Effect of LSD on Lipid Profiles Within 1 Year Postoperatively in Cirrhosis Patients With Portal Hypertension Bleeding (LSD-LPPH)
2026年9月9日 更新者:Guo-Qing Jiang、Northern Jiangsu People's Hospital
Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Lipid Profiles Within 1 Year Postoperatively n Cirrhosis Patients With Portal Hypertension Bleeding
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 within 1 year postoperatively 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.
研究概览
详细说明
This study is a single-center retrospective medical record analysis.
Patients who had undergone laparoscopic splenectomy and azygoportal disconnection were screened and included in medical records.
Preoperative baseline data, as well as laboratory and clinical data at 3, 6, 9, and 12 months postoperatively, were extracted from the medical records to analyze the dynamic trends of four serum lipid parameters (total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol).
Intraoperative indicators, postoperative complications, albumin, bilirubin, and changes in Child-Pugh liver function classification were also collected as secondary outcome measures for statistical analysis.
研究类型
观察性的
注册 (实际的)
150
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Jiangsu
-
Yangzhou、Jiangsu、中国、225001
- Clinical Medical College of Yangzhou University
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
Retrospective, single-center, observational cohort study.
Medical records of patients with cirrhosis, splenomegaly and hypersplenism, and portal hypertension bleeding who had undergone Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) were reviewed.
Preoperative baseline data and postoperative data at 3, 6, 9, and 12 months were extracted to evaluate dynamic changes in lipid profiles within 1 year postoperatively.
描述
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
- Ability to complete 12-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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total triglycerides (TG) level
大体时间:baseline, postoperative month 3, month 6, month 9, month 12,
|
Change in total triglycerides (TG) level
|
baseline, postoperative month 3, month 6, month 9, month 12,
|
|
Total cholesterol (TC) leve
大体时间:baseline, and postoperative month 3, month 6, month 9,month 12
|
Change in total cholesterol (TC) level
|
baseline, and postoperative month 3, month 6, month 9,month 12
|
|
High-density lipoprotein cholesterol (HDL-C)
大体时间:baseline, and postoperative month 3, month 6, month 9,month 12,
|
Change in high-density lipoprotein cholesterol (HDL-C) level
|
baseline, and postoperative month 3, month 6, month 9,month 12,
|
|
Low-density lipoprotein cholesterol (LDL-C)
大体时间:baseline, and postoperative month 3, month 6, month 9, month 12,
|
Change in low-density lipoprotein cholesterol (LDL-C) level
|
baseline, and postoperative month 3, month 6, month 9, month 12,
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
albumin, bilirubin
大体时间:baseline, and postoperative month 3, month 6, month 9, month 12,
|
albumin, bilirubin level
|
baseline, and postoperative month 3, month 6, month 9, month 12,
|
|
Child-Pugh grade
大体时间:baseline, and postoperative month 3, month 6, month 9,month 12,
|
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
|
baseline, and postoperative month 3, month 6, month 9,month 12,
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Guo-Qing Jiang, MD、Clinical Medical College of Yangzhou University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年5月1日
初级完成 (实际的)
2025年5月1日
研究完成 (实际的)
2026年7月15日
研究注册日期
首次提交
2026年9月3日
首先提交符合 QC 标准的
2026年9月9日
首次发布 (实际的)
2026年9月10日
研究记录更新
最后更新发布 (实际的)
2026年9月10日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- YZUC-024
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不
研究美国 FDA 监管的设备产品
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