Effect of LSD on Lipid Profiles in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver, Splenectomy; Status, Portal Hypertension, Lipid Profiles. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Single-Center, Observational Cohort Study to Evaluate the Long-Term (2-Year) Effects of Laparoscopic Splenectomy and Azygoportal Disconnection on Lipid Profiles in Patients With Liver Cirrhosis, Portal Hypertension Bleeding.
Overview
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.
Detailed description
Rationale: Liver cirrhosis disrupts hepatic lipid homeostasis through multiple mechanisms, including decreased apolipoprotein synthesis, impaired cholesterol esterification, and altered very-low-density lipoprotein (VLDL) secretion, resulting in characteristic lipid abnormalities such as hypocholesterolemia and low high-density lipoprotein cholesterol (HDL-C). Laparoscopic splenectomy combined with azygoportal disconnection (LSD) is commonly used to treat 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 Cirrhosis with Portal Hypertension Bleeding in these patients.Study Design: Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with Cirrhosis with Portal Hypertension Bleeding scheduled for elective LSD will be enrolled and followed for 2 years to assess lipid profile dynamics and identify risk factors for metabolic deterioration or improvement. Study Timeline:Months 1-6: Patient screening, enrollment, baseline lipid assessment Months 1-18: Laparoscopic Splenectomy and Azygoportal Disconnection and perioperative short-term lipid monitoring Months 7-24: Long-term follow-up at 3, 6, 9,12, 24 months postoperativelyMonth 24: Data analysis and study completion.
Primary outcome measures
- Total cholesterol (TC) level [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Total triglycerides (TG) level [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- High-density lipoprotein cholesterol (HDL-C) [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Low-density lipoprotein cholesterol (LDL-C) [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
Secondary outcome measures (4)
- Intraoperative variables [Time frame: During the procedure of operation]
- Postoperative complications [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Albumin, bilirubin [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Child-Pugh grade [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
Eligibility criteria
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
- Signed written informed consent
- Ability to complete 24-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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Clinical Medical College of Yangzhou University — Yangzhou
Identifiers
NCT: NCT07588334 · YZUC-021