Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001, China
Location status: Recruiting
Location contact
Dou-Sheng Bai, MD
CONTACT
Guo-Qing Jiang, MD
CONTACT
Guo-Qing Jiang, MD
SUB_INVESTIGATOR
NCT Number: NCT07811687
Splenectomy may relieve hypersplenism, reverse liver fibrosis, improve hepatic functional reserve, and reshape the systemic antitumor immune milieu by removing the source of negative immunomodulation. This prospective cohort study aims to enroll patients undergoing laparoscopic hepatectomy combined with splenectomy for small hepatocellular carcinoma(HCC) with a preoperative platelet count <80×10^9/L. The study will evaluate the dynamic changes in hepatic functional reserve, immune function, and risk of HCC recurrence through five post-surgical time points(3, 6, 12, 18, and 24 months after surgery). The endpoints include hepatic functional reserve(ICG-R15, Child-Pugh score, ALBI score, etc.), immune function indicators(peripheral blood lymphocyte subsets: CD4^+ T cells, CD8^+ T cells, regulatory T cells, NK cells, etc., and serum cytokine profiles), and HCC recurrence rate within 2 years after surgery(confirmed by imaging). This trial will provide evidence to optimize surgical strategies for patients with small HCC complicated with hypersplenism.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Yangzhou, Jiangsu, 225001, China
Location status: Recruiting
Dou-Sheng Bai, MD
CONTACT
Guo-Qing Jiang, MD
CONTACT
Guo-Qing Jiang, MD
SUB_INVESTIGATOR
This is a single-center, prospective, observational cohort study. The primary outcome is hepatic functional reserve(ICG-R15) at 12 and 24 months post-surgery. Secondary outcomes include peripheral blood lymphocyte subsets(CD4^+ T, CD8^+ T, Treg, NK cells), serum cytokines, and HCC recurrence rates at 12 and 24 months(confirmed by contrast-enhanced CT/MRI). All participants will undergo scheduled follow-up visits at 3, 6, 12, 18, and 24 months post-surgery. Written informed consent will be obtained from all participants before surgery. The study protocol has been approved by the Institutional Ethics Committee.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 3、6、12、18、24 months post-surgery
Comparison of changes in indocyanine green retention rate at 15 minutes (ICG-R15) from baseline to 3、6、12、18、24 months post-surgery.
Time frame: At 3, 6, 12, 18 and 24 months after surgery
Dynamic assessment of peripheral blood T cell subsets (CD4+/CD8+ ratio and absolute counts), regulatory T cells (Treg), natural killer (NK) cells, B cells, and serum cytokine profiles (IL-2, IL-6, TNF-α, IFN-γ, etc.) to evaluate postoperative immune reconstitution patterns.
Time frame: At 12 and 24 months after surgery
Intrahepatic and extrahepatic recurrence confirmed by contrast-enhanced CT or MRI, calculating the cumulative recurrence rates at 12 and 24 months after surgery.
Time frame: 12、24 months after surgery
Overall survival rate at12、 24 months after surgery, estimated by the Kaplan-Meier method.
Time frame: 12、24 months after surgery
Recurrence-free survival rate at 12、24 months after surgery, estimated by the Kaplan-Meier method.
Contact information is provided by the study sponsor or research team.
Dou-Sheng Bai, MD
CONTACT
Guo-Qing Jiang, MD
CONTACT
Northern Jiangsu People's Hospital
Other
Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function in Patients With Hepatocellular Carcinoma and Cirrhotic Hypersplenism: A Prospective Observational Cohort Study
Acronym: LHCS-HFRI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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