Cirrhosis, Liver, Portal Hypertension, Renal Function Abnormal, Splenectomy; Status
Conditions
Keywords
Cirrhosis, Splenectomy, Laparoscopy, azygoportal disconnection, Renal function, Portal hypertension bleeding
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 and Azygoportal Disconnection (LSD) is commonly used to treat Cirrhosis with Portal Hypertension Bleeding 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 LSD can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .
Detailed description
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, Portal Hypertension Bleeding frequently have subclinical or overt renal impairment preoperatively. LSD is a standard intervention for Cirrhosis Patients With Portal Hypertension Bleeding, but perioperative stress, hemodynamic fluctuations, and surgical trauma may further compromise renal function, and LSD may improve 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.
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. 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 and azygoportal disconnection 4. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders 5. Hepatic encephalopathy or 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. |
| 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 \[UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | postoperative complications (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 |
Contacts
CONTACTGuo-Qing Jiang, MD
CONTACTDou-Sheng Bai, MD
STUDY_CHAIRGuo-Qing Jiang, MD
Clinical Medical College of Yangzhou University
Outcome results
None listed