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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

150

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Total triglycerides (TG) level Tidsram: 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 Tidsram: 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) Tidsram: 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) Tidsram: 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,

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
albumin, bilirubin Tidsram: 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 Tidsram: 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,

Samarbetspartners och utredare

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Sponsor

Northern Jiangsu People's Hospital

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2022

Primärt slutförande (Faktisk)

1 maj 2025

Avslutad studie (Faktisk)

15 juli 2026

Studieregistreringsdatum

Först inskickad

3 september 2026

Först inskickad som uppfyllde QC-kriterierna

9 september 2026

Första postat (Faktisk)

10 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)