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Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function (LHCS-HFRI)

9 de setembro de 2026 atualizado por: Guo-Qing Jiang, Northern Jiangsu People's Hospital

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

Contactos e Locais

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Contato de estudo

Nome: Guo-Qing Jiang, MD
Número de telefone: +8651487373272
E-mail: jgqing2003@hotmail.com

Estude backup de contato

Nome: Dou-Sheng Bai, MD
E-mail: bdsno1@hotmail.com

Locais de estudo

China
- Jiangsu
  - Yangzhou, Jiangsu, China, 225001
    - Recrutamento
    - Clinical Medical College of Yangzhou University
    - Contato:
      
      Guo-Qing Jiang, MD
      
      Número de telefone: +8651487373272
      
      E-mail: jgqing2003@hotmail.com
    - Contato:
      
      Dou-Sheng Bai, MD
      
      E-mail: bdsno1@hotmail.com
    - Subinvestigador:
      
      Guo-Qing Jiang, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra de Probabilidade

População do estudo

This is a 2-year prospective, single-center, observational cohort study. Patients diagnosed with hepatocellular carcinoma (HCC) complicated with cirrhotic hypersplenism, who are scheduled to undergo elective laparoscopic hepatectomy combined with splenectomy, will be enrolled and followed for 2 years to evaluate the dynamic changes in hepatic functional reserve (assessed by ICG-R15, Child-Pugh score, and ALBI grade) and immune function (peripheral blood lymphocyte subsets including CD4⁺/CD8⁺ T cells, Tregs, NK cells, B cells, and serum cytokine profiles). Assessments will be performed at baseline and at 3, 6, 12, 18, and 24 months post-surgery.

Descrição

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

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change in Hepatic Functional Reserve (ICG-R15) Prazo: 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.	Baseline, 3、6、12、18、24 months post-surgery

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Dynamic Changes of Peripheral Blood Lymphocyte Subsets and Cytokines Prazo: 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.	At 3, 6, 12, 18 and 24 months after surgery
Hepatocellular Carcinoma (HCC) Recurrence Rate Prazo: 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.	At 12 and 24 months after surgery
Overall Survival (OS) Prazo: 12、24 months after surgery	Overall survival rate at12、 24 months after surgery, estimated by the Kaplan-Meier method.	12、24 months after surgery
Recurrence-Free Survival (RFS) Prazo: 12、24 months after surgery	Recurrence-free survival rate at 12、24 months after surgery, estimated by the Kaplan-Meier method.	12、24 months after surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Northern Jiangsu People's Hospital

Investigadores

Cadeira de estudo: Guo-Qing Jiang, Clinical Medical College of Yangzhou University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de agosto de 2026

Conclusão Primária (Estimado)

20 de julho de 2029

Conclusão do estudo (Estimado)

20 de outubro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

3 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de setembro de 2026

Primeira postagem (Real)

10 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)