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

September 9, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Guo-Qing Jiang, MD
Phone Number: +8651487373272
Email: jgqing2003@hotmail.com

Study Contact Backup

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

Study Locations

China
- Jiangsu
  - Yangzhou, Jiangsu, China, 225001
    - Recruiting
    - Clinical Medical College of Yangzhou University
    - Contact:
      
      Guo-Qing Jiang, MD
      
      Phone Number: +8651487373272
      
      Email: jgqing2003@hotmail.com
    - Contact:
      
      Dou-Sheng Bai, MD
      
      Email: bdsno1@hotmail.com
    - Sub-Investigator:
      
      Guo-Qing Jiang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 3、6、12、18、24 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3, 6, 12, 18 and 24 months after surgery
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.	At 12 and 24 months after surgery
Overall Survival (OS) Time Frame: 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) Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Jiangsu People's Hospital

Investigators

Study Chair: Guo-Qing Jiang, Clinical Medical College of Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2026

Primary Completion (Estimated)

July 20, 2029

Study Completion (Estimated)

October 20, 2029

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)