- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Serum Creatinine (Scr) Level
Időkeret: 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)
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Blood Urea Nitrogen (BUN) Level
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: guoqing jiang, Clinical Medical College, Yangzhou University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- YZUC-025
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