Hepatocellular CarcinomasNCT06647264
A Multicenter Prospective Observational Study of Computer-aided Risk Perception and Prognosis Prediction in the Whole Process of Laparoscopic Hepatobiliary and Pancreatic Surgery
An observational study of Hepatocellular Carcinomas and Cholecystectomy, Laparoscopic, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Artificial intelligence technology is used to realize high-quality 3D scene reconstruction, whole process segmentation, scene activity understanding for common surgery guidance in hepatobiliary surgery, as well as intelligent identification, perception, early warning of key events in the whole process of endoscopic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinomas, Cholecystectomy, Laparoscopic, Hepatectomy
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Jan 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects of this study were patients admitted to the hepatobiliary surgery department of each center for surgical treatment with complete surgical video
Who may be able to join
- Voluntarily sign informed consent Patients who underwent hepatectomy and cholecystectomy and were followed up in the research center hospitals from July 2024 to December 2028 Complete case, imaging and operation video data
Who cannot join
- Patients who had other diseases before surgery, which may affect the results of the study Patients who developed postoperative complications but could not confirm their relevance to surgery According to the judgment of the researcher, it is not suitable to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of hepatobiliary surgery, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Artificial intelligence technology is used to realize high-quality 3D scene reconstruction, whole process segmentation, scene activity understanding for common surgery guidance in hepatobiliary surgery, as well as intelligent identification, perception, early warning of key events in the whole process of endoscopic surgery (such as bleeding, blocking, tumor location, anastomosis, etc.), and decision-making assistance
Read the detailed description
Endoscopic surgery is the most important and commonly used minimally invasive surgery technology in the field of modern surgery, especially in hepatobiliary surgery, which has become one of the conventional diagnosis and treatment methods of surgery. Compared with traditional open surgery, it has smaller trauma, faster recovery time and lower complication rate. However, the limited visual field of surgical observation caused by the narrow surgical space and the difficulty of immediate identification of key events in the surgical scene greatly increase the difficulty and complexity of endoscopic surgery. Its safety and efficacy largely depend on the precise perception of the complex surgical field and the ability to handle key events during the operation. Therefore, combining modern image processing technology and machine learning algorithm, it is particularly urgent to develop a system that can provide real-time dynamic perception and safety warning of endoscopic surgery. Although domestic and foreign scholars have carried out a lot of research on endoscopic video dynamic perception and safety warning, the current research only focuses on local problems in the surgical process. Traditional image processing technology is often difficult to meet the needs of highly sensitive to real-time dynamic information of surgery, it is difficult to achieve efficient three-dimensional reconstruction of the surgical scene, it can not provide the key anatomical structure information of human organs, and it can not accurately detect the key events in the operation process. For endoscopic surgery, further research is urgently needed to realize the video dynamic perception and safety early warning system of endoscopic surgery, and assist doctors to achieve safe, accurate and efficient endoscopic surgery. In recent years, with the continuous progress of computer graphics and image technology and machine learning methods, the dynamic perception and safety early warning system of endoscopic surgery video will develop towards higher automation and intelligence. Future research may focus on improving the real-time and accuracy of the algorithm, as well as how to better integrate artificial intelligence technology into the clinical operation process, realize the real-time perception and safety warning of endoscopic surgery, and improve the efficiency and safety of surgery through the comprehensive analysis and understanding of endoscopic surgery process. Due to the complexity and variability of the endoscopic surgery environment, it is difficult to identify the key anatomical structures of organs during the operation, and it is very dependent on the subjective empirical judgment of the surgeon. There is a lack of objective instructions. It is particularly important to develop a machine learning method that can detect, perceive and recognize the key anatomical structures in real time during the operation. At the same time, the workflow of endoscopic surgery is fine and complex, so it is very necessary to comprehensively analyze and detect the key events and activity scenes in the video of endoscopic surgery through the AI auxiliary system. In addition, the realization of intraoperative hidden target area augmented reality surgery navigation needs to be carried out on the accurate dynamic organ surface reconstruction and non rigid registration results. However, the complex and narrow field of view endoscopic video further reduces the accuracy of non rigid registration, making augmented reality assisted endoscopic surgery extremely challenging. In conclusion, how to solve the problem of real-time dynamic perception and safety warning of endoscopic video is the key to achieve safe, accurate and efficient endoscopic surgery in clinic. Through the research and application of endoscopic video real-time dynamic perception and safety early warning technology, it can realize real-time dynamic perception, key event early warning, prediction of the location of invisible lesions and other decision-making information in various high-risk and difficult endoscopic surgery processes, and assist doctors to \"see\", \"see clearly\", \"see accurately\" in the operation process, so as to further improve the efficiency and safety of endoscopic surgery. At the same time, based on the above content, the success of the treatment of some key fields in surgery will greatly affect the prognosis of patients and the quality of life of patients. Another purpose of this study is to more comprehensively and objectively understand the incidence, risk factors, prevention and treatment of intraoperative and postoperative complications after evaluation combined with surgical video analysis, so as to provide clinicians with a more scientific treatment plan and guidance.
- Conditions
- Hepatocellular Carcinomas, Cholecystectomy, Laparoscopic, Hepatectomy, Pancreatoduodenectomy
- Keywords
- artificial intelligence, risk perception, Laparoscopic technique, Hepatobiliary pancreatic
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Group according to the characteristics of different cases (for example), collect the basic information of all included patients and clinical case data, and make descriptive statistical analysis: the basic information of patients, operation methods, operation time, etc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main effectiveness indicators
The 1-year progression free survival rate of patients with malignant tumors were evaluated based on RECIST v1.1. The computer then predicts according to the complications, surgical videos, and pre -, intra -, and post-operative examinations, and compares them with the real situation
Measured: 1 year
Main effectiveness indicators
The 1-year overall survival rate of patients with malignant tumors were evaluated. The computer then predicts according to the complications, surgical videos, and pre -, intra -, and post-operative examinations, and compares them with the real situation
Measured: 1 years
Secondary outcomes (1)
Safety indicators
According to different surgical methods and operations, the postoperative adverse events were counted, including laboratory data, vital signs, image data, etc.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomasStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of Guangdong Medical University, Huzhou Central Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Jiangmen Central Hospital, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences, Chinese University of Hong Kong, Shenzhen Second People's Hospital, Shenzhen Third People's Hospital
- Responsible party
- Sponsor
- Investigators
- Kai Wang, Principal investigator, Department of hepatobiliary surgery, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647264
- Sponsor's protocol ID
- NFEC-2024-403
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Study of Computer-aided Risk Perception and Prognosis Prediction in the Whole Process of Laparoscopic Hepatobiliary and Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT06647264
- Acronym / sponsor ID
- NFEC-2024-403
- Conditions
- Hepatocellular Carcinomas, Cholecystectomy, Laparoscopic, Hepatectomy, Pancreatoduodenectomy
- Keywords
- artificial intelligence, risk perception, Laparoscopic technique, Hepatobiliary pancreatic
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of Guangdong Medical University, Huzhou Central Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Jiangmen Central Hospital, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences, Chinese University of Hong Kong, Shenzhen Second People's Hospital, Shenzhen Third People's Hospital
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 17 Oct 2024 (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.
Artificial intelligence technology is used to realize high-quality 3D scene reconstruction, whole process segmentation, scene activity understanding for common surgery guidance in hepatobiliary surgery, as well as intelligent identification, perception, early warning of key events in the whole process of endoscopic surgery (such as bleeding, blocking, tumor location, anastomosis, etc.), and decision-making assistance
Detailed description
Endoscopic surgery is the most important and commonly used minimally invasive surgery technology in the field of modern surgery, especially in hepatobiliary surgery, which has become one of the conventional diagnosis and treatment methods of surgery. Compared with traditional open surgery, it has smaller trauma, faster recovery time and lower complication rate. However, the limited visual field of surgical observation caused by the narrow surgical space and the difficulty of immediate identification of key events in the surgical scene greatly increase the difficulty and complexity of endoscopic surgery. Its safety and efficacy largely depend on the precise perception of the complex surgical field and the ability to handle key events during the operation. Therefore, combining modern image processing technology and machine learning algorithm, it is particularly urgent to develop a system that can provide real-time dynamic perception and safety warning of endoscopic surgery. Although domestic and foreign scholars have carried out a lot of research on endoscopic video dynamic perception and safety warning, the current research only focuses on local problems in the surgical process. Traditional image processing technology is often difficult to meet the needs of highly sensitive to real-time dynamic information of surgery, it is difficult to achieve efficient three-dimensional reconstruction of the surgical scene, it can not provide the key anatomical structure information of human organs, and it can not accurately detect the key events in the operation process. For endoscopic surgery, further research is urgently needed to realize the video dynamic perception and safety early warning system of endoscopic surgery, and assist doctors to achieve safe, accurate and efficient endoscopic surgery. In recent years, with the continuous progress of computer graphics and image technology and machine learning methods, the dynamic perception and safety early warning system of endoscopic surgery video will develop towards higher automation and intelligence. Future research may focus on improving the real-time and accuracy of the algorithm, as well as how to better integrate artificial intelligence technology into the clinical operation process, realize the real-time perception and safety warning of endoscopic surgery, and improve the efficiency and safety of surgery through the comprehensive analysis and understanding of endoscopic surgery process. Due to the complexity and variability of the endoscopic surgery environment, it is difficult to identify the key anatomical structures of organs during the operation, and it is very dependent on the subjective empirical judgment of the surgeon. There is a lack of objective instructions. It is particularly important to develop a machine learning method that can detect, perceive and recognize the key anatomical structures in real time during the operation. At the same time, the workflow of endoscopic surgery is fine and complex, so it is very necessary to comprehensively analyze and detect the key events and activity scenes in the video of endoscopic surgery through the AI auxiliary system. In addition, the realization of intraoperative hidden target area augmented reality surgery navigation needs to be carried out on the accurate dynamic organ surface reconstruction and non rigid registration results. However, the complex and narrow field of view endoscopic video further reduces the accuracy of non rigid registration, making augmented reality assisted endoscopic surgery extremely challenging. In conclusion, how to solve the problem of real-time dynamic perception and safety warning of endoscopic video is the key to achieve safe, accurate and efficient endoscopic surgery in clinic. Through the research and application of endoscopic video real-time dynamic perception and safety early warning technology, it can realize real-time dynamic perception, key event early warning, prediction of the location of invisible lesions and other decision-making information in various high-risk and difficult endoscopic surgery processes, and assist doctors to \"see\", \"see clearly\", \"see accurately\" in the operation process, so as to further improve the efficiency and safety of endoscopic surgery. At the same time, based on the above content, the success of the treatment of some key fields in surgery will greatly affect the prognosis of patients and the quality of life of patients. Another purpose of this study is to more comprehensively and objectively understand the incidence, risk factors, prevention and treatment of intraoperative and postoperative complications after evaluation combined with surgical video analysis, so as to provide clinicians with a more scientific treatment plan and guidance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –Group according to the characteristics of different cases (for example), collect the basic information of all included patients and clinical case data, and make descriptive statistical analysis: the basic information of patients, operation methods, operation time, etc |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects of this study were patients admitted to the hepatobiliary surgery department of each center for surgical treatment with complete surgical video
Key inclusion criteria (1 listed)
- Voluntarily sign informed consent Patients who underwent hepatectomy and cholecystectomy and were followed up in the research center hospitals from July 2024 to December 2028 Complete case, imaging and operation video data
Key exclusion criteria (1 listed)
- Patients who had other diseases before surgery, which may affect the results of the study Patients who developed postoperative complications but could not confirm their relevance to surgery According to the judgment of the researcher, it is not suitable to participate in this study
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
Main effectiveness indicators
Time frame: 1 year
The 1-year progression free survival rate of patients with malignant tumors were evaluated based on RECIST v1.1. The computer then predicts according to the complications, surgical videos, and pre -, intra -, and post-operative examinations, and compares them with the real situation
Main effectiveness indicators
Time frame: 1 years
The 1-year overall survival rate of patients with malignant tumors were evaluated. The computer then predicts according to the complications, surgical videos, and pre -, intra -, and post-operative examinations, and compares them with the real situation
1 secondary outcome
Safety indicators
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Kai Wang principal investigator
Department of hepatobiliary surgery, Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinomas and Cholecystectomy, Laparoscopic, run by Nanfang Hospital, Southern Medical 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 17 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Main effectiveness indicators (time frame: 1 year). The study lists 2 primary outcomes in all. 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 17 Oct 2024.