The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients

NCT05338294 · tracked via the Priya Life Science China tracker

Sponsor

Northern Jiangsu People's Hospital

Phase

Not applicable

Started

2022-03-01

Last updated

2025-05-28

Condition(s) studied

Cirrhosis, LiverSplenectomy; Status

Investigational drug(s) / intervention(s)

Laparoscopic splenectomy and azygoportal disconnection

Laparoscopic splenectomy and azygoportal disconnection: Laparoscopic splenectomy and azygoportal disconnection is performed by the same surgical team.

Study summary

In this study, the investigators compared the improvement of immune function related indicators in patients with liver cirrhosis after laparoscopic splenectomy and azygoportal disconnection. To determine whether surgical treatment can help enhance postoperative immune function and improve patient prognosis.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * A clinical, radiological or histologic diagnosis of cirrhosis of any etiology * Splenomegaly with secondary hypersplenism * gastroesophageal variceal bleeding * Informed consent to participate in the study Exclusion Criteria: * Hepatocellular carcinoma or any other malignancy, * Child-Pugh grade C * Recent peptic ulcer disease * History of Hemorrhagic stroke * Pregnancy. * Uncontrolled Hypertension * Human immunodeficiency virus (HIV) infection

Primary outcome measure(s)

The immune function CD4+ at 3 months after surgery — 3 months
The level of the immune function CD4+ at 3 months after surgery
The immune function CD4+ at 6 months after surgery — 6 months
The level of the immune function CD4+ at 6 months after surgery
The immune function CD4+ at 12 months after surgery — 12 months
The level of the immune function CD4+ at 12 months after surgery
The immune function CD4+ at 24 months after surgery — 24 months
The level of the immune function CD4+ at 24 months after surgery
The immune function CD8+ at 3 months after surgery — 3 months
The level of the immune function CD8+ at 3 months after surgery
The immune function CD8+ at 6 months after surgery — 6 months
The level of the immune function CD8+ at 6 months after surgery
The immune function CD8+ at 12 months after surgery — 12 months
The level of the immune function CD8+ at 12 months after surgery
The immune function CD8+ at 24 months after surgery — 24 months
The level of the immune function CD8+ at 24 months after surgery
The immune function CD4+/CD8+ at 3 months after surgery — 3 months
The level of the immune function CD4+/CD8+ at 3 months after surgery
The immune function CD4+/CD8+ at 6 months after surgery — 6 months
The level of the immune function CD4+/CD8+ at 6 months after surgery
The immune function CD4+/CD8+ at 12 months after surgery — 12 months
The level of the immune function CD4+/CD8+ at 12 months after surgery
The immune function CD4+/CD8+ at 24 months after surgery — 24 months
The level of the immune function CD4+/CD8+ at 24 months after surgery
The immune function CD19 at 3 months after surgery — 3 months
The level of the immune function CD19 at 3 months after surgery
The immune function CD19 at 6 months after surgery — 6 months
The level of the immune function CD19 at 6 months after surgery
The immune function CD19 at 12 months after surgery — 12 months
The level of the immune function CD19 at 12 months after surgery
The immune function CD19 at 24 months after surgery — 24 months
The level of the immune function CD19 at 24 months after surgery
The immune function CD20 at 3 months after surgery — 3 months
The level of the immune function CD20 at 3 months after surgery
The immune function CD20 at 6 months after surgery — 6 months
The level of the immune function CD20 at 6 months after surgery
The immune function CD20 at 12 months after surgery — 12 months
The level of the immune function CD20 at 12 months after surgery
The immune function CD20 at 24 months after surgery — 24 months
The level of the immune function CD20 at 24 months after surgery

Trial sites (1)

Facility	City	Region	Status
Clinical Medical College, Yangzhou University	Yangzhou	Jiangsu	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05338294 on ClinicalTrials.gov ↗ ← All trials in China