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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 .
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:
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| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine (Scr) level | Change in serum creatinine (Scr) level | at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 |
| Glomerular filtration rate (eGFR) | 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. | at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| BUN and UA level | Changes in BUN and UA level | at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 |
| Urine albumin-to-creatinine ratio (UACR) | Changes in Urine albumin-to-creatinine ratio [UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)] |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo-Qing Jiang, MD | Contact | +8651487373272 | jgqing2003@hotmail.com | |
| Dou-Sheng Bai, MD | Contact | +8651487373372 | bdsno1@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guo-Qing Jiang, MD | Clinical Medical College of Yangzhou University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Medical College of Yangzhou University | Yangzhou | Jiangsu | 225001 | China |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006971 | Hypersplenism |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013158 | Splenic Diseases |
| D008206 | Lymphatic Diseases |
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| at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 |
| Intraoperative variables | operation time, intraoperative blood loss, fluid infusion | During the procedure of operation |
| Postoperative complications | bleeding, infection, hepatic encephalopathy, ascites | at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24 |
| Child-Pugh grade | Changes in Child-Pugh grade The Child-Pugh score is calculated based on five parameters, each assigned 1, 2, or 3 points.
Total score and corresponding grade
| at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 |
| Albumin and bilirubin level | Changes in Albumin and bilirubin level | at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24 |
| D006425 | Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |