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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

150

Kontakter og plasseringer

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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

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:

Age 18-80 years, male or female
Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
Splenomegaly and hypersplenism
History of portal hypertension bleeding (esophageal and gastric variceal bleeding )
Child-Pugh Class A or B liver function
Ability to complete 12-month follow-up

Exclusion Criteria:

Child-Pugh Class C liver cirrhosis
Previous abdominal surgery precluding safe laparoscopic splenectomy and azygoportal disconnection
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

Studieplan

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Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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,

Samarbeidspartnere og etterforskere

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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 (Faktiske)

1. mai 2022

Primær fullføring (Faktiske)

1. mai 2025

Studiet fullført (Faktiske)

15. juli 2026

Datoer for studieregistrering

Først innsendt

3. september 2026

Først innsendt som oppfylte QC-kriteriene

9. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)