Cirrhosis, Hypersplenism, Kidney Function Issue, Splenectomy; Status
Conditions
Keywords
Cirrhosis, Portal Hypertension, Splenectomy, Laparoscopy, Hypersplenism
Brief 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 .
Detailed description
Rationale: 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, splenomegaly and hypersplenism frequently have subclinical or overt renal impairment preoperatively. Laparoscopic splenectomy (LS) is a standard intervention for hypersplenism, but perioperative stress, hemodynamic fluctuations, and surgical trauma may further compromise renal function and laparoscopic splenectomy may improve the kidney function in the long term. Current evidence lacks prospective, 2-year data on renal function changes after LS in this high-risk population, especially regarding the hepatorenal axis and long-term renal outcomes. This study aims to fill this gap to guide perioperative renal protection strategies. Study Design: Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, splenomegaly and hypersplenism scheduled for elective laparoscopic splenectomy will be enrolled and followed for 2 years to assess renal function dynamics and identify risk factors for renal injury . Study Timeline: * Months 1-6: Patient screening, enrollment, baseline assessment * Months 1-18: Laparoscopic splenectomy and perioperative short-term renal function monitoring * Months 7-24: Long-term follow-up at 3, 6, 12, 24 months postoperatively * Month 24: Data analysis and study completion
Interventions
None listed
Sponsors
Northern Jiangsu People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BUN and UA level | at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 | Changes in BUN and UA level |
| Urine albumin-to-creatinine ratio (UACR) | at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 | Changes in Urine albumin-to-creatinine ratio \[UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)\] |
| Intraoperative variables | During the procedure of operation | operation time, intraoperative blood loss, fluid infusion |
| Postoperative complications | at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24 | bleeding, infection, hepatic encephalopathy, ascites |
| Child-Pugh grade | at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 | Changes in Child-Pugh grade The Child-Pugh score is calculated based on five parameters, each assigned 1, 2, or 3 points. 1. Total bilirubin * Less than 2 mg/dL: 1 point * 2-3 mg/dL: 2 points * Greater than 3 mg/dL: 3 points 2. Serum albumin * Greater than 3.5 g/dL: 1 point * 2.8-3.5 g/dL: 2 points * Less than 2.8 g/dL: 3 points 3. Prothrombin time prolongation or INR * Prolongation less than 4 seconds (INR \< 1.7): 1 point * Prolongation 4-6 seconds (INR 1.7-2.3): 2 points * Prolongation greater than 6 seconds (INR \> 2.3): 3 points 4. Ascites * None: 1 point * Mild or controlled with diuretics: 2 points * Moderate to severe or refractory: 3 points 5. Hepatic encephalopathy * None: 1 point * Grade I-II: 2 points * Grade III-IV: 3 points Total score and corresponding grade * 5-6 points: Child-Pugh class A * 7-9 points: Child-Pugh class B * 10-15 points: Child-Pugh class C |
| Albumin and bilirubin level | at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 | Changes in Albumin and bilirubin level |
Countries
China
Contacts
CONTACTGuo-Qing Jiang, MD
CONTACTDou-Sheng Bai, MD
STUDY_CHAIRGuo-Qing Jiang, MD
Clinical Medical College of Yangzhou University
Outcome results
None listed