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

A Prospective, Single-Center, Observational Cohort Study to Evaluate the Short-Term and Long-Term (2-Year) Effects of Laparoscopic Splenectomy on Renal Function in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Cirrhosis; Hypersplenism; Splenectomy; Status; Kidney Function Issue

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

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Guo-Qing Jiang, MD; Phone Number: +8651487373272; Email: jgqing2003@hotmail.com
• Study Contact Backup: Name: Dou-Sheng Bai, MD; Phone Number: +8651487373372; Email: bdsno1@hotmail.com

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Clinical Medical College of Yangzhou University
      • Contact: Guo-Qing Jiang, MD; Phone Number: +8651487373272; Email: jgqing2003@hotmail.com
      • Contact: Dou-Sheng Bai, MD; Phone Number: +8651487373372; Email: bdsno1@hotmail.com
      • Sub-Investigator: Guo-Qing Jiang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 bilirubinLess than 2 mg/dL: 1 point2-3 mg/dL: 2 pointsGreater than 3 mg/dL: 3 points; Serum albuminGreater than 3.5 g/dL: 1 point2.8-3.5 g/dL: 2 pointsLess than 2.8 g/dL: 3 points; Prothrombin time prolongation or INRProlongation less than 4 seconds (INR < 1.7): 1 pointProlongation 4-6 seconds (INR 1.7-2.3): 2 pointsProlongation greater than 6 seconds (INR > 2.3): 3 points; AscitesNone: 1 pointMild or controlled with diuretics: 2 pointsModerate to severe or refractory: 3 points; Hepatic encephalopathyNone: 1 pointGrade I-II: 2 pointsGrade 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	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)]	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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
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
Intraoperative variables	operation time, intraoperative blood loss, fluid infusion	During the procedure of operation
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

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital
• Investigators: Study Chair: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cirrhosis; Laparoscopy; Splenectomy; Portal Hypertension; Hypersplenism
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Lymphatic Diseases; Splenic Diseases; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Fibrosis; Hypertension, Portal; Hypersplenism
• Other Study ID Numbers: YZUC-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No