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
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Guo-Qing Jiang, MD
- 電話番号：+8651487373272
- メール：jgqing2003@hotmail.com
研究連絡先のバックアップ
- 名前：Dou-Sheng Bai, MD
- 電話番号：+8651487373372
- メール：bdsno1@hotmail.com
研究場所
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Jiangsu
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Yangzhou、Jiangsu、中国、225001
- Clinical Medical College of Yangzhou University
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total cholesterol (TC) level
時間枠：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
時間枠：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
時間枠：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
|
|
Low-density lipoprotein cholesterol (LDL-C) level
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intraoperative variables
時間枠：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
時間枠：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
時間枠：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
|
|
Child-Pugh grade
時間枠：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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協力者と研究者
捜査官
- スタディチェア：Guo-Qing Jiang, MD、Clinical Medical College of Yangzhou University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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