A Multicenter Prospective Observational Study of Computer-aided Risk Perception and Prognosis Prediction in the Whole Process of Laparoscopic Hepatobiliary and Pancreatic Surgery

October 16, 2024 updated by: Nanfang Hospital, Southern Medical University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Department of hepatobiliary surgery, Nanfang Hospital, Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year
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 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety indicators
Time Frame: 1 years
According to different surgical methods and operations, the postoperative adverse events were counted, including laboratory data, vital signs, image data, etc.
1 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness of image recognition
Time Frame: 1 years
Including the recognition accuracy of artificial intelligence for key operations of endoscopic surgery; High risk process identification accuracy;
1 years
Relevant indicators of intraoperative scene reconstruction by computer
Time Frame: 1 years
Including intraoperative scene reconstruction image perception similarity; Preoperative and intraoperative organ 2D-3D registration error
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital, Southern Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangdong Provincial Hospital of Traditional Chinese Medicine
Chinese University of Hong Kong
The Affiliated Hospital Of Southwest Medical University
Jiangmen Central Hospital
Shenzhen Third People's Hospital
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
Affiliated Hospital of Guangdong Medical University
Huzhou Central Hospital，Affiliated Hospital of Huzhou University
Shenzhen Second People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kai Wang, Department of hepatobiliary surgery, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2024-403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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