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

10. mai 2026 oppdatert av: 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 Lipid Profiles in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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

Studietype

Observasjonsmessig

Registrering (Antatt)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Jiangsu
      • Yangzhou, Jiangsu, Kina, 225001
        • Clinical Medical College of Yangzhou University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

Inclusion Criteria:

  1. Age 18-80 years, male or female
  2. Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
  3. Splenomegaly and hypersplenism
  4. Child-Pugh Class A or B liver function
  5. Signed written informed consent
  6. Ability to complete 24-month follow-up

Exclusion Criteria:

  1. Child-Pugh Class C liver cirrhosis
  2. No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
  3. Previous abdominal surgery precluding safe laparoscopic splenectomy.
  4. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
  5. 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.
  6. Infections/inflammatory diseases: Active hepatitis, severe infections, or autoimmune diseases.
  7. Cirrhotic complications (hepatic encephalopathy, refractory ascites) within 1 month before surgery
  8. Pregnancy or lactation
  9. Poor compliance, inability to complete follow-up

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total cholesterol (TC) level
Tidsramme: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in total cholesterol (TC) level
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Total triglycerides (TG) level
Tidsramme: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in total triglycerides (TG) level
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
High-density lipoprotein cholesterol (HDL-C) level
Tidsramme: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in high-density lipoprotein cholesterol (HDL-C)
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Low-density lipoprotein cholesterol (LDL-C) level
Tidsramme: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in low-density lipoprotein cholesterol (LDL-C)
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Intraoperative variables
Tidsramme: During the procedure of operation
operation time, intraoperative blood loss, fluid infusion, mean arterial pressure
During the procedure of operation
Postoperative complications
Tidsramme: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
postoperative complications (bleeding, infection, hepatic encephalopathy, ascites)
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Albumin, bilirubin
Tidsramme: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Changes in albumin, bilirubin
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Child-Pugh grade
Tidsramme: 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.

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Northern Jiangsu People's Hospital

Etterforskere

  • Studiestol: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

28. februar 2029

Studiet fullført (Antatt)

28. februar 2029

Datoer for studieregistrering

Først innsendt

1. mai 2026

Først innsendt som oppfylte QC-kriteriene

10. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YZUC-019

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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