CirrhosisLS-LP-CHNCT07588373
Effect of Laparoscopic Splenectomy on Lipid Profiles 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 frequently exhibit dyslipidemia due to impaired hepatic lipid synthesis, altered bile acid metabolism, and portal hypertension. Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on lipid profiles over 2 years remains poorly… 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
- No healthy volunteers
- Adult, Older adult
Study population: A 24-month (2-year) prospective, single-center, observational cohort study. Patients with liver cirrhosis and hypersplenism scheduled for elective laparoscopic splenectomy will be recruited and followed up for 2 years to evaluate dynamic changes in lipid profiles.
Who may be able to join
- Age 18-80 years, male or female
- Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
- Splenomegaly and hypersplenism
- Child-Pugh Class A or B liver function
- Signed written informed consent
- Ability to complete 24-month follow-up
Who cannot join
- Child-Pugh Class C liver cirrhosis
- No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
- Previous abdominal surgery precluding safe laparoscopic splenectomy.
- Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
- Metabolic/endocrine diseases: Familial hyperlipidemia; uncontrolled severe diabetes mellitus, thyroid dysfunction, nephrotic syndrome; use of lipid-lowering drugs, hormones, or other drugs affecting blood lipids within 1 month before surgery.
- Infections/inflammatory diseases: Active hepatitis, severe infections, or autoimmune diseases.
Show all 9Show fewer
- Cirrhotic complications (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
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 Lipid Profiles in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism
Patients with liver cirrhosis frequently exhibit dyslipidemia due to impaired hepatic lipid synthesis, altered bile acid metabolism, and portal hypertension. Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on lipid profiles over 2 years remains poorly characterized. This study will follow patients undergoing laparoscopic splenectomy to measure changes in serum lipid parameters before and after surgery, identify risk factors for lipid profile deterioration or improvement, and determine whether laparoscopic splenectomy can ameliorate dyslipidemia in the long term, thereby informing metabolic management strategies in cirrhotic patients.
Read the detailed description
Rationale: Liver cirrhosis disrupts hepatic lipid homeostasis through multiple mechanisms, including decreased apolipoprotein synthesis, impaired cholesterol esterification, and altered very-low-density lipoprotein (VLDL) secretion, resulting in characteristic lipid abnormalities such as hypocholesterolemia and low high-density lipoprotein cholesterol (HDL-C). Hypersplenism further complicates this metabolic profile through increased lipid peroxidation and inflammatory cytokine-mediated dysregulation of lipid metabolism. Laparoscopic splenectomy (LS) reduces splenic sequestration and inflammatory burden, potentially improving hepatic lipid synthetic capacity and peripheral lipid clearance. However, perioperative stress responses, anesthetic effects, and abrupt hemodynamic changes may transiently worsen lipid profiles. Current evidence lacks prospective, 2-year data on lipid profile dynamics after LS in this population, particularly regarding the trajectory of total cholesterol, triglycerides, LDL-C, HDL-C. This study aims to fill this gap to guide perioperative metabolic monitoring and long-term dyslipidemia management.
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 lipid profile dynamics and identify risk factors for metabolic deterioration or improvement.
Study Timeline:
Months 1-6: Patient screening, enrollment, baseline lipid assessment Months 1-18: Laparoscopic splenectomy and perioperative short-term lipid monitoring Months 7-24: Long-term follow-up at 3, 6, 9,12, 24 months postoperatively Month 24: Data analysis and study completion
- Conditions
- Cirrhosis, Splenectomy; Status, Hypersplenism, Lipid Profiles
- Keywords
- Cirrhosis, Splenectomy, Laparoscopy, Lipid Profiles, Hypersplenism, portal hypertension
- Medical subject headings
- Fibrosis, Hypersplenism, Hypertension, Portal
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol (TC) level
Change in total cholesterol (TC) level
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Total triglycerides (TG) level
Change in total triglycerides (TG) level
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
High-density lipoprotein cholesterol (HDL-C) level
Change in high-density lipoprotein cholesterol (HDL-C)
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Low-density lipoprotein cholesterol (LDL-C) level
Change in low-density lipoprotein cholesterol (LDL-C)
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Secondary outcomes (4)
Intraoperative variables
operation time, intraoperative blood loss, fluid infusion, mean arterial pressure
Measured: During the procedure of operation
Postoperative complications
postoperative complications (bleeding, infection, hepatic encephalopathy, ascites)
Measured: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Albumin, bilirubin
Changes in albumin, bilirubin
Measured: at preoperative baseline, postoperative 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
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
- NCT07588373
- Sponsor's protocol ID
- YZUC-019
- Acronym
- LS-LP-CH
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 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 Lipid Profiles in Patients With Liver Cirrhosis, Splenomegaly and Hypersplenism
- ClinicalTrials.gov ID
- NCT07588373
- Acronym / sponsor ID
- LS-LP-CH / YZUC-019
- Conditions
- Cirrhosis, Splenectomy; Status, Hypersplenism, Lipid Profiles
- Keywords
- Cirrhosis, Splenectomy, Laparoscopy, Lipid Profiles, Hypersplenism, portal hypertension
- 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 frequently exhibit dyslipidemia due to impaired hepatic lipid synthesis, altered bile acid metabolism, and portal hypertension. Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on lipid profiles over 2 years remains poorly characterized. This study will follow patients undergoing laparoscopic splenectomy to measure changes in serum lipid parameters before and after surgery, identify risk factors for lipid profile deterioration or improvement, and determine whether laparoscopic splenectomy can ameliorate dyslipidemia in the long term, thereby informing metabolic management strategies in cirrhotic patients.
Detailed description
Rationale: Liver cirrhosis disrupts hepatic lipid homeostasis through multiple mechanisms, including decreased apolipoprotein synthesis, impaired cholesterol esterification, and altered very-low-density lipoprotein (VLDL) secretion, resulting in characteristic lipid abnormalities such as hypocholesterolemia and low high-density lipoprotein cholesterol (HDL-C). Hypersplenism further complicates this metabolic profile through increased lipid peroxidation and inflammatory cytokine-mediated dysregulation of lipid metabolism. Laparoscopic splenectomy (LS) reduces splenic sequestration and inflammatory burden, potentially improving hepatic lipid synthetic capacity and peripheral lipid clearance. However, perioperative stress responses, anesthetic effects, and abrupt hemodynamic changes may transiently worsen lipid profiles. Current evidence lacks prospective, 2-year data on lipid profile dynamics after LS in this population, particularly regarding the trajectory of total cholesterol, triglycerides, LDL-C, HDL-C. This study aims to fill this gap to guide perioperative metabolic monitoring and long-term dyslipidemia management.
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 lipid profile dynamics and identify risk factors for metabolic deterioration or improvement.
Study Timeline:
Months 1-6: Patient screening, enrollment, baseline lipid assessment Months 1-18: Laparoscopic splenectomy and perioperative short-term lipid monitoring Months 7-24: Long-term follow-up at 3, 6, 9,12, 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
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A 24-month (2-year) prospective, single-center, observational cohort study. Patients with liver cirrhosis and hypersplenism scheduled for elective laparoscopic splenectomy will be recruited and followed up for 2 years to evaluate dynamic changes in lipid profiles.
Key inclusion criteria (6 listed)
- Age 18-80 years, male or female
- Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
- Splenomegaly and hypersplenism
- Child-Pugh Class A or B liver function
- Signed written informed consent
Key exclusion criteria (9 listed)
- Child-Pugh Class C liver cirrhosis
- No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )
- Previous abdominal surgery precluding safe laparoscopic splenectomy.
- Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
- Metabolic/endocrine diseases: Familial hyperlipidemia; uncontrolled severe diabetes mellitus, thyroid dysfunction, nephrotic syndrome; use of lipid-lowering drugs, hormones, or other drugs affecting blood lipids 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
Total cholesterol (TC) level
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in total cholesterol (TC) level
Total triglycerides (TG) level
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in total triglycerides (TG) level
High-density lipoprotein cholesterol (HDL-C) level
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in high-density lipoprotein cholesterol (HDL-C)
Low-density lipoprotein cholesterol (LDL-C) level
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Change in low-density lipoprotein cholesterol (LDL-C)
4 secondary outcomes
Intraoperative variables
Time frame: During the procedure of operation
Postoperative complications
Time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Albumin, bilirubin
Time frame: at preoperative baseline, postoperative 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
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 14 May 2026.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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 6 inclusion and 9 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 14 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?
Total cholesterol (TC) level (time frame: at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24). The study lists 4 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 14 May 2026.