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临床试验/NCT07588334
NCT07588334尚未招募不适用

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.

Northern Jiangsu People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Total cholesterol (TC) level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Total cholesterol (TC) level

时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Change in total cholesterol (TC) level

Total triglycerides (TG) level

时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Change in total triglycerides (TG) level

High-density lipoprotein cholesterol (HDL-C)

时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

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

Low-density lipoprotein cholesterol (LDL-C)

时间窗: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

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

次要结局

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

研究者

发起方
Northern Jiangsu People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guo-Qing Jiang

Clinical Professor

Northern Jiangsu People's Hospital

研究点 (1)

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