Effect of LSD on Lipid Profiles in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNorthern Jiangsu People's Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Total cholesterol (TC) level

Change in total cholesterol (TC) level

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
2

Total triglycerides (TG) level

Change in total triglycerides (TG) level

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
3

High-density lipoprotein cholesterol (HDL-C)

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

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
4

Low-density lipoprotein cholesterol (LDL-C)

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

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Secondary outcomes

1

Intraoperative variables

operation time, intraoperative blood loss, fluid infusion, mean arterial pressure,

Time frame
During the procedure of operation
2

Postoperative complications

bleeding, infection, hepatic encephalopathy, ascites

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
3

Albumin, bilirubin

Changes in Child-Pugh grade, albumin, bilirubin

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
4

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

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Other outcomes

Sponsors and contacts

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