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CompletedNCT07811700LSD-LPPHUpdated Sep 10, 2026

Effect of LSD on Lipid Profiles Within 1 Year Postoperatively in Cirrhosis Patients With Portal Hypertension Bleeding

An observational study in Lipid Profiles, Cirrhosis, Liver and Portal Hypertension, sponsored by Northern Jiangsu People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Northern Jiangsu People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Cirrhosis
  • Splenectomy
  • Laparoscopy
  • Lipid Profiles
  • azygoportal disconnection
  • hypersplenism
  • Portal Hypertension Bleeding
03

In context

Liver Cirrhosis

1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.

This study's enrollment of 150 is below the median of 171 across 526 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Northern Jiangsu People's Hospital is the lead sponsor of 61 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. Class A or B liver function
  6. Ability to complete 12-month follow-up

Exclusion criteria

Exclusion Criteria:

  1. 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 diseases.
  6. Cirrhotic complications (hepatic encephalopathy, ascites) within 1 month before surgery
  7. Pregnancy or lactation
  8. Poor compliance, inability to complete follow-up
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Total triglycerides (TG) level

    Change in total triglycerides (TG) level

    Time frame: baseline, postoperative month 3, month 6, month 9, month 12,

  2. Total cholesterol (TC) leve

    Change in total cholesterol (TC) level

    Time frame: baseline, and postoperative month 3, month 6, month 9,month 12

  3. High-density lipoprotein cholesterol (HDL-C)

    Change in high-density lipoprotein cholesterol (HDL-C) level

    Time frame: baseline, and postoperative month 3, month 6, month 9,month 12,

  4. Low-density lipoprotein cholesterol (LDL-C)

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

    Time frame: baseline, and postoperative month 3, month 6, month 9, month 12,

Secondary outcomes

  1. albumin, bilirubin

    albumin, bilirubin level

    Time frame: baseline, and postoperative month 3, month 6, month 9, month 12,

  2. 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. 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

    Time frame: baseline, and postoperative month 3, month 6, month 9,month 12,

07

Study locations

1 site
  • Clinical Medical College of Yangzhou University
    Yangzhou, Jiangsu 225001, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2022 to primary completion in May 2025, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 10, 2026
StartActual
May 1, 2022
Primary completionActual
May 1, 2025
CompletionActual
Jul 15, 2026
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07811700
Lead sponsor
Northern Jiangsu People's Hospital
Responsible party
Guo-Qing Jiang (Clinical Professor, Northern Jiangsu People's Hospital) — Principal investigator
First posted
Sep 10, 2026
Start date
May 1, 2022
Primary completion
May 1, 2025
Completion
Jul 15, 2026
Last update
Sep 10, 2026

Study contacts

Guo-Qing Jiang, MD
study chair · Clinical Medical College of Yangzhou University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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