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Effect of LSD on Renal Function in Cirrhotic Patients With Portal Hypertension

9 de septiembre de 2026 actualizado por: Guo-Qing Jiang, Northern Jiangsu People's Hospital

Effect of Laparoscopy Splenectomy and Azygoportal Disconnectionon Renal Function in Cirrhotic Patients With Portal Hypertension

Patients with liver cirrhosis and portal hypertension often have impaired kidney function due to reduced blood flow to the kidneys and fluid buildup in the abdomen (ascites). Laparoscopy splenectomy and azygoportal disconnection (LSD) is a minimally invasive surgery commonly used to treat bleeding from swollen veins in these patients, but its impact on kidney function recovery remains unclear.

This study will review medical records of patients with liver cirrhosis and portal hypertension who underwent LSD at our hospital. We will measure kidney function using estimated glomerular filtration rate (eGFR) before surgery and at 3, 6, 9, and 12 months after surgery to evaluate changes over time. We will also examine whether factors such as fluid buildup in the abdomen (ascites) before surgery are associated with kidney function changes after LSD.

The goal is to better understand how LSD affects kidney function in these patients and to identify factors that may predict kidney function recovery, which could help improve care for cirrhotic patients undergoing this surgery.

Descripción general del estudio

Descripción detallada

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 and portal hypertension frequently have subclinical or overt renal impairment preoperatively. Laparoscopy splenectomy and azygoportal disconnection (LSD) is a standard intervention for cirrhotic patients with portal hypertension, but its impact on long-term renal function recovery remains unclear.

This single-center retrospective cohort study will be conducted at the Department of Hepatobiliary Surgery, Subei People's Hospital Affiliated to Yangzhou University, Yangzhou, China. We will retrospectively collect clinical and follow-up data from patients with liver cirrhosis and portal hypertension who underwent LSD between February 2012 and February 2025.

Patients will be stratified into two groups based on preoperative estimated glomerular filtration rate (eGFR): impaired renal function group (<90 mL/min/1.73m²) and normal renal function group (≥90 mL/min/1.73m²). Kidney function will be assessed using eGFR calculated with the 2021 CKD-EPI creatinine equation at five time points: preoperative baseline and postoperative months 3, 6, 9, and 12.

Statistical analyses will include linear mixed-effects models (LMM) to evaluate eGFR change trajectories and group differences over time; multivariable linear regression to identify factors independently associated with eGFR change (ΔeGFR = postoperative month 12 eGFR - preoperative eGFR); and multivariable logistic regression (limited to patients with baseline eGFR <90 mL/min/1.73m²) to identify predictors of renal function recovery to normal (eGFR ≥90 mL/min/1.73m²).

The study aims to evaluate whether LSD is associated with kidney function improvement in patients with liver cirrhosis and portal hypertension, whether the degree of improvement differs between patients with and without pre-existing renal impairment, and whether preoperative factors such as ascites severity are associated with the magnitude of renal function recovery. These findings may help fill an important gap in understanding the hepatorenal axis after LSD and guide perioperative renal protection strategies in this high-risk population.

Tipo de estudio

De observación

Inscripción (Actual)

496

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

This is a retrospective, single-center, observational cohort study. The study population consists of adult patients with liver cirrhosis, splenomegaly and hypersplenism, and portal hypertension bleeding who underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at the Department of Hepatobiliary Surgery, Subei People's Hospital Affiliated to Yangzhou University between February 2012 and February 2025. Patients were identified from electronic medical records and followed for up to 12 months postoperatively to assess renal function dynamics. The study aimed to evaluate the effect of LSD on renal function recovery and identify factors associated with postoperative renal outcomes in this high-risk population.

Descripción

Inclusion Criteria:

  1. Age ≥18 years.
  2. Diagnosis of liver cirrhosis with portal hypertension.
  3. Underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at our institution.
  4. Adequate preoperative and postoperative clinical and follow-up data for analysis.
  5. Preoperative and postoperative eGFR data available at the specified time points (baseline, month 3, 6, 9, and 12).

Exclusion Criteria:

  1. Child-Pugh Class C liver cirrhosis.
  2. Primary renal diseases (e.g., glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.).
  3. Previous abdominal surgery that precluded safe laparoscopic splenectomy and azygoportal disconnection (LSD).
  4. Severe cardiac, pulmonary, or cerebrovascular dysfunction; malignant tumors; or primary hematological disorders.
  5. Hepatic encephalopathy or refractory ascites within 1 month before surgery.
  6. Pregnancy or lactation.
  7. Poor compliance or inability to complete follow-up.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
LSD-treated Patients with Liver Cirrhosis and Portal Hypertension
Patients who underwent laparoscopy splenectomy and azygoportal disconnection for liver cirrhosis with portal hypertension
A minimally invasive surgical procedure involving laparoscopic removal of the spleen and ligation of perigastric and esophageal varices to reduce portal hypertension and prevent variceal bleeding.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Serum Creatinine (Scr) Level
Periodo de tiempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Change in serum creatinine (Scr) level, used for eGFR calculation.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Estimated Glomerular Filtration Rate (eGFR)
Periodo de tiempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Change in estimated glomerular filtration rate (eGFR) calculated using the 2021 CKD-EPI creatinine equation. eGFR was assessed at preoperative baseline and postoperative months 3, 6, 9, and 12 to evaluate longitudinal renal function changes.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Urea Nitrogen (BUN) Level
Periodo de tiempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Changes in BUN level as additional indicators of renal function.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Blood Uric Acid (UA) Level
Periodo de tiempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Changes in UA level as additional indicators of renal function.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Postoperative Complications
Periodo de tiempo: At postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12
Postoperative complications including bleeding, infection, hepatic encephalopathy, and ascites.
At postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12
Albumin
Periodo de tiempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Changes in serum albumin levels.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Total Bilirubin Level
Periodo de tiempo: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Changes in serum total bilirubin levels.
At preoperative baseline, postoperative month 3, month 6, month 9, month 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: guoqing jiang, Clinical Medical College, Yangzhou University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de febrero de 2012

Finalización primaria (Actual)

1 de febrero de 2026

Finalización del estudio (Actual)

1 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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