- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07811700
Effect of LSD on Lipid Profiles Within 1 Year Postoperatively in Cirrhosis Patients With Portal Hypertension Bleeding (LSD-LPPH)
September 9, 2026 updated by: Guo-Qing Jiang, Northern Jiangsu People's Hospital
Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Lipid Profiles Within 1 Year Postoperatively n Cirrhosis Patients With Portal Hypertension Bleeding
Patients with liver cirrhosis frequently exhibit dyslipidemia due to impaired hepatic lipid synthesis, altered bile acid metabolism, and portal hypertension.
Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) is commonly used to treat Cirrhosis with Portal Hypertension Bleeding in these patients, but its impact on lipid profiles within 1 year postoperatively remains poorly characterized.
This study will follow patients undergoing LSD to measure changes in serum lipid parameters before and after surgery, identify risk factors for lipid profile deterioration or improvement, and determine whether LSD can ameliorate dyslipidemia in the long term, thereby informing metabolic management strategies in cirrhotic patients.
Study Overview
Status
Completed
Detailed Description
This study is a single-center retrospective medical record analysis.
Patients who had undergone laparoscopic splenectomy and azygoportal disconnection were screened and included in medical records.
Preoperative baseline data, as well as laboratory and clinical data at 3, 6, 9, and 12 months postoperatively, were extracted from the medical records to analyze the dynamic trends of four serum lipid parameters (total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol).
Intraoperative indicators, postoperative complications, albumin, bilirubin, and changes in Child-Pugh liver function classification were also collected as secondary outcome measures for statistical analysis.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China, 225001
- Clinical Medical College of Yangzhou University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Retrospective, single-center, observational cohort study.
Medical records of patients with cirrhosis, splenomegaly and hypersplenism, and portal hypertension bleeding who had undergone Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) were reviewed.
Preoperative baseline data and postoperative data at 3, 6, 9, and 12 months were extracted to evaluate dynamic changes in lipid profiles within 1 year postoperatively.
Description
Inclusion Criteria:
- Age 18-80 years, male or female
- Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
- Splenomegaly and hypersplenism
- History of portal hypertension bleeding (esophageal and gastric variceal bleeding )
- Child-Pugh Class A or B liver function
- Ability to complete 12-month follow-up
Exclusion Criteria:
- Child-Pugh Class C liver cirrhosis
- Previous abdominal surgery precluding safe laparoscopic splenectomy and azygoportal disconnection
- 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.
- Cirrhotic complications (hepatic encephalopathy, refractory ascites) within 1 month before surgery
- Pregnancy or lactation
- Poor compliance, inability to complete follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total triglycerides (TG) level
Time Frame: baseline, postoperative month 3, month 6, month 9, month 12,
|
Change in total triglycerides (TG) level
|
baseline, postoperative month 3, month 6, month 9, month 12,
|
|
Total cholesterol (TC) leve
Time Frame: baseline, and postoperative month 3, month 6, month 9,month 12
|
Change in total cholesterol (TC) level
|
baseline, and postoperative month 3, month 6, month 9,month 12
|
|
High-density lipoprotein cholesterol (HDL-C)
Time Frame: baseline, and postoperative month 3, month 6, month 9,month 12,
|
Change in high-density lipoprotein cholesterol (HDL-C) level
|
baseline, and postoperative month 3, month 6, month 9,month 12,
|
|
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: baseline, and postoperative month 3, month 6, month 9, month 12,
|
Change in low-density lipoprotein cholesterol (LDL-C) level
|
baseline, and postoperative month 3, month 6, month 9, month 12,
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
albumin, bilirubin
Time Frame: baseline, and postoperative month 3, month 6, month 9, month 12,
|
albumin, bilirubin level
|
baseline, and postoperative month 3, month 6, month 9, month 12,
|
|
Child-Pugh grade
Time Frame: baseline, and postoperative month 3, month 6, month 9,month 12,
|
Changes in Child-Pugh grade The Child-Pugh score is calculated based on five parameters, each assigned 1, 2, or 3 points.
1.
Total bilirubin · Less than 2 mg/dL: 1 point · 2-3 mg/dL: 2 points · Greater than 3 mg/dL: 3 points 2. 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 3. 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 4. Ascites · None: 1 point · Mild or controlled with diuretics: 2 points · Moderate to severe or refractory: 3 points 5. 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
|
baseline, and postoperative month 3, month 6, month 9,month 12,
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
May 1, 2025
Study Completion (Actual)
July 15, 2026
Study Registration Dates
First Submitted
September 3, 2026
First Submitted That Met QC Criteria
September 9, 2026
First Posted (Actual)
September 10, 2026
Study Record Updates
Last Update Posted (Actual)
September 10, 2026
Last Update Submitted That Met QC Criteria
September 9, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YZUC-024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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