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

2026년 9월 9일 업데이트: 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.

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Guo-Qing Jiang, MD
전화번호: +8651487373272
이메일: jgqing2003@hotmail.com

연구 연락처 백업

이름: Dou-Sheng Bai, MD
이메일: bdsno1@hotmail.com

연구 장소

중국
- Jiangsu
  - Yangzhou, Jiangsu, 중국, 225001
    - 모병
    - Clinical Medical College of Yangzhou University
    - 연락하다:
      
      Guo-Qing Jiang, MD
      
      전화번호: +8651487373272
      
      이메일: jgqing2003@hotmail.com
    - 연락하다:
      
      Dou-Sheng Bai, MD
      
      이메일: bdsno1@hotmail.com
    - 부수사관:
      
      Guo-Qing Jiang, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

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아니

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연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

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주요 결과 측정

결과 측정	측정값 설명	기간
Change in Hepatic Functional Reserve (ICG-R15) 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Dynamic Changes of Peripheral Blood Lymphocyte Subsets and Cytokines 기간: 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 기간: 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) 기간: 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) 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Northern Jiangsu People's Hospital

수사관

연구 의자: Guo-Qing Jiang, Clinical Medical College of Yangzhou University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 2일

기본 완료 (추정된)

2029년 7월 20일

연구 완료 (추정된)

2029년 10월 20일

연구 등록 날짜

최초 제출

2026년 9월 3일

QC 기준을 충족하는 최초 제출

2026년 9월 9일

처음 게시됨 (실제)

2026년 9월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)