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Completed

NCT Number: NCT07811700

Effect of LSD on Lipid Profiles Within 1 Year Postoperatively in 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.

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Key information

Conditions

Lipid Profiles Cirrhosis, Liver Digestive System Diseases Fibrosis Hemic and Lymphatic Diseases Hypersplenism Hypertension, Portal Liver Cirrhosis Liver Diseases Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Splenectomy; Status Splenic Diseases

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

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.

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
  • 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

Treatment and study plan

Primary outcomes

  1. Total triglycerides (TG) level

    Time frame: baseline, postoperative month 3, month 6, month 9, month 12,

    Change in total triglycerides (TG) level

  2. Total cholesterol (TC) leve

    Time frame: baseline, and postoperative month 3, month 6, month 9,month 12

    Change in total cholesterol (TC) level

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

    Time frame: baseline, and postoperative month 3, month 6, month 9,month 12,

    Change in high-density lipoprotein cholesterol (HDL-C) level

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

    Time frame: baseline, and postoperative month 3, month 6, month 9, month 12,

    Change in low-density lipoprotein cholesterol (LDL-C) level

Secondary outcomes

  1. albumin, bilirubin

    Time frame: baseline, and postoperative month 3, month 6, month 9, month 12,

    albumin, bilirubin level

  2. Child-Pugh grade

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

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

Acronym: LSD-LPPH

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 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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