A Prospective, Single-Center, Observational Cohort Study to Evaluate the Short-Term and Long-Term (2-Year) Effects of Laparoscopic Splenectomy on Lipid Profiles in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total cholesterol (TC) level
研究概览
简要总结
Patients with liver cirrhosis frequently exhibit dyslipidemia due to impaired hepatic lipid synthesis, altered bile acid metabolism, and portal hypertension. Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on lipid profiles over 2 years remains poorly characterized. This study will follow patients undergoing laparoscopic splenectomy to measure changes in serum lipid parameters before and after surgery, identify risk factors for lipid profile deterioration or improvement, and determine whether laparoscopic splenectomy can ameliorate dyslipidemia in the long term, thereby informing metabolic management strategies in cirrhotic patients.
详细描述
Rationale: Liver cirrhosis disrupts hepatic lipid homeostasis through multiple mechanisms, including decreased apolipoprotein synthesis, impaired cholesterol esterification, and altered very-low-density lipoprotein (VLDL) secretion, resulting in characteristic lipid abnormalities such as hypocholesterolemia and low high-density lipoprotein cholesterol (HDL-C). Hypersplenism further complicates this metabolic profile through increased lipid peroxidation and inflammatory cytokine-mediated dysregulation of lipid metabolism. Laparoscopic splenectomy (LS) reduces splenic sequestration and inflammatory burden, potentially improving hepatic lipid synthetic capacity and peripheral lipid clearance. However, perioperative stress responses, anesthetic effects, and abrupt hemodynamic changes may transiently worsen lipid profiles. Current evidence lacks prospective, 2-year data on lipid profile dynamics after LS in this population, particularly regarding the trajectory of total cholesterol, triglycerides, LDL-C, HDL-C. This study aims to fill this gap to guide perioperative metabolic monitoring and long-term dyslipidemia management.
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 lipid profile dynamics and identify risk factors for metabolic deterioration or improvement.
Study Timeline:
Months 1-6: Patient screening, enrollment, baseline lipid assessment Months 1-18: Laparoscopic splenectomy and perioperative short-term lipid monitoring Months 7-24: Long-term follow-up at 3, 6, 9,12, 24 months postoperatively Month 24: Data analysis and study completion
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, male or female
- •Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
- •Splenomegaly and hypersplenism
- •Child-Pugh Class A or B liver function
- •Signed written informed consent
- •Ability to complete 24-month follow-up
排除标准
- •Child-Pugh Class C liver cirrhosis
- •No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
- •Previous abdominal surgery precluding safe laparoscopic splenectomy.
- •Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
- •Metabolic/endocrine diseases: Familial hyperlipidemia; uncontrolled severe diabetes mellitus, thyroid dysfunction, nephrotic syndrome; use of lipid-lowering drugs, hormones, or other drugs affecting blood lipids within 1 month before surgery.
- •Infections/inflammatory diseases: Active hepatitis, severe infections, or autoimmune diseases.
- •Cirrhotic complications (hepatic encephalopathy, refractory ascites) within 1 month before surgery
- •Pregnancy or lactation
- •Poor compliance, inability to complete follow-up
结局指标
主要结局
Total cholesterol (TC) level
时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in total cholesterol (TC) level
Total triglycerides (TG) level
时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in total triglycerides (TG) level
High-density lipoprotein cholesterol (HDL-C) level
时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in high-density lipoprotein cholesterol (HDL-C)
Low-density lipoprotein cholesterol (LDL-C) level
时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in low-density lipoprotein cholesterol (LDL-C)
次要结局
- Intraoperative variables(During the procedure of operation)
- Postoperative complications(at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)
- Albumin, bilirubin(at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)
- Child-Pugh grade(at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24)
研究者
Guo-Qing Jiang
Clinical Professor
Northern Jiangsu People's Hospital