NCT07811700

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 3, 2026

Last Update Submit

September 9, 2026

Conditions

Keywords

CirrhosisSplenectomyLaparoscopyLipid Profilesazygoportal disconnectionhypersplenismPortal Hypertension Bleeding

Outcome Measures

Primary Outcomes (4)

  • Total triglycerides (TG) level

    Change in total triglycerides (TG) level

    baseline, postoperative month 3, month 6, month 9, month 12,

  • Total cholesterol (TC) leve

    Change in total cholesterol (TC) level

    baseline, and postoperative month 3, month 6, month 9,month 12

  • High-density lipoprotein cholesterol (HDL-C)

    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)

    Change in low-density lipoprotein cholesterol (LDL-C) level

    baseline, and postoperative month 3, month 6, month 9, month 12,

Secondary Outcomes (2)

  • albumin, bilirubin

    baseline, and postoperative month 3, month 6, month 9, month 12,

  • Child-Pugh grade

    baseline, and postoperative month 3, month 6, month 9,month 12,

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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
  • Ability to complete 12-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

Liver CirrhosisHypertension, PortalFibrosisHypersplenism

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSplenic DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Guo-Qing Jiang, MD

    Clinical Medical College of Yangzhou University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 10, 2026

Study Start

May 1, 2022

Primary Completion

May 1, 2025

Study Completion

July 15, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09

Locations