A Prospective, Single-Center, Observational Cohort Study to Evaluate the Long-Term (2-Year) Effects of Laparoscopic Splenectomy and Azygoportal Disconnection on Renal Function in Patients With Liver Cirrhosis, Portal Hypertension Bleeding
| Registry | NCT07585786, acronym LSD-RFPH |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 30 (Estimated) |
| Sponsor | Northern Jiangsu People's Hospital (Other) |
| Conditions | Cirrhosis, Liver, Splenectomy; Status, Renal Function Abnormal, Portal Hypertension |
| Dates | start 2026-05-01 (estimated), primary completion 2029-02-28 (estimated), completion 2029-02-28 (estimated), first posted 2026-05-14, last updated 2026-05-18 |
Related Papers Related Patents Related Grants Related Experts
All trials for Cirrhosis, Liver All trials for Splenectomy; Status
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 .
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.
Sex: All, ages: 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