此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up) (LS-RF)

2026年5月14日更新者：Guo-Qing Jiang、Northern Jiangsu People's Hospital

A Prospective, Single-Center, Observational Cohort Study to Evaluate the Short-Term and Long-Term (2-Year) Effects of Laparoscopic Splenectomy on Renal Function in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism

Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether laparoscopic splenectomy can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .

研究概览

地位

尚未招聘

条件

详细说明

Rationale: Liver cirrhosis is associated with systemic hemodynamic disturbances, reduced effective circulating volume, and renal hypoperfusion, creating a high risk of renal dysfunction and hepatorenal syndrome (HRS)-a life-threatening condition reflecting the critical hepatorenal interaction. Patients with cirrhosis, splenomegaly and hypersplenism frequently have subclinical or overt renal impairment preoperatively. Laparoscopic splenectomy (LS) is a standard intervention for hypersplenism, but perioperative stress, hemodynamic fluctuations, and surgical trauma may further compromise renal function and laparoscopic splenectomy may improve the kidney function in the long term. Current evidence lacks prospective, 2-year data on renal function changes after LS in this high-risk population, especially regarding the hepatorenal axis and long-term renal outcomes. This study aims to fill this gap to guide perioperative renal protection strategies.

Study Design: Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, splenomegaly and hypersplenism scheduled for elective laparoscopic splenectomy will be enrolled and followed for 2 years to assess renal function dynamics and identify risk factors for renal injury .

Study Timeline:

Months 1-6: Patient screening, enrollment, baseline assessment
Months 1-18: Laparoscopic splenectomy and perioperative short-term renal function monitoring
Months 7-24: Long-term follow-up at 3, 6, 12, 24 months postoperatively
Month 24: Data analysis and study completion

研究类型

观察性的

注册 (估计的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Guo-Qing Jiang, MD
电话号码：+8651487373272
邮箱：jgqing2003@hotmail.com

研究联系人备份

姓名：Dou-Sheng Bai, MD
电话号码：+8651487373372
邮箱：bdsno1@hotmail.com

学习地点

中国
- Jiangsu
  - Yangzhou、Jiangsu、中国、225001
    - Clinical Medical College of Yangzhou University
    - 接触：
      
      Guo-Qing Jiang, MD
      
      电话号码：+8651487373272
      
      邮箱：jgqing2003@hotmail.com
    - 接触：
      
      Dou-Sheng Bai, MD
      
      电话号码：+8651487373372
      
      邮箱：bdsno1@hotmail.com
    - 副研究员：
      
      Guo-Qing Jiang, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不适用

取样方法

概率样本

研究人群

Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, splenomegaly and hypersplenism scheduled for elective laparoscopic splenectomy will be enrolled and followed for 2 years to assess renal function dynamics.

描述

Inclusion Criteria:

Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
Splenomegaly and hypersplenism
No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
Age 18-80 years, male or female
Child-Pugh Class A or B liver function
No history of primary renal disease or acute kidney injury (AKI)
Signed written informed consent
Ability to complete 24-month follow-up

Exclusion Criteria:

Child-Pugh Class C liver cirrhosis
Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.)
Previous abdominal surgery precluding safe laparoscopic splenectomy
Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
Cirrhotic complications (portal hypertension bleeding, hepatic encephalopathy, refractory ascites) within 1 month before surgery
Pregnancy or lactation
Poor compliance, inability to complete follow-up

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Glomerular filtration rate (eGFR) 大体时间：at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Change in estimated glomerular filtration rate (eGFR) For females: If serum creatinine (Scr) ≤ 0.7 mg/dL: eGFR = 142 × (Scr/0.7)^(-0.241) × (0.9938)^Age; If Scr > 0.7 mg/dL: eGFR = 142 × (Scr/0.7)^(-1.200) × (0.9938)^Age. For males: If Scr ≤ 0.9 mg/dL: eGFR = 142 × (Scr/0.9)^(-0.302) × (0.9938)^Age; If Scr > 0.9 mg/dL: eGFR = 142 × (Scr/0.9)^(-1.200) × (0.9938)^Age. Note: Results are in mL/min/1.73 m². Age is in years.	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Serum creatinine (Scr) level 大体时间：at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Change in serum creatinine (Scr) level	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

次要结果测量

结果测量	措施说明	大体时间
Child-Pugh grade 大体时间：at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Changes in Child-Pugh grade The Child-Pugh score is calculated based on five parameters, each assigned 1, 2, or 3 points. Total bilirubin Less than 2 mg/dL: 1 point 2-3 mg/dL: 2 points Greater than 3 mg/dL: 3 points Serum albumin Greater than 3.5 g/dL: 1 point 2.8-3.5 g/dL: 2 points Less than 2.8 g/dL: 3 points Prothrombin time prolongation or INR Prolongation less than 4 seconds (INR < 1.7): 1 point Prolongation 4-6 seconds (INR 1.7-2.3): 2 points Prolongation greater than 6 seconds (INR > 2.3): 3 points Ascites None: 1 point Mild or controlled with diuretics: 2 points Moderate to severe or refractory: 3 points Hepatic encephalopathy None: 1 point Grade I-II: 2 points Grade III-IV: 3 points Total score and corresponding grade 5-6 points: Child-Pugh class A 7-9 points: Child-Pugh class B 10-15 points: Child-Pugh class C	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Urine albumin-to-creatinine ratio (UACR) 大体时间：at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Changes in Urine albumin-to-creatinine ratio [UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)]	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Postoperative complications 大体时间：at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24	bleeding, infection, hepatic encephalopathy, ascites	at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24
BUN and UA level 大体时间：at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Changes in BUN and UA level	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Intraoperative variables 大体时间：During the procedure of operation	operation time, intraoperative blood loss, fluid infusion	During the procedure of operation
Albumin and bilirubin level 大体时间：at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Changes in Albumin and bilirubin level	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Northern Jiangsu People's Hospital

调查人员

学习椅：Guo-Qing Jiang, MD、Clinical Medical College of Yangzhou University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2029年2月28日

研究完成 (估计的)

2029年2月28日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年5月10日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年5月18日

上次提交的符合 QC 标准的更新