A Multi-center Study on the Efficacy and Safety of AI-assisted Navigation System for Biliopancreatic EUS
1 other identifier
interventional
285
1 country
2
Brief Summary
Pancreatic cancer is one of the most lethal cancers. Survival rates vary largely depending on the stage at which it is diagnosed. EUS is considered one of the most sensitive modalities for pancreatic cancer detection. To avoid a missed diagnosis of the pancreatic cancer, the continuity and integrity of EUS needs to be ensured as much as possible. The station approach in pancreatic EUS has been established as the standard scanning procedure. Complete anatomical scanning is helpful for the identification of standard stations, and its imaging findings can assist in the diagnosis of pancreatic lesions and guide patient treatment and prognosis. But EUS is highly operator-dependent and the learning curve is steep. In this study, we constructed a deep learning-based pancreatic scanning navigation system in EUS, which can assist in identifying important anatomical structures adjacent to the pancreas in real time. In order to improve the quality of EUS and reduce the missed diagnosis of pancreatic lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started May 2021
Shorter than P25 for not_applicable pancreatic-cancer
2 active sites
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 10, 2021
CompletedStudy Start
First participant enrolled
May 12, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedJuly 5, 2022
June 1, 2022
1.6 years
May 10, 2021
June 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Missed scanning rate of adjacent important anatomical structures in pancreatic endoscopic ultrasonography
It was calculated by dividing the number of important anatomy that is not scanned in the actual EUS pancreas by the number of EUS.
Six month
Secondary Outcomes (6)
Pancreatic lesions detection rate
Six month
Cholangiopancreatic duct lesions detection rate
Six month
The average number of scanning in the pancreatic standard station of endoscopic ultrasonography
Six month
Detection rate of lesions in different pancreatic standard stations of endoscopic ultrasonography
Six month
Missed scanning rate of adjacent vital anatomical structures in different pancreatic standard stations of endoscopic ultrasonography
Six month
- +1 more secondary outcomes
Study Arms (2)
EUS AI navigation system augmentation
EXPERIMENTALThe endoscopists in the experimental group will be assisted by EndoAngel, which can assist in identifying important anatomical structures adjacent to the pancreas in real time. The system is an non-invasive AI system .
without EUS AI navigation system augmentation
NO INTERVENTIONThe endoscopists in the contrpl group performs the examination routinely without special prompts.
Interventions
The endoscopists in the experimental group will be assisted by EndoAngel, which can assist in identifying important anatomical structures adjacent to the pancreas in real time. The system is an non-invasive AI system .
Eligibility Criteria
You may qualify if:
- All patients meeting the following criteria will be considered for participation in the study:
- Male or female aged 18 or above;
- EUS is needed to further clarify the characteristics of biliopancreatic diseases;
- Patients able to give informed consent were eligible to participate.
- Able and willing to comply with all study process.
You may not qualify if:
- All patients meeting the following criteria will not be considered for participation in the study:
- Has participated in other clinical trials, signed informed consent and was in the follow-up period of other clinical trials.
- Has participated in clinical trials of the drug and is in the elution period of the experimental drug or control drug.
- Drug or alcohol abuse or psychological disorder in the last 5 years.
- Patients in pregnancy or lactation.
- A history of Upper Gastrointestinal surgery.
- Patients with anatomical abnormalities of the upper gastrointestinal tract due to advanced neoplasia
- Patients in whom the presence of clearly defined vital anatomical structures cannot be observed
- Researchers believe that the patient is not suitable to participate in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Honggang 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
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 19, 2021
Study Start
May 12, 2021
Primary Completion
November 29, 2022
Study Completion
November 30, 2022
Last Updated
July 5, 2022
Record last verified: 2022-06