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

14 mei 2026 bijgewerkt door: Guo-Qing Jiang, Northern Jiangsu People's Hospital

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 .

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Geschat)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Guo-Qing Jiang, MD
Telefoonnummer: +8651487373272
E-mail: jgqing2003@hotmail.com

Studie Contact Back-up

Naam: Dou-Sheng Bai, MD
Telefoonnummer: +8651487373372
E-mail: bdsno1@hotmail.com

Studie Locaties

China
- Jiangsu
  - Yangzhou, Jiangsu, China, 225001
    - Clinical Medical College of Yangzhou University
    - Contact:
      
      Guo-Qing Jiang, MD
      
      Telefoonnummer: +8651487373272
      
      E-mail: jgqing2003@hotmail.com
    - Contact:
      
      Dou-Sheng Bai, MD
      
      Telefoonnummer: +8651487373372
      
      E-mail: bdsno1@hotmail.com
    - Onderonderzoeker:
      
      Guo-Qing Jiang, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

NVT

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Glomerular filtration rate (eGFR) Tijdsspanne: 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.	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Serum creatinine (Scr) level Tijdsspanne: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Change in serum creatinine (Scr) level	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Child-Pugh grade Tijdsspanne: 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. Total bilirubin Less than 2 mg/dL: 1 point 2-3 mg/dL: 2 points Greater than 3 mg/dL: 3 points 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 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 Ascites None: 1 point Mild or controlled with diuretics: 2 points Moderate to severe or refractory: 3 points 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	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Urine albumin-to-creatinine ratio (UACR) Tijdsspanne: 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)]	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Postoperative complications Tijdsspanne: at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24	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 Tijdsspanne: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Changes in BUN and UA level	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Intraoperative variables Tijdsspanne: During the procedure of operation	operation time, intraoperative blood loss, fluid infusion	During the procedure of operation
Albumin and bilirubin level Tijdsspanne: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24	Changes in Albumin and bilirubin level	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Northern Jiangsu People's Hospital

Onderzoekers

Studie stoel: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

28 februari 2029

Studie voltooiing (Geschat)

28 februari 2029

Studieregistratiedata

Eerst ingediend

22 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

14 mei 2026

Laatst geverifieerd