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
Studienübersicht
Status
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Guo-Qing Jiang, MD
- Telefonnummer: +8651487373272
- E-Mail: jgqing2003@hotmail.com
Studieren Sie die Kontaktsicherung
- Name: Dou-Sheng Bai, MD
- Telefonnummer: +8651487373372
- E-Mail: bdsno1@hotmail.com
Studienorte
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Jiangsu
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Yangzhou, Jiangsu, China, 225001
- Clinical Medical College of Yangzhou University
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Kontakt:
- Guo-Qing Jiang, MD
- Telefonnummer: +8651487373272
- E-Mail: jgqing2003@hotmail.com
-
Kontakt:
- Dou-Sheng Bai, MD
- Telefonnummer: +8651487373372
- E-Mail: bdsno1@hotmail.com
-
Unterermittler:
- Guo-Qing Jiang, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Glomerular filtration rate (eGFR)
Zeitfenster: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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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
|
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Serum creatinine (Scr) level
Zeitfenster: 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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Child-Pugh grade
Zeitfenster: 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 score and corresponding grade
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Urine albumin-to-creatinine ratio (UACR)
Zeitfenster: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Changes in Urine albumin-to-creatinine ratio [UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)]
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at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Postoperative complications
Zeitfenster: at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24
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bleeding, infection, hepatic encephalopathy, ascites
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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
Zeitfenster: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
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Changes in BUN and UA level
|
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
|
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Intraoperative variables
Zeitfenster: During the procedure of operation
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operation time, intraoperative blood loss, fluid infusion
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During the procedure of operation
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Albumin and bilirubin level
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- YZUC-020
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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