An observational study in Cirrhosis, Liver, Splenectomy; Status and Renal Function Abnormal, sponsored by Northern Jiangsu People's Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Northern Jiangsu People's Hospital · Observational
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.
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 496 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Northern Jiangsu People's Hospital is the lead sponsor of 61 studies on the registry; 31 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who underwent laparoscopy splenectomy and azygoportal disconnection for liver cirrhosis with portal hypertension
Procedure: Laparoscopic splenectomy and azygoportal disconnection
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.
Serum Creatinine (Scr) Level
Change in serum creatinine (Scr) level, used for eGFR calculation.
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Estimated Glomerular Filtration Rate (eGFR)
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.
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Blood Urea Nitrogen (BUN) Level
Changes in BUN level as additional indicators of renal function.
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Blood Uric Acid (UA) Level
Changes in UA level as additional indicators of renal function.
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Postoperative Complications
Postoperative complications including bleeding, infection, hepatic encephalopathy, and ascites.
Time frame: At postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12
Albumin
Changes in serum albumin levels.
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Total Bilirubin Level
Changes in serum total bilirubin levels.
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
No study locations are listed for this record.
Ran from Feb 2012 to primary completion in Feb 2026, 168 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Northern Jiangsu People's Hospital