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

NCT07588334 | Not Yet Recruiting

• 1 other identifier: YZUC-021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis, Liver; Portal Hypertension; Lipid Profiles; Splenectomy; Status

Keywords

Cirrhosis; Splenectomy; Laparoscopy; Lipid Profiles; azygoportal disconnection; Portal Hypertension Bleeding; hypersplenism

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Intraoperative variables

  During the procedure of operation

• Postoperative complications

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

• Albumin, bilirubin

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

• Child-Pugh grade

  at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Signed written informed consent
• Ability to complete 24-month follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Fibrosis; Hypersplenism

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Splenic Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Guo-Qing Jiang, MD

  Clinical Medical College of Yangzhou University

  STUDY CHAIR

Central Study Contacts

Guo-Qing Jiang, MD

CONTACT

+8651487373272; jgqing2003@hotmail.com

Dou-Sheng Bai, MD

CONTACT

+8651487373372; bdsno1@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

CN (1)