- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07811713
Effect of LSD on Renal Function in Cirrhotic Patients With Portal Hypertension
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of liver cirrhosis with portal hypertension.
- Underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at our institution.
- Adequate preoperative and postoperative clinical and follow-up data for analysis.
- Preoperative and postoperative eGFR data available at the specified time points (baseline, month 3, 6, 9, and 12).
Exclusion Criteria:
- Child-Pugh Class C liver cirrhosis.
- Primary renal diseases (e.g., glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.).
- Previous abdominal surgery that precluded safe laparoscopic splenectomy and azygoportal disconnection (LSD).
- Severe cardiac, pulmonary, or cerebrovascular dysfunction; malignant tumors; or primary hematological disorders.
- Hepatic encephalopathy or refractory ascites within 1 month before surgery.
- Pregnancy or lactation.
- Poor compliance or inability to complete follow-up.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum Creatinine (Scr) Level
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood Urea Nitrogen (BUN) Level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: guoqing jiang, Clinical Medical College, Yangzhou University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- YZUC-025
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