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Effect of LSD on Lipid Profiles Within 1 Year Postoperatively in Cirrhosis Patients With Portal Hypertension Bleeding (LSD-LPPH)

9. september 2026 opdateret af: Guo-Qing Jiang, Northern Jiangsu People's Hospital

Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Lipid Profiles Within 1 Year Postoperatively n Cirrhosis Patients With Portal Hypertension Bleeding

Patients with liver cirrhosis frequently exhibit dyslipidemia due to impaired hepatic lipid synthesis, altered bile acid metabolism, and portal hypertension. Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) is commonly used to treat Cirrhosis with Portal Hypertension Bleeding in these patients, but its impact on lipid profiles within 1 year postoperatively remains poorly characterized. This study will follow patients undergoing LSD to measure changes in serum lipid parameters before and after surgery, identify risk factors for lipid profile deterioration or improvement, and determine whether LSD can ameliorate dyslipidemia in the long term, thereby informing metabolic management strategies in cirrhotic patients.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This study is a single-center retrospective medical record analysis. Patients who had undergone laparoscopic splenectomy and azygoportal disconnection were screened and included in medical records. Preoperative baseline data, as well as laboratory and clinical data at 3, 6, 9, and 12 months postoperatively, were extracted from the medical records to analyze the dynamic trends of four serum lipid parameters (total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol). Intraoperative indicators, postoperative complications, albumin, bilirubin, and changes in Child-Pugh liver function classification were also collected as secondary outcome measures for statistical analysis.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Retrospective, single-center, observational cohort study. Medical records of patients with cirrhosis, splenomegaly and hypersplenism, and portal hypertension bleeding who had undergone Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) were reviewed. Preoperative baseline data and postoperative data at 3, 6, 9, and 12 months were extracted to evaluate dynamic changes in lipid profiles within 1 year postoperatively.

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. History of portal hypertension bleeding (esophageal and gastric variceal bleeding )
  5. Child-Pugh Class A or B liver function
  6. Ability to complete 12-month follow-up

Exclusion Criteria:

  1. Child-Pugh Class C liver cirrhosis
  2. Previous abdominal surgery precluding safe laparoscopic splenectomy and azygoportal disconnection
  3. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
  4. 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.
  5. Infections/inflammatory diseases: Active hepatitis, severe infections, or autoimmune diseases.
  6. Cirrhotic complications (hepatic encephalopathy, refractory ascites) within 1 month before surgery
  7. Pregnancy or lactation
  8. Poor compliance, inability to complete follow-up

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total triglycerides (TG) level
Tidsramme: baseline, postoperative month 3, month 6, month 9, month 12,
Change in total triglycerides (TG) level
baseline, postoperative month 3, month 6, month 9, month 12,
Total cholesterol (TC) leve
Tidsramme: baseline, and postoperative month 3, month 6, month 9,month 12
Change in total cholesterol (TC) level
baseline, and postoperative month 3, month 6, month 9,month 12
High-density lipoprotein cholesterol (HDL-C)
Tidsramme: baseline, and postoperative month 3, month 6, month 9,month 12,
Change in high-density lipoprotein cholesterol (HDL-C) level
baseline, and postoperative month 3, month 6, month 9,month 12,
Low-density lipoprotein cholesterol (LDL-C)
Tidsramme: baseline, and postoperative month 3, month 6, month 9, month 12,
Change in low-density lipoprotein cholesterol (LDL-C) level
baseline, and postoperative month 3, month 6, month 9, month 12,

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
albumin, bilirubin
Tidsramme: baseline, and postoperative month 3, month 6, month 9, month 12,
albumin, bilirubin level
baseline, and postoperative month 3, month 6, month 9, month 12,
Child-Pugh grade
Tidsramme: baseline, and postoperative month 3, month 6, month 9,month 12,
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
baseline, and postoperative month 3, month 6, month 9,month 12,

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northern Jiangsu People's Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2022

Primær færdiggørelse (Faktiske)

1. maj 2025

Studieafslutning (Faktiske)

15. juli 2026

Datoer for studieregistrering

Først indsendt

3. september 2026

Først indsendt, der opfyldte QC-kriterier

9. september 2026

Først opslået (Faktiske)

10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • YZUC-024

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