About this trial
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 over 2 years 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 )
Disqualifiers
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.
Trial population
Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, Splenomegaly and hypersplenism, Portal Hypertension Bleeding scheduled for Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) will be enrolled and followed for 2 years to evaluate dynamic changes in lipid profiles.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Total cholesterol (TC) level
Change in total cholesterol (TC) level
Total triglycerides (TG) level
Change in total triglycerides (TG) level
High-density lipoprotein cholesterol (HDL-C)
Change in high-density lipoprotein cholesterol (HDL-C) level
Low-density lipoprotein cholesterol (LDL-C)
Change in low-density lipoprotein cholesterol (LDL-C) level
Secondary outcomes
Intraoperative variables
operation time, intraoperative blood loss, fluid infusion, mean arterial pressure,
Postoperative complications
bleeding, infection, hepatic encephalopathy, ascites
Albumin, bilirubin
Changes in Child-Pugh grade, albumin, bilirubin
Child-Pugh grade
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 contacts
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