An observational study in Cirrhosis, Splenectomy; Status and Hypersplenism, sponsored by Northern Jiangsu People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Northern Jiangsu People's Hospital · Observational
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.
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
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A 24-month (2-year) prospective, single-center, observational cohort study. Patients with liver cirrhosis and hypersplenism scheduled for elective laparoscopic splenectomy will be recruited and followed up for 2 years to evaluate dynamic changes in lipid profiles.
Exclusion Criteria:
Total cholesterol (TC) level
Change in total cholesterol (TC) level
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Total triglycerides (TG) level
Change in total triglycerides (TG) level
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
High-density lipoprotein cholesterol (HDL-C) level
Change in high-density lipoprotein cholesterol (HDL-C)
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Low-density lipoprotein cholesterol (LDL-C) level
Change in low-density lipoprotein cholesterol (LDL-C)
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Intraoperative variables
operation time, intraoperative blood loss, fluid infusion, mean arterial pressure
Time frame: During the procedure of operation
Postoperative complications
postoperative complications (bleeding, infection, hepatic encephalopathy, ascites)
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Albumin, bilirubin
Changes in albumin, bilirubin
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Child-Pugh grade
Changes in Child-Pugh grade The Child-Pugh score is calculated based on five parameters, each assigned 1, 2, or 3 points. 1. Total bilirubin * Less than 2 mg/dL: 1 point * 2-3 mg/dL: 2 points * Greater than 3 mg/dL: 3 points 2. 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 3. 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 4. Ascites * None: 1 point * Mild or controlled with diuretics: 2 points * Moderate to severe or refractory: 3 points 5. 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
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Northern Jiangsu People's Hospital