Gastrointestinal DiseaseNCT04719117
Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
An observational study of Gastrointestinal Disease and Endoscopy, run by Renmin Hospital of Wuhan University at 3 sites in China.
Trial summary
In this study, the investigators proposed a prospective study about the effectiveness of artificial intelligence system for Retrograde cholangiopancreatography. The subjects would be include in an analyses groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Disease, Endoscopy, Artificial Intelligence
- How many people
- 150 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2020to 31 Dec 2021
- Phase
- Observational
- 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
Study population: Patients who meet the admission criteria for endoscopic examination.
Who may be able to join
- Who needs ERCP and its related tests are needed to further define the characteristics of digestive tract diseases
- Able to read, understand and sign informed consent
- The investigator believes that the subject can understand the process of the clinical study, is willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures
- Patients with a natural duodenal papilla
Who cannot join
- Has participated in other clinical trials, signed informed consent and is in the follow-up period of other clinical trials
- Has drug or alcohol abuse or mental disorder in the last 5 years
- Women who are pregnant or lactating
- Subjects with previous biliary sphincterotomy
- The investigator determined that subjects were not suitable for ERCP and related tests
- A high-risk disease or other special condition that the investigator considers inappropriate for the subject to participate in a clinical trial
Show all 10Show fewer
- Patients with known more severe pancreatic head carcinoma
- Patients with acute pancreatitis within 3 days
- Biliary stent replacement or removal did not occur after pancreatic angiography as expected
- Acute cardiovascular and cerebrovascular diseases
Trial locations and contacts
3 sites in 1 country.
China3 sites
People's Hospital
Shanghai, Shanghai Municipality, 200072
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Renmin hospital
Wuhan, Hubei, 430000
About this study
Official title: A Multicentric Validation Study on the Effectiveness and Safety of Artificial Intelligence Assisted System in Clinical Application of Retrograde Cholangiopancreatography
In this study, the investigators proposed a prospective study about the effectiveness of artificial intelligence system for Retrograde cholangiopancreatography. The subjects would be include in an analyses groups. The AI-assisted system helps endoscopic physicians estimate the difficulty of Endoscopic retrograde cholangiopancreatography for choledocholithiasis and make recommendations based on guidelines and difficulty scores. The investigators used the stone removal times, success rate of stone extraction and Operating time to reflect the difficulty of the operation, and evaluated whether the results of the AI system were correct.
Read the detailed description
Endoscopy is a routine and reliable method for the diagnosis of digestive tract diseases.Common endoscopy are gastroscopy, colonoscopy, capsule endoscopy and enteroscopy, ultrasonic gastroscopy, after ercp and other related technology, can be used in early gastric cancer and peptic ulcer, esophageal varices, the stomach before lesion, intestinal polyps and adenomas and colorectal lesions, inflammatory bowel disease, pancreas disease, biliary tract disease diagnosis and follow-up.At present, digestive endoscopy almost covers the diagnosis of the vast majority of diseases of the digestive tract, and diseases of the digestive system that cannot be directly seen by endoscopy can also be realized through endoscopic-based technologies such as endoscopy and ERCP (here the investigators collectively refer to endoscopy), so as to achieve the coverage of the whole digestive system.It can be seen that digestive endoscopy is of great significance for the diagnosis of digestive diseases and the development of digestive field.
With the popularization of these related technologies, the number of endoscopy increased rapidly, which further increased the workload of endoscopists. The operation of endoscopy by high-load endoscopists would reduce the quality of endoscopy, which is prone to problems such as incomplete examination coverage and incomplete detection of lesions.In digestive endoscopy, there are some problems in China, such as lack of endoscopic physicians and uneven distribution, and the quality of endoscopy is not up to standard. These problems need to be solved urgently in order to relieve the pain of patients, save medical resources, save the time and money of patients, and ensure the quality of patients' medical treatment.
In 2015, the proposal of deep learning brought great changes to the field of artificial intelligence, which made the development of artificial intelligence leap to a new level.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 a prospective study about the effectiveness of artificial intelligence system for Retrograde cholangiopancreatography. The subjects would be include in an analyses groups. The AI-assisted system helps endoscopic physicians estimate the difficulty of Endoscopic retrograde cholangiopancreatography for choledocholithiasis and make recommendations based on guidelines and difficulty scores. The investigators used the stone removal times, success rate of stone extraction and Operating time to reflect the difficulty of the operation, and evaluated whether the results of the AI system were correct.
- Conditions
- Gastrointestinal Disease, Endoscopy, Artificial Intelligence, Cholangiopancreatography, Endoscopic Retrograde
- Keywords
- Deep Learning
- Medical subject headings
- Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stone removal operations
The number of times that the stoning balloon and the stoning net were pulled out of the lumen during the stoning process.
Measured: A year
Secondary outcomes (5)
the accuracy of the measurement
The diameter of the stone (or the width of the lower end of the bile duct) measured by the machine is consistent with the doctor's degree.Accurate DuDu = | machine measurement results - the doctor gold standard measurement results | / doctor gold standard measurements.
Measured: A year
Stone clearance success rate
Whether the stones have been removed successfully
Measured: A year
the sensitivity of the prediction of the stone
That is, the sensitivity of the machine to predict the number of stones.Sensitivity = the number of calculi correctly predicted by the machine/the number of actual calculi.
Measured: A year
the operate time
Refers to the time from the successful intubation of the duodenal papilla guide wire to the beginning of endoscopic withdrawal.
Measured: During surgery
the removal stone time
Refers to the time from the successful intubation of the duodenal papilla guide wire to the beginning of endoscopic withdrawal.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Sep 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Honggang Yu, Doctor, Principal investigator, Wuhan University Renmin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719117
- Sponsor's protocol ID
- EA-19-006-08
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang L, Xu Y, Chen J, Liu F, Wu D, Zhou W, Wu L, Pang T, Huang X, Zhang K, Yu H. An artificial intelligence difficulty scoring system for stone removal during ERCP: a prospective validation. Endoscopy. 2023 Jan;55(1):4-11. doi: 10.1055/a-1850-6717. Epub 2022 May 12.
PubMed 35554877
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Validation Study on the Effectiveness and Safety of Artificial Intelligence Assisted System in Clinical Application of Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT04719117
- Acronym / sponsor ID
- EA-19-006-08
- Conditions
- Gastrointestinal Disease, Endoscopy, Artificial Intelligence, Cholangiopancreatography, Endoscopic Retrograde
- Keywords
- Deep Learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Jan 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 a prospective study about the effectiveness of artificial intelligence system for Retrograde cholangiopancreatography. The subjects would be include in an analyses groups. The AI-assisted system helps endoscopic physicians estimate the difficulty of Endoscopic retrograde cholangiopancreatography for choledocholithiasis and make recommendations based on guidelines and difficulty scores. The investigators used the stone removal times, success rate of stone extraction and Operating time to reflect the difficulty of the operation, and evaluated whether the results of the AI system were correct.
Detailed description
Endoscopy is a routine and reliable method for the diagnosis of digestive tract diseases.Common endoscopy are gastroscopy, colonoscopy, capsule endoscopy and enteroscopy, ultrasonic gastroscopy, after ercp and other related technology, can be used in early gastric cancer and peptic ulcer, esophageal varices, the stomach before lesion, intestinal polyps and adenomas and colorectal lesions, inflammatory bowel disease, pancreas disease, biliary tract disease diagnosis and follow-up.At present, digestive endoscopy almost covers the diagnosis of the vast majority of diseases of the digestive tract, and diseases of the digestive system that cannot be directly seen by endoscopy can also be realized through endoscopic-based technologies such as endoscopy and ERCP (here the investigators collectively refer to endoscopy), so as to achieve the coverage of the whole digestive system.It can be seen that digestive endoscopy is of great significance for the diagnosis of digestive diseases and the development of digestive field.
With the popularization of these related technologies, the number of endoscopy increased rapidly, which further increased the workload of endoscopists. The operation of endoscopy by high-load endoscopists would reduce the quality of endoscopy, which is prone to problems such as incomplete examination coverage and incomplete detection of lesions.In digestive endoscopy, there are some problems in China, such as lack of endoscopic physicians and uneven distribution, and the quality of endoscopy is not up to standard. These problems need to be solved urgently in order to relieve the pain of patients, save medical resources, save the time and money of patients, and ensure the quality of patients' medical treatment.
In 2015, the proposal of deep learning brought great changes to the field of artificial intelligence, which made the development of artificial intelligence leap to a new level.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 a prospective study about the effectiveness of artificial intelligence system for Retrograde cholangiopancreatography. The subjects would be include in an analyses groups. The AI-assisted system helps endoscopic physicians estimate the difficulty of Endoscopic retrograde cholangiopancreatography for choledocholithiasis and make recommendations based on guidelines and difficulty scores. The investigators used the stone removal times, success rate of stone extraction and Operating time to reflect the difficulty of the operation, and evaluated whether the results of the AI system were correct.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the admission criteria for endoscopic examination.
Key inclusion criteria (4 listed)
- Who needs ERCP and its related tests are needed to further define the characteristics of digestive tract diseases
- Able to read, understand and sign informed consent
- The investigator believes that the subject can understand the process of the clinical study, is willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures
- Patients with a natural duodenal papilla
Key exclusion criteria (10 listed)
- Has participated in other clinical trials, signed informed consent and is in the follow-up period of other clinical trials
- Has drug or alcohol abuse or mental disorder in the last 5 years
- Women who are pregnant or lactating
- Subjects with previous biliary sphincterotomy
- The investigator determined that subjects were not suitable for ERCP and related tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of stone removal operations
Time frame: A year
The number of times that the stoning balloon and the stoning net were pulled out of the lumen during the stoning process.
5 secondary outcomes
the accuracy of the measurement
Time frame: A year
Stone clearance success rate
Time frame: A year
the sensitivity of the prediction of the stone
Time frame: A year
the operate time
Time frame: During surgery
the removal stone time
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 35554877Huang L, Xu Y, Chen J, Liu F, Wu D, Zhou W, Wu L, Pang T, Huang X, Zhang K, Yu H. An artificial intelligence difficulty scoring system for stone removal during ERCP: a prospective validation. Endoscopy. 2023 Jan;55(1):4-11. doi: 10.1055/a-1850-6717. Epub 2022 May 12.
Related trials for Gastrointestinal Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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, Doctor principal investigator
Wuhan University Renmin Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Disease and Endoscopy, run by Renmin Hospital of Wuhan University at 3 sites 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 4 inclusion and 10 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of stone removal operations (time frame: A year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04719117, which also lists 1 linked publication.
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 22 Jan 2021.