Development of a Set of Auxiliary Decision-making System for the Perioperative Period of Hepatectomy Based on Static CT and Artificial Intelligence.

NCT07056270 | Not Yet Recruiting DMC

• 1 other identifier: CTLIVERai
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will prospectively recruit patients with chronic liver disease and liver cancer for static CT scans to establish a high-definition CT database. Combining clinical data and pathological information, artificial intelligence technology will be utilized to construct models for assessing liver function and liver cirrhosis, as well as predicting microvascular invasion (MVI).

Conditions

Liver Cirrhosis; Liver Cancer

Keywords

liver cancer; liver cirrhosis; liver resection; microvascular invasion; liver function; static CT

Outcome Measures

Primary Outcomes (3)

• microvascular invasion

  microvascular invasion based on pathology

  7 days after surgery

• liver cirhosis

  liver cirhosis according to laennec grading system

  7 days after surgery

• liver function

  liver funcion based Child-Pugh grading system

  1 day before static CT scanning

Study Arms (1)

Static CT group

Patients with chronic liver disease and liver cancer receive static CT scans

Other: static CT scans

Interventions

static CT scans OTHER

Patients with chronic liver disease and liver cancer received static CT scans before hepatectomy to establish a high-definition CT database.

Static CT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are clinically diagnosed with primary liver cancer and other space-occupying liver lesions preoperatively and are planned for surgical resection, or those with underlying liver diseases and cirrhosis

You may qualify if:

• Patients who are clinically diagnosed with primary liver cancer and other space-occupying liver lesions preoperatively and are planned for surgical resection, or those with underlying liver diseases and cirrhosis;
• Aged 18-75 years;
• Willing to participate in this study and have signed the informed consent.

You may not qualify if:

• Planned or unplanned pregnancy and pregnant women;
• Glomerular filtration rate (GFR) ≤60 ml/min;
• History of contrast media allergy.

Sponsors & Collaborators

• Tongji Hospital: lead
• Suzhou Institute of Biomedical Engineering and Technology of the Chinese Academy of Sciences: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical resection specimens of liver cancer

MeSH Terms

Conditions

Liver Cirrhosis; Liver Neoplasms

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Xiaoping Chen, M.D.

  Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Central Study Contacts

Hongwei Cheng, M.D.

CONTACT

+8613871459541; chengqi@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Department of Surgery

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share