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

NCT06647264 | Enrolling By Invitation DMC

• 1 other identifier: NFEC-2024-403
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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 surgery (such as bleeding, blocking, tumor location, anastomosis, etc.), and decision-making assistance

Conditions

Hepatocellular Carcinomas; Cholecystectomy, Laparoscopic; Hepatectomy; Pancreatoduodenectomy

Keywords

artificial intelligence; risk perception; Laparoscopic technique; Hepatobiliary pancreatic

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1 years

Secondary Outcomes (1)

• Safety indicators

  1 years

Other Outcomes (2)

• Effectiveness of image recognition

  1 years

• Relevant indicators of intraoperative scene reconstruction by computer

  1 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• The Affiliated Hospital Of Southwest Medical University: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator
• Huzhou Central Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Jiangmen Central Hospital: collaborator
• Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences: collaborator
• Chinese University of Hong Kong: collaborator
• Shenzhen Second People's Hospital: collaborator
• Shenzhen Third People's Hospital: collaborator

Study Sites (1)

Department of hepatobiliary surgery, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Kai Wang

  Department of hepatobiliary surgery, Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 17, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 17, 2024

Record last verified: 2024-10

Locations

CN (1)