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NCT Number: NCT07588373

Effect of Laparoscopic Splenectomy on Lipid Profiles in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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 cholesterol (TC) level

  2. Total triglycerides (TG) 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

  3. High-density lipoprotein cholesterol (HDL-C) 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)

  4. Low-density lipoprotein cholesterol (LDL-C) level

    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)

Secondary outcomes

  1. Intraoperative variables

    Time frame: During the procedure of operation

    operation time, intraoperative blood loss, fluid infusion, mean arterial pressure

  2. Postoperative complications

    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)

  3. Albumin, bilirubin

    Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

    Changes in albumin, bilirubin

  4. Child-Pugh grade

    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 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dou-Sheng Bai, MD

CONTACT

[email protected]

+8651487373372

Guo-Qing Jiang, MD

CONTACT

[email protected]

+8651487373272

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 14, 2026
Registry last updated
May 14, 2026

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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