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NCT Number: NCT07811687

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location status: Recruiting

Location contact

Dou-Sheng Bai, MD

CONTACT

[email protected]

Guo-Qing Jiang, MD

CONTACT

[email protected]

+8651487373272

Guo-Qing Jiang, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years, both male and female.
  • Hepatocellular carcinoma (HCC) confirmed by clinical, pathological, and radiological examinations, meeting either of the following criteria:Solitary tumor with maximum diameter ≤ 5 cm; or Multiple tumors (≤ 3 in number), each with maximum diameter ≤ 3 cm.
  • Liver cirrhosis with splenomegaly and hypersplenism, and preoperative platelet count (Plt) < 80 × 10⁹/L.
  • Liver function Child-Pugh class A or B, with ICG-R15 test indicating tolerance for the planned surgical resection.
  • Voluntarily sign written informed consent.
  • Able to complete 24-month follow-up.

Exclusion criteria

  • Imaging evidence of extrahepatic metastasis or major vascular invasion (portal vein, hepatic vein); or concurrent other malignancy within the past 5 years.
  • End-stage liver cirrhosis (Child-Pugh class C).
  • Prior history of hepatectomy or splenectomy; or prior other abdominal surgery that precludes safe performance of laparoscopic hepatectomy combined with splenectomy.
  • Cirrhosis-related complications (hepatic encephalopathy, refractory ascites) occurring within 1 month before surgery.
  • Severe cardiac, pulmonary, or cerebrovascular dysfunction.
  • Active infection or underlying disease requiring immunosuppressive therapy.
  • Pregnancy or lactation.
  • Poor compliance, unable to complete the scheduled follow-up

Treatment and study plan

Primary outcomes

  1. Change in Hepatic Functional Reserve (ICG-R15)

    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.

Secondary outcomes

  1. Dynamic Changes of Peripheral Blood Lymphocyte Subsets and Cytokines

    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.

  2. Hepatocellular Carcinoma (HCC) Recurrence Rate

    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.

  3. Overall Survival (OS)

    Time frame: 12、24 months after surgery

    Overall survival rate at12、 24 months after surgery, estimated by the Kaplan-Meier method.

  4. Recurrence-Free Survival (RFS)

    Time frame: 12、24 months after surgery

    Recurrence-free survival rate at 12、24 months after surgery, estimated by the Kaplan-Meier method.

Study contacts

Contact information is provided by the study sponsor or research team.

Dou-Sheng Bai, MD

CONTACT

[email protected]

Guo-Qing Jiang, MD

CONTACT

[email protected]

+8651487373272

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study 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

Acronym: LHCS-HFRI

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

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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