Cirrhosis, LiverNCT07811713
Effect of LSD on Renal Function in Cirrhotic Patients With Portal Hypertension
An observational study of Cirrhosis, Liver and Splenectomy; Status, run by Northern Jiangsu People's Hospital.
Trial summary
Patients with liver cirrhosis and portal hypertension often have impaired kidney function due to reduced blood flow to the kidneys and fluid buildup in the abdomen (ascites). Laparoscopy splenectomy and azygoportal disconnection (LSD) is a minimally invasive surgery commonly used to treat bleeding from swollen veins… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Splenectomy; Status, Renal Function Abnormal
- What is being tested?
- Laparoscopic splenectomy and azygoportal disconnection
- Type of treatment
- Surgery or procedure
- How many people
- 496 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: This is a retrospective, single-center, observational cohort study. The study population consists of adult patients with liver cirrhosis, splenomegaly and hypersplenism, and portal hypertension bleeding who underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at the Department of Hepatobiliary Surgery, Subei People's Hospital Affiliated to Yangzhou University between February 2012 and February 2025. Patients were identified from electronic medical records and followed for up to 12 months postoperatively to assess renal function dynamics. The study aimed to evaluate the effect of LSD on renal function recovery and identify factors associated with postoperative renal outcomes in this high-risk population.
Who may be able to join
- Age ≥18 years.
- Diagnosis of liver cirrhosis with portal hypertension.
- Underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at our institution.
- Adequate preoperative and postoperative clinical and follow-up data for analysis.
- Preoperative and postoperative eGFR data available at the specified time points (baseline, month 3, 6, 9, and 12).
Who cannot join
- Child-Pugh Class C liver cirrhosis.
- Primary renal diseases (e.g., glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.).
- Previous abdominal surgery that precluded safe laparoscopic splenectomy and azygoportal disconnection (LSD).
- Severe cardiac, pulmonary, or cerebrovascular dysfunction; malignant tumors; or primary hematological disorders.
- Hepatic encephalopathy or refractory ascites within 1 month before surgery.
- Pregnancy or lactation.
- Poor compliance or inability to complete follow-up.
About this study
Official title: Effect of Laparoscopy Splenectomy and Azygoportal Disconnectionon Renal Function in Cirrhotic Patients With Portal Hypertension
Patients with liver cirrhosis and portal hypertension often have impaired kidney function due to reduced blood flow to the kidneys and fluid buildup in the abdomen (ascites). Laparoscopy splenectomy and azygoportal disconnection (LSD) is a minimally invasive surgery commonly used to treat bleeding from swollen veins in these patients, but its impact on kidney function recovery remains unclear.
This study will review medical records of patients with liver cirrhosis and portal hypertension who underwent LSD at our hospital. We will measure kidney function using estimated glomerular filtration rate (eGFR) before surgery and at 3, 6, 9, and 12 months after surgery to evaluate changes over time. We will also examine whether factors such as fluid buildup in the abdomen (ascites) before surgery are associated with kidney function changes after LSD.
The goal is to better understand how LSD affects kidney function in these patients and to identify factors that may predict kidney function recovery, which could help improve care for cirrhotic patients undergoing this surgery.
Read the 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 and portal hypertension frequently have subclinical or overt renal impairment preoperatively. Laparoscopy splenectomy and azygoportal disconnection (LSD) is a standard intervention for cirrhotic patients with portal hypertension, but its impact on long-term renal function recovery remains unclear.
This single-center retrospective cohort study will be conducted at the Department of Hepatobiliary Surgery, Subei People's Hospital Affiliated to Yangzhou University, Yangzhou, China. We will retrospectively collect clinical and follow-up data from patients with liver cirrhosis and portal hypertension who underwent LSD between February 2012 and February 2025.
Patients will be stratified into two groups based on preoperative estimated glomerular filtration rate (eGFR): impaired renal function group (<90 mL/min/1.73m²) and normal renal function group (≥90 mL/min/1.73m²). Kidney function will be assessed using eGFR calculated with the 2021 CKD-EPI creatinine equation at five time points: preoperative baseline and postoperative months 3, 6, 9, and 12.
Statistical analyses will include linear mixed-effects models (LMM) to evaluate eGFR change trajectories and group differences over time; multivariable linear regression to identify factors independently associated with eGFR change (ΔeGFR = postoperative month 12 eGFR - preoperative eGFR); and multivariable logistic regression (limited to patients with baseline eGFR <90 mL/min/1.73m²) to identify predictors of renal function recovery to normal (eGFR ≥90 mL/min/1.73m²).
The study aims to evaluate whether LSD is associated with kidney function improvement in patients with liver cirrhosis and portal hypertension, whether the degree of improvement differs between patients with and without pre-existing renal impairment, and whether preoperative factors such as ascites severity are associated with the magnitude of renal function recovery. These findings may help fill an important gap in understanding the hepatorenal axis after LSD and guide perioperative renal protection strategies in this high-risk population.
- Being tested
- Laparoscopic splenectomy and azygoportal disconnection
- Keywords
- Cirrhosis, Splenectomy, Laparoscopy, azygoportal disconnection, Renal function, Portal hypertension bleeding
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic splenectomy and azygoportal disconnectionProcedure or surgery
A minimally invasive surgical procedure involving laparoscopic removal of the spleen and ligation of perigastric and esophageal varices to reduce portal hypertension and prevent variceal bleeding.
| Study group | Role | What they receive |
|---|---|---|
| LSD-treated Patients with Liver Cirrhosis and Portal Hypertension | Patients who underwent laparoscopy splenectomy and azygoportal disconnection for liver cirrhosis with portal hypertension Receives: Procedure: Laparoscopic splenectomy and azygoportal disconnection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Creatinine (Scr) Level
Change in serum creatinine (Scr) level, used for eGFR calculation.
Measured: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Estimated Glomerular Filtration Rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) calculated using the 2021 CKD-EPI creatinine equation. eGFR was assessed at preoperative baseline and postoperative months 3, 6, 9, and 12 to evaluate longitudinal renal function changes.
Measured: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Secondary outcomes (5)
Blood Urea Nitrogen (BUN) Level
Changes in BUN level as additional indicators of renal function.
Measured: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Blood Uric Acid (UA) Level
Changes in UA level as additional indicators of renal function.
Measured: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Postoperative Complications
Postoperative complications including bleeding, infection, hepatic encephalopathy, and ascites.
Measured: At postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12
Albumin
Changes in serum albumin levels.
Measured: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Total Bilirubin Level
Changes in serum total bilirubin levels.
Measured: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startFeb 2012
- Primary completionFeb 2026
- Study completionAug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
- Investigators
- guoqing jiang, Study chair, Clinical Medical College, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811713
- Sponsor's protocol ID
- YZUC-025
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopy Splenectomy and Azygoportal Disconnectionon Renal Function in Cirrhotic Patients With Portal Hypertension
- ClinicalTrials.gov ID
- NCT07811713
- Acronym / sponsor ID
- YZUC-025
- Keywords
- Cirrhosis, Splenectomy, Laparoscopy, azygoportal disconnection, Renal function, Portal hypertension bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Feb 2026 (actual)
- Study completion
- Aug 2026 (actual)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with liver cirrhosis and portal hypertension often have impaired kidney function due to reduced blood flow to the kidneys and fluid buildup in the abdomen (ascites). Laparoscopy splenectomy and azygoportal disconnection (LSD) is a minimally invasive surgery commonly used to treat bleeding from swollen veins in these patients, but its impact on kidney function recovery remains unclear.
This study will review medical records of patients with liver cirrhosis and portal hypertension who underwent LSD at our hospital. We will measure kidney function using estimated glomerular filtration rate (eGFR) before surgery and at 3, 6, 9, and 12 months after surgery to evaluate changes over time. We will also examine whether factors such as fluid buildup in the abdomen (ascites) before surgery are associated with kidney function changes after LSD.
The goal is to better understand how LSD affects kidney function in these patients and to identify factors that may predict kidney function recovery, which could help improve care for cirrhotic patients undergoing this surgery.
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 and portal hypertension frequently have subclinical or overt renal impairment preoperatively. Laparoscopy splenectomy and azygoportal disconnection (LSD) is a standard intervention for cirrhotic patients with portal hypertension, but its impact on long-term renal function recovery remains unclear.
This single-center retrospective cohort study will be conducted at the Department of Hepatobiliary Surgery, Subei People's Hospital Affiliated to Yangzhou University, Yangzhou, China. We will retrospectively collect clinical and follow-up data from patients with liver cirrhosis and portal hypertension who underwent LSD between February 2012 and February 2025.
Patients will be stratified into two groups based on preoperative estimated glomerular filtration rate (eGFR): impaired renal function group (<90 mL/min/1.73m²) and normal renal function group (≥90 mL/min/1.73m²). Kidney function will be assessed using eGFR calculated with the 2021 CKD-EPI creatinine equation at five time points: preoperative baseline and postoperative months 3, 6, 9, and 12.
Statistical analyses will include linear mixed-effects models (LMM) to evaluate eGFR change trajectories and group differences over time; multivariable linear regression to identify factors independently associated with eGFR change (ΔeGFR = postoperative month 12 eGFR - preoperative eGFR); and multivariable logistic regression (limited to patients with baseline eGFR <90 mL/min/1.73m²) to identify predictors of renal function recovery to normal (eGFR ≥90 mL/min/1.73m²).
The study aims to evaluate whether LSD is associated with kidney function improvement in patients with liver cirrhosis and portal hypertension, whether the degree of improvement differs between patients with and without pre-existing renal impairment, and whether preoperative factors such as ascites severity are associated with the magnitude of renal function recovery. These findings may help fill an important gap in understanding the hepatorenal axis after LSD and guide perioperative renal protection strategies in this high-risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LSD-treated Patients with Liver Cirrhosis and Portal Hypertension | – | Procedure: Laparoscopic splenectomy and azygoportal disconnectionPatients who underwent laparoscopy splenectomy and azygoportal disconnection for liver cirrhosis with portal hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective, single-center, observational cohort study. The study population consists of adult patients with liver cirrhosis, splenomegaly and hypersplenism, and portal hypertension bleeding who underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at the Department of Hepatobiliary Surgery, Subei People's Hospital Affiliated to Yangzhou University between February 2012 and February 2025. Patients were identified from electronic medical records and followed for up to 12 months postoperatively to assess renal function dynamics. The study aimed to evaluate the effect of LSD on renal function recovery and identify factors associated with postoperative renal outcomes in this high-risk population.
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Diagnosis of liver cirrhosis with portal hypertension.
- Underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at our institution.
- Adequate preoperative and postoperative clinical and follow-up data for analysis.
- Preoperative and postoperative eGFR data available at the specified time points (baseline, month 3, 6, 9, and 12).
Key exclusion criteria (7 listed)
- Child-Pugh Class C liver cirrhosis.
- Primary renal diseases (e.g., glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.).
- Previous abdominal surgery that precluded safe laparoscopic splenectomy and azygoportal disconnection (LSD).
- Severe cardiac, pulmonary, or cerebrovascular dysfunction; malignant tumors; or primary hematological disorders.
- Hepatic encephalopathy or refractory ascites within 1 month before surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic splenectomy and azygoportal disconnectionA minimally invasive surgical procedure involving laparoscopic removal of the spleen and ligation of perigastric and esophageal varices to reduce portal hypertension and prevent variceal bleeding. | Procedure or surgery | LSD-treated Patients with Liver Cirrhosis and Portal Hypertension |
Primary outcome
Serum Creatinine (Scr) Level
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Change in serum creatinine (Scr) level, used for eGFR calculation.
Estimated Glomerular Filtration Rate (eGFR)
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Change in estimated glomerular filtration rate (eGFR) calculated using the 2021 CKD-EPI creatinine equation. eGFR was assessed at preoperative baseline and postoperative months 3, 6, 9, and 12 to evaluate longitudinal renal function changes.
5 secondary outcomes
Blood Urea Nitrogen (BUN) Level
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Blood Uric Acid (UA) Level
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Postoperative Complications
Time frame: At postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12
Albumin
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Total Bilirubin Level
Time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
guoqing jiang study chair
Clinical Medical College, Yangzhou University
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver and Splenectomy; Status, run by Northern Jiangsu People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Creatinine (Scr) Level (time frame: At preoperative baseline, postoperative month 3, month 6, month 9, month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.