Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001, China
Location contact
Dou-Sheng Bai, MD
CONTACT
Guo-Qing Jiang, MD
CONTACT
Guo-Qing Jiang, MD
SUB_INVESTIGATOR
NCT Number: NCT07585773
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 .
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Yangzhou, Jiangsu, 225001, China
Dou-Sheng Bai, MD
CONTACT
Guo-Qing Jiang, MD
CONTACT
Guo-Qing Jiang, MD
SUB_INVESTIGATOR
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:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in serum creatinine (Scr) level
Time frame: 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.
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Changes in BUN and UA level
Time frame: 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)]
Time frame: During the procedure of operation
operation time, intraoperative blood loss, fluid infusion
Time frame: 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
Time frame: 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
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Changes in Albumin and bilirubin level
Contact information is provided by the study sponsor or research team.
Dou-Sheng Bai, MD
CONTACT
Guo-Qing Jiang, MD
CONTACT
Northern Jiangsu People's Hospital
Other
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
Acronym: LS-RF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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