Effect of LSD on Lipid Profiles in Cirrhosis Patients With Portal Hypertension Bleeding (2-Year Follow-Up) (LSD-LPPH)

A Prospective, Single-Center, Observational Cohort Study to Evaluate the Long-Term (2-Year) Effects of Laparoscopic Splenectomy and Azygoportal Disconnection on Lipid Profiles in Patients With Liver Cirrhosis, 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 over 2 years 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: Not yet recruiting
• Conditions: Portal Hypertension; Cirrhosis, Liver; Splenectomy; Status; Lipid Profiles

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). Laparoscopic splenectomy combined with azygoportal disconnection (LSD) is commonly used to treat portal hypertension bleeding in these patients, but its impact on lipid profiles over 2 years 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 Cirrhosis with Portal Hypertension Bleeding in these patients.Study Design: Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with Cirrhosis with Portal Hypertension Bleeding scheduled for elective LSD 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 Azygoportal Disconnection and perioperative short-term lipid monitoring Months 7-24: Long-term follow-up at 3, 6, 9,12, 24 months postoperativelyMonth 24: Data analysis and study completion.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Guo-Qing Jiang, MD; Phone Number: +8651487373272; Email: jgqing2003@hotmail.com
• Study Contact Backup: Name: Dou-Sheng Bai, MD; Phone Number: +8651487373372; Email: bdsno1@hotmail.com

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Clinical Medical College of Yangzhou University
      • Contact: Guo-Qing Jiang, MD; Phone Number: +8651487373272; Email: jgqing2003@hotmail.com
      • Contact: Dou-Sheng Bai, MD; Phone Number: +8651487373372; Email: bdsno1@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, Splenomegaly and hypersplenism, Portal Hypertension Bleeding scheduled for Laparoscopic Splenectomy and Azygoportal Disconnection (LSD) will be enrolled and followed for 2 years to evaluate dynamic changes in lipid profiles.

Description

Inclusion Criteria:

1. Age 18-80 years, male or female
2. Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)
3. Splenomegaly and hypersplenism
4. History of portal hypertension bleeding (esophageal and gastric variceal bleeding )
5. Child-Pugh Class A or B liver function
6. Signed written informed consent
7. Ability to complete 24-month follow-up

Exclusion Criteria:

1. Child-Pugh Class C liver cirrhosis
2. Previous abdominal surgery precluding safe laparoscopic splenectomy and azygoportal disconnection
3. Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders
4. 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.
5. Infections/inflammatory diseases: Active hepatitis, severe infections, or autoimmune diseases.
6. Cirrhotic complications (hepatic encephalopathy, refractory ascites) within 1 month before surgery
7. Pregnancy or lactation
8. Poor compliance, inability to complete follow-up

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cholesterol (TC) level	Change in total cholesterol (TC) level	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	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
High-density lipoprotein cholesterol (HDL-C)	Change in high-density lipoprotein cholesterol (HDL-C) level	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Low-density lipoprotein cholesterol (LDL-C)	Change in low-density lipoprotein cholesterol (LDL-C) level	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 bilirubinLess than 2 mg/dL: 1 point2-3 mg/dL: 2 pointsGreater than 3 mg/dL: 3 points; Serum albuminGreater than 3.5 g/dL: 1 point2.8-3.5 g/dL: 2 pointsLess than 2.8 g/dL: 3 points; Prothrombin time prolongation or INRProlongation less than 4 seconds (INR < 1.7): 1 pointProlongation 4-6 seconds (INR 1.7-2.3): 2 pointsProlongation greater than 6 seconds (INR > 2.3): 3 points; AscitesNone: 1 pointMild or controlled with diuretics: 2 pointsModerate to severe or refractory: 3 points; Hepatic encephalopathyNone: 1 pointGrade I-II: 2 pointsGrade 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	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, mean arterial pressure,	During the procedure of operation
Postoperative complications	bleeding, infection, hepatic encephalopathy, ascites	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
Albumin, bilirubin	Changes in Child-Pugh grade, albumin, bilirubin	at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Collaborators and Investigators

• Sponsor: Northern Jiangsu People's Hospital
• Investigators: Study Chair: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 10, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cirrhosis; Laparoscopy; Splenectomy; Lipid Profiles; azygoportal disconnection; Portal Hypertension Bleeding; hypersplenism
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Lymphatic Diseases; Splenic Diseases; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Fibrosis; Liver Cirrhosis; Hypertension, Portal; Hypersplenism
• Other Study ID Numbers: YZUC-021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No