Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up) (LS-RF)
A Prospective, Single-Center, Observational Cohort Study to Evaluate the Short-Term and Long-Term (2-Year) Effects of Laparoscopic Splenectomy on Renal Function in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism
Descripción general del estudio
Estado
Descripción detallada
Rationale: Liver cirrhosis is associated with systemic hemodynamic disturbances, reduced effective circulating volume, and renal hypoperfusion, creating a high risk of renal dysfunction and hepatorenal syndrome (HRS)-a life-threatening condition reflecting the critical hepatorenal interaction. Patients with cirrhosis, splenomegaly and hypersplenism frequently have subclinical or overt renal impairment preoperatively. Laparoscopic splenectomy (LS) is a standard intervention for hypersplenism, but perioperative stress, hemodynamic fluctuations, and surgical trauma may further compromise renal function and laparoscopic splenectomy may improve the kidney function in the long term. Current evidence lacks prospective, 2-year data on renal function changes after LS in this high-risk population, especially regarding the hepatorenal axis and long-term renal outcomes. This study aims to fill this gap to guide perioperative renal protection strategies.
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 renal function dynamics and identify risk factors for renal injury .
Study Timeline:
- Months 1-6: Patient screening, enrollment, baseline assessment
- Months 1-18: Laparoscopic splenectomy and perioperative short-term renal function monitoring
- Months 7-24: Long-term follow-up at 3, 6, 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
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Jiangsu
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Yangzhou, Jiangsu, Porcelana, 225001
- Clinical Medical College of Yangzhou University
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Contacto:
- Guo-Qing Jiang, MD
- Número de teléfono: +8651487373272
- Correo electrónico: jgqing2003@hotmail.com
-
Contacto:
- Dou-Sheng Bai, MD
- Número de teléfono: +8651487373372
- Correo electrónico: bdsno1@hotmail.com
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Sub-Investigador:
- Guo-Qing Jiang, MD
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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:
- Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
- Splenomegaly and hypersplenism
- No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
- Age 18-80 years, male or female
- Child-Pugh Class A or B liver function
- No history of primary renal disease or acute kidney injury (AKI)
- Signed written informed consent
- Ability to complete 24-month follow-up
Exclusion Criteria:
- Child-Pugh Class C liver cirrhosis
- Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.)
- Previous abdominal surgery precluding safe laparoscopic splenectomy
- Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
- Cirrhotic complications (portal hypertension bleeding, 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 |
|---|---|---|
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Glomerular filtration rate (eGFR)
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Change in estimated glomerular filtration rate (eGFR) For females: If serum creatinine (Scr) ≤ 0.7 mg/dL: eGFR = 142 × (Scr/0.7)^(-0.241) × (0.9938)^Age; If Scr > 0.7 mg/dL: eGFR = 142 × (Scr/0.7)^(-1.200) × (0.9938)^Age. For males: If Scr ≤ 0.9 mg/dL: eGFR = 142 × (Scr/0.9)^(-0.302) × (0.9938)^Age; If Scr > 0.9 mg/dL: eGFR = 142 × (Scr/0.9)^(-1.200) × (0.9938)^Age. Note: Results are in mL/min/1.73 m². Age is in years. |
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Serum creatinine (Scr) level
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Change in serum creatinine (Scr) 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Child-Pugh grade
Periodo de tiempo: 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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Urine albumin-to-creatinine ratio (UACR)
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Changes in Urine albumin-to-creatinine ratio [UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)]
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Postoperative complications
Periodo de tiempo: at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24
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bleeding, infection, hepatic encephalopathy, ascites
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at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24
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BUN and UA level
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Changes in BUN and UA 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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Intraoperative variables
Periodo de tiempo: During the procedure of operation
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operation time, intraoperative blood loss, fluid infusion
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During the procedure of operation
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Albumin and bilirubin level
Periodo de tiempo: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Changes in Albumin and bilirubin 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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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-020
Información sobre medicamentos y dispositivos, documentos del estudio
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