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

2026년 5월 14일 업데이트: 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 .

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Guo-Qing Jiang, MD
전화번호: +8651487373272
이메일: jgqing2003@hotmail.com

연구 연락처 백업

이름: Dou-Sheng Bai, MD
전화번호: +8651487373372
이메일: bdsno1@hotmail.com

연구 장소

중국
- Jiangsu
  - Yangzhou, Jiangsu, 중국, 225001
    - Clinical Medical College of Yangzhou University
    - 연락하다:
      
      Guo-Qing Jiang, MD
      
      전화번호: +8651487373272
      
      이메일: jgqing2003@hotmail.com
    - 연락하다:
      
      Dou-Sheng Bai, MD
      
      전화번호: +8651487373372
      
      이메일: bdsno1@hotmail.com
    - 부수사관:
      
      Guo-Qing Jiang, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

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해당 없음

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연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Glomerular filtration rate (eGFR) 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Child-Pugh grade 기간: 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) 기간: 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 기간: 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 기간: 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 기간: During the procedure of operation	operation time, intraoperative blood loss, fluid infusion	During the procedure of operation
Albumin and bilirubin level 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Northern Jiangsu People's Hospital

수사관

연구 의자: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

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