Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001, China
NCT Number: NCT07588373
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Yangzhou, Jiangsu, 225001, China
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in total cholesterol (TC) level
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in total triglycerides (TG) level
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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
Change in low-density lipoprotein cholesterol (LDL-C)
Time frame: During the procedure of operation
operation time, intraoperative blood loss, fluid infusion, mean arterial pressure
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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
Changes in albumin, bilirubin
Time frame: 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 score and corresponding grade
Contact information is provided by the study sponsor or research team.
Dou-Sheng Bai, MD
CONTACT
Guo-Qing Jiang, MD
CONTACT
Northern Jiangsu People's Hospital
Other
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
Acronym: LS-LP-CH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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