Effect of Laparoscopic Splenectomy on Lipid Profiles in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up) (LS-LP-CH)
A Prospective, Single-Center, Observational Cohort Study to Evaluate the Short-Term and Long-Term (2-Year) Effects of Laparoscopic Splenectomy on Lipid Profiles in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism
연구 개요
상세 설명
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). Hypersplenism further complicates this metabolic profile through increased lipid peroxidation and inflammatory cytokine-mediated dysregulation of lipid metabolism. Laparoscopic splenectomy (LS) reduces splenic sequestration and inflammatory burden, potentially improving hepatic lipid synthetic capacity and peripheral lipid clearance. However, perioperative stress responses, anesthetic effects, and abrupt hemodynamic changes may transiently worsen lipid profiles. Current evidence lacks prospective, 2-year data on lipid profile dynamics after LS in this population, particularly regarding the trajectory of total cholesterol, triglycerides, LDL-C, HDL-C. This study aims to fill this gap to guide perioperative metabolic monitoring and long-term dyslipidemia management.
Study Design: Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, splenomegaly and hypersplenism scheduled for elective laparoscopic splenectomy 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 perioperative short-term lipid monitoring Months 7-24: Long-term follow-up at 3, 6, 9,12, 24 months postoperatively Month 24: Data analysis and study completion
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Guo-Qing Jiang, MD
- 전화번호: +8651487373272
- 이메일: jgqing2003@hotmail.com
연구 연락처 백업
- 이름: Dou-Sheng Bai, MD
- 전화번호: +8651487373372
- 이메일: bdsno1@hotmail.com
연구 장소
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Jiangsu
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Yangzhou, Jiangsu, 중국, 225001
- Clinical Medical College of Yangzhou University
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참여기준
자격 기준
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- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 18-80 years, male or female
- Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
- Splenomegaly and hypersplenism
- 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
- No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
- Previous abdominal surgery precluding safe laparoscopic splenectomy.
- 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
공부 계획
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디자인 세부사항
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주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total cholesterol (TC) level
기간: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Change in total cholesterol (TC) level
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Total triglycerides (TG) level
기간: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Change in total triglycerides (TG) level
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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High-density lipoprotein cholesterol (HDL-C) level
기간: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Change in high-density lipoprotein cholesterol (HDL-C)
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Low-density lipoprotein cholesterol (LDL-C) level
기간: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Change in low-density lipoprotein cholesterol (LDL-C)
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intraoperative variables
기간: During the procedure of operation
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operation time, intraoperative blood loss, fluid infusion, mean arterial pressure
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During the procedure of operation
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Postoperative complications
기간: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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postoperative complications (bleeding, infection, hepatic encephalopathy, ascites)
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Albumin, bilirubin
기간: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Changes in albumin, bilirubin
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Child-Pugh grade
기간: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Changes in Child-Pugh grade The Child-Pugh score is calculated based on five parameters, each assigned 1, 2, or 3 points.
Total score and corresponding grade
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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공동 작업자 및 조사자
수사관
- 연구 의자: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University
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