Liver CirrhosisLHCS-HFRINCT07811687
Effect of Laparoscopic Hepatectomy Combined With Splenectomy on Hepatic Functional Reserve and Immune Function
An observational study of Liver Cirrhosis and HCC - Hepatocellular Carcinoma, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, HCC - Hepatocellular Carcinoma, Hypersplenism
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2026to 20 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dou-Sheng Bai, MD contact
China1 site, 1 recruiting
- Recruiting
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001
Guo-Qing Jiang, MD, +8651487373272, jgqing2003@hotmail.com
Dou-Sheng Bai, MD, bdsno1@hotmail.com
About this study
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
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.
Read the 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.
- Keywords
- Laparoscopic Hepatectomy, Laparoscopic Splenectomy, Hepatic Functional Reserve, Hepatic Immune Function, Hepatocellular Carcinoma, Cirrhotic Hypersplenism
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Hypersplenism
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hepatic Functional Reserve (ICG-R15)
Comparison of changes in indocyanine green retention rate at 15 minutes (ICG-R15) from baseline to 3、6、12、18、24 months post-surgery.
Measured: Baseline, 3、6、12、18、24 months post-surgery
Secondary outcomes (4)
Dynamic Changes of Peripheral Blood Lymphocyte Subsets and Cytokines
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.
Measured: At 3, 6, 12, 18 and 24 months after surgery
Hepatocellular Carcinoma (HCC) Recurrence Rate
Intrahepatic and extrahepatic recurrence confirmed by contrast-enhanced CT or MRI, calculating the cumulative recurrence rates at 12 and 24 months after surgery.
Measured: At 12 and 24 months after surgery
Overall Survival (OS)
Overall survival rate at12、 24 months after surgery, estimated by the Kaplan-Meier method.
Measured: 12、24 months after surgery
Recurrence-Free Survival (RFS)
Recurrence-free survival rate at 12、24 months after surgery, estimated by the Kaplan-Meier method.
Measured: 12、24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start2 Aug 2026
- Primary completion20 Jul 2029 (estimated)
- Study completion20 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
- Investigators
- Guo-Qing Jiang, Study chair, Clinical Medical College of Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811687
- Sponsor's protocol ID
- YZUC-023
- Acronym
- LHCS-HFRI
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07811687
- Acronym / sponsor ID
- LHCS-HFRI / YZUC-023
- Keywords
- Laparoscopic Hepatectomy, Laparoscopic Splenectomy, Hepatic Functional Reserve, Hepatic Immune Function, Hepatocellular Carcinoma, Cirrhotic Hypersplenism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 2 Aug 2026 (actual)
- Primary completion
- 20 Jul 2029 (estimated)
- Study completion
- 20 Oct 2029 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Dynamic Changes of Peripheral Blood Lymphocyte Subsets and Cytokines
Time frame: At 3, 6, 12, 18 and 24 months after surgery
Hepatocellular Carcinoma (HCC) Recurrence Rate
Time frame: At 12 and 24 months after surgery
Overall Survival (OS)
Time frame: 12、24 months after surgery
Recurrence-Free Survival (RFS)
Time frame: 12、24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dou-Sheng Bai, MD contact
Guo-Qing Jiang study chair
Clinical Medical College of Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and HCC - Hepatocellular Carcinoma, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo-Qing Jiang, MD (+8651487373272, jgqing2003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hepatic Functional Reserve (ICG-R15) (time frame: Baseline, 3、6、12、18、24 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.