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

14. mai 2026 oppdatert av: 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 .

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Jiangsu
      • Yangzhou, Jiangsu, Kina, 225001
        • Clinical Medical College of Yangzhou University
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Guo-Qing Jiang, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Glomerular filtration rate (eGFR)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Child-Pugh grade
Tidsramme: 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.

  1. Total bilirubin

    • Less than 2 mg/dL: 1 point
    • 2-3 mg/dL: 2 points
    • Greater than 3 mg/dL: 3 points

  2. 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

  3. 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

  4. Ascites

    • None: 1 point
    • Mild or controlled with diuretics: 2 points
    • Moderate to severe or refractory: 3 points

  5. 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: During the procedure of operation
operation time, intraoperative blood loss, fluid infusion
During the procedure of operation
Albumin and bilirubin level
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Northern Jiangsu People's Hospital

Etterforskere

  • Studiestol: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

28. februar 2029

Studiet fullført (Antatt)

28. februar 2029

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

10. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • YZUC-020

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