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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Total cholesterol (TC) level [Срок оценки: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
• Total triglycerides (TG) level [Срок оценки: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
• High-density lipoprotein cholesterol (HDL-C) [Срок оценки: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
• Low-density lipoprotein cholesterol (LDL-C) [Срок оценки: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]

Вторичные конечные точки (4)

• Intraoperative variables [Срок оценки: During the procedure of operation]
• Postoperative complications [Срок оценки: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
• Albumin, bilirubin [Срок оценки: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
• Child-Pugh grade [Срок оценки: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Clinical Medical College of Yangzhou University — Yangzhou

Идентификаторы

NCT: NCT07588334 · YZUC-021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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