Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)

NCT07585773 · tracked via the Priya Life Science China tracker

Sponsor

Northern Jiangsu People's Hospital

Phase

Observational

Started

2026-05-01

Last updated

2026-05-18

Condition(s) studied

CirrhosisSplenectomy; StatusHypersplenismKidney Function Issue

Study summary

Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether laparoscopic splenectomy can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging) 2. Splenomegaly and hypersplenism 3. No history of portal hypertension bleeding (esophageal and gastric variceal bleeding ) 4. Age 18-80 years, male or female 5. Child-Pugh Class A or B liver function 6. No history of primary renal disease or acute kidney injury (AKI) 7. Signed written informed consent 8. Ability to complete 24-month follow-up Exclusion Criteria: 1. Child-Pugh Class C liver cirrhosis 2. Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.) 3. Previous abdominal surgery precluding safe laparoscopic splenectomy 4. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders 5. Cirrhotic complications (portal hypertension bleeding, hepatic encephalopathy, refractory ascites) within 1 month before surgery 6. Pregnancy or lactation 7. Poor compliance, inability to complete follow-up

Primary outcome measure(s)

Serum creatinine (Scr) level — at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in serum creatinine (Scr) level
Glomerular filtration rate (eGFR) — at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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.

Trial sites (1)

Facility	City	Region	Status
Clinical Medical College of Yangzhou University	Yangzhou	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07585773 on ClinicalTrials.gov ↗ ← All trials in China