- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04719117
Retrograde Cholangiopancreatography AI Assisted System Validation on Effectiveness and Safety
A Multicentric Validation Study on the Effectiveness and Safety of Artificial Intelligence Assisted System in Clinical Application of Retrograde Cholangiopancreatography
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Hubei
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Wuhan, Hubei, 중국, 430000
- Renmin Hospital
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Shanghai
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Shanghai, Shanghai, 중국, 200433
- Changhai Hospital
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Shanghai, Shanghai, 중국, 200072
- People'S Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of stone removal operations
기간: A year
|
The number of times that the stoning balloon and the stoning net were pulled out of the lumen during the stoning process.
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A year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
the accuracy of the measurement
기간: A year
|
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.
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A year
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Stone clearance success rate
기간: A year
|
Whether the stones have been removed successfully
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A year
|
the sensitivity of the prediction of the stone
기간: A year
|
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.
|
A year
|
the operate time
기간: During surgery
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Refers to the time from the successful intubation of the duodenal papilla guide wire to the beginning of endoscopic withdrawal.
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During surgery
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the removal stone time
기간: During surgery
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Refers to the time from the successful intubation of the duodenal papilla guide wire to the beginning of endoscopic withdrawal.
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During surgery
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Honggang Yu, Doctor, Wuhan University Renmin Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .