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
Descripción general del estudio
Estado
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Guo-Qing Jiang, MD
- Número de teléfono: +8651487373272
- Correo electrónico: jgqing2003@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Dou-Sheng Bai, MD
- Número de teléfono: +8651487373372
- Correo electrónico: bdsno1@hotmail.com
Ubicaciones de estudio
-
-
Jiangsu
-
Yangzhou, Jiangsu, Porcelana, 225001
- Clinical Medical College of Yangzhou University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total cholesterol (TC) level
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
Change in total cholesterol (TC) level
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
|
Total triglycerides (TG) level
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
Change in total triglycerides (TG) level
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
|
High-density lipoprotein cholesterol (HDL-C) level
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
Change in high-density lipoprotein cholesterol (HDL-C)
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
|
Low-density lipoprotein cholesterol (LDL-C) level
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
Change in low-density lipoprotein cholesterol (LDL-C)
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intraoperative variables
Periodo de tiempo: During the procedure of operation
|
operation time, intraoperative blood loss, fluid infusion, mean arterial pressure
|
During the procedure of operation
|
|
Postoperative complications
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
postoperative complications (bleeding, infection, hepatic encephalopathy, ascites)
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
|
Albumin, bilirubin
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
Changes in albumin, bilirubin
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
|
Child-Pugh grade
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
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
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- YZUC-019
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .