CirrhosisLS-RFNCT07585773
Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)
An observational study of Cirrhosis and Splenectomy; Status, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Splenectomy; Status, Hypersplenism
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 28 Feb 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001
Guo-Qing Jiang, MD, +8651487373272, jgqing2003@hotmail.com
Dou-Sheng Bai, MD, +8651487373372, bdsno1@hotmail.com
About this study
Official title: 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 .
Read the detailed description
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
- Conditions
- Cirrhosis, Splenectomy; Status, Hypersplenism, Kidney Function Issue
- Keywords
- Cirrhosis, Portal Hypertension, Splenectomy, Laparoscopy, Hypersplenism
- Medical subject headings
- Fibrosis, Hypersplenism, Hypertension, Portal
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
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Glomerular filtration rate (eGFR)
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.
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Secondary outcomes (6)
BUN and UA level
Changes in BUN and UA level
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Urine albumin-to-creatinine ratio (UACR)
Changes in Urine albumin-to-creatinine ratio [UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)]
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Intraoperative variables
operation time, intraoperative blood loss, fluid infusion
Measured: During the procedure of operation
Postoperative complications
bleeding, infection, hepatic encephalopathy, ascites
Measured: 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
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
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Albumin and bilirubin level
Changes in Albumin and bilirubin level
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 May 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Years
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
- Guo-Qing Jiang, MD, Study chair, Clinical Medical College of Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585773
- Sponsor's protocol ID
- YZUC-020
- Acronym
- LS-RF
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07585773
- Acronym / sponsor ID
- LS-RF / YZUC-020
- Conditions
- Cirrhosis, Splenectomy; Status, Hypersplenism, Kidney Function Issue
- Keywords
- Cirrhosis, Portal Hypertension, Splenectomy, Laparoscopy, Hypersplenism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 14 May 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 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 .
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
6 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 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.
Guo-Qing Jiang, MD study chair
Clinical Medical College of Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Splenectomy; Status, run by Northern Jiangsu People's Hospital at 1 site in China.
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 8 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: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo-Qing Jiang, MD (+8651487373272, jgqing2003@hotmail.com), or a site near the patient. 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 1, month 3, month 6, month 12, month 18, month 24). 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 18 May 2026.