
In recent years, deep learning algorithms have been continuously developed and increasingly mature.They have been gradually applied to the medical field. Computer vision is a science that studies how to make machines "see". Through deep learning, camera and computer can replace human eyes to carry out machine vision such as target recognition, tracking and measurement.Interdisciplinary cooperation in the field of medical imaging and computer vision is also one of the research hotspots in recent years. At present, it is mainly applied to the automatic identification and detection of lesions and quality control, and has achieved good results. It can assist doctors to find lesions, make disease diagnosis and standardize doctors' operations, so as to improve the quality of doctors' operations.With mature technical support, it has a good prospect and application value to develop endoscopic operating system for lesion detection and quality control based on artificial intelligence methods such as deep learning.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with AI navigation system | Experimental | Device: Artificial intelligence assistant systemThe 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 intervention | –The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial intelligence assistant systemThe 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 . | Device | with AI navigation system |
Primary outcome
Procedure time
Time frame: During procedure
The time of performing ERCP
8 secondary outcomes
Intersection over Union of bile duct segmentation
Time frame: A month
Intersection over union of bile duct matching model:
Time frame: 6 month
Success rate of stent placement
Time frame: During procedure
Rate of adverse events
Time frame: Until discharge assessed up to 14 days
Fluoroscopy time
Time frame: During procedure
Total amount of contrast medium
Time frame: During procedure
The difference of the area of bile duct visualization in different position
Time frame: During procedure
The difference in the time required to perform MRCP in different position
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Honggang Yu Yu, Doctor principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence assistant system in people with Gastrointestinal Disease and Endoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Honggang Yu, Doctor (+862788041911, whdxrmyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.