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RECRUITING
NCT07811687

Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function

Sponsor: Northern Jiangsu People's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-08-02

Completion Date

2029-10-20

Last Updated

2026-09-10

Healthy Volunteers

No

Locations (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, China