Effect of LSD on Renal Function in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver, Splenectomy; Status, Renal Function Abnormal, Portal Hypertension. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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 .
Detailed description
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.
Primary outcome measures
- Serum creatinine (Scr) level [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Glomerular filtration rate (eGFR) [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- BUN and UA level [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Urine albumin-to-creatinine ratio (UACR) [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
Secondary outcome measures (4)
- Intraoperative variables [Time frame: During the procedure of operation]
- 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]
- Child-Pugh grade [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
- Albumin and bilirubin level [Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07585786 · YZUC-022