Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Splenectomy; Status, Hypersplenism, Kidney Function Issue. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Primary outcome measures
- Serum creatinine (Scr) level [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Glomerular filtration rate (eGFR) [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
Secondary outcome measures (6)
- BUN and UA level [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Urine albumin-to-creatinine ratio (UACR) [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Intraoperative variables [Time frame: During the procedure of operation]
- Postoperative complications [Time frame: 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 [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Albumin and bilirubin level [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
- Splenomegaly and hypersplenism
- No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
- Age 18-80 years, male or female
- Child-Pugh Class A or B liver function
- No history of primary renal disease or acute kidney injury (AKI)
- Signed written informed consent
- Ability to complete 24-month follow-up
Exclusion criteria
- Child-Pugh Class C liver cirrhosis
- Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.)
- Previous abdominal surgery precluding safe laparoscopic splenectomy
- Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
- Cirrhotic complications (portal hypertension bleeding, hepatic encephalopathy, refractory ascites) within 1 month before surgery
- Pregnancy or lactation
- Poor compliance, inability to complete follow-up
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Clinical Medical College of Yangzhou University — Yangzhou
Identifiers
NCT: NCT07585773 · YZUC-020