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

9 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Guo-Qing Jiang, MD
Numero di telefono: +8651487373272
Email: jgqing2003@hotmail.com

Backup dei contatti dello studio

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

Luoghi di studio

Cina
- Jiangsu
  - Yangzhou, Jiangsu, Cina, 225001
    - Reclutamento
    - Clinical Medical College of Yangzhou University
    - Contatto:
      
      Guo-Qing Jiang, MD
      
      Numero di telefono: +8651487373272
      
      Email: jgqing2003@hotmail.com
    - Contatto:
      
      Dou-Sheng Bai, MD
      
      Email: bdsno1@hotmail.com
    - Sub-investigatore:
      
      Guo-Qing Jiang, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Adulto
Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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

Piano di studio

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Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change in Hepatic Functional Reserve (ICG-R15) Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Dynamic Changes of Peripheral Blood Lymphocyte Subsets and Cytokines Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Northern Jiangsu People's Hospital

Investigatori

Cattedra di studio: Guo-Qing Jiang, Clinical Medical College of Yangzhou University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 agosto 2026

Completamento primario (Stimato)

20 luglio 2029

Completamento dello studio (Stimato)

20 ottobre 2029

Date di iscrizione allo studio

Primo inviato

3 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)