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NCT Number: NCT07585786

Effect of LSD on Renal Function in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)

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 and Azygoportal Disconnection (LSD) is commonly used to treat Cirrhosis with Portal Hypertension Bleeding 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 LSD can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .

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Key information

Conditions

Cirrhosis, Liver Digestive System Diseases Fibrosis Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Renal Function Abnormal Splenectomy; Status

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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, Portal Hypertension Bleeding frequently have subclinical or overt renal impairment preoperatively. LSD is a standard intervention for Cirrhosis Patients With Portal Hypertension Bleeding, but perioperative stress, hemodynamic fluctuations, and surgical trauma may further compromise renal function, and LSD may improve 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
  • Splenomegaly and hypersplenism
  • 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 and azygoportal disconnection
  • Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
  • Hepatic encephalopathy or refractory ascites within 1 month before surgery
  • Pregnancy or lactation
  • Poor compliance, inability to complete follow-up

Treatment and study plan

Primary outcomes

  1. Serum creatinine (Scr) level

    Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

    Change in serum creatinine (Scr) level

  2. Glomerular filtration rate (eGFR)

    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.

  3. BUN and UA level

    Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

    Changes in BUN and UA level

  4. Urine albumin-to-creatinine ratio (UACR)

    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)]

Secondary outcomes

  1. Intraoperative variables

    Time frame: During the procedure of operation

    operation time, intraoperative blood loss, fluid infusion

  2. Postoperative complications

    Time frame: at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24

    postoperative complications (bleeding, infection, hepatic encephalopathy, ascites)

  3. Child-Pugh grade

    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 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

  4. Albumin and bilirubin level

    Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

    Changes in albumin and bilirubin level

Study contacts

Contact information is provided by the study sponsor or research team.

Dou-Sheng Bai, MD

CONTACT

[email protected]

+8651487373372

Guo-Qing Jiang, MD

CONTACT

[email protected]

+8651487373272

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

A Prospective, Single-Center, Observational Cohort Study to Evaluate the Long-Term (2-Year) Effects of Laparoscopic Splenectomy and Azygoportal Disconnection on Renal Function in Patients With Liver Cirrhosis, Portal Hypertension Bleeding

Acronym: LSD-RFPH

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 14, 2026
Registry last updated
May 18, 2026

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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