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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
The patients were enrolled according to the research criteria, and collected the general basic information of the patients. After the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy and azygoportal disconnection, and the same nursing team performed the nursing after the operation. Then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. During the treatment, the immune function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including the counts of leukocytes, neutrophils, lymphocytes, and monocytes, and the levels of CD4+,CD8+,CD4+/CD8+, and CD19,CD20.

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

Conditions
-----------------
Cirrhosis, Liver, Splenectomy; Status

Intervention / Treatment
-----------------
* Procedure: Laparoscopic splenectomy and azygoportal disconnection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic splenectomy and azygoportal disconnection<br>Laparoscopic splenectomy and azygoportal disconnection was performed by the same surgical team. | Procedure: Laparoscopic splenectomy and azygoportal disconnection<br>* Laparoscopic splenectomy and azygoportal disconnection is performed by the same surgical team.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The immune function CD4+ at 3 months after surgery | The level of the immune function CD4+ at 3 months after surgery | 3 months | 
| The immune function CD4+ at 6 months after surgery | The level of the immune function CD4+ at 6 months after surgery | 6 months | 
| The immune function CD4+ at 12 months after surgery | The level of the immune function CD4+ at 12 months after surgery | 12 months | 
| The immune function CD4+ at 24 months after surgery | The level of the immune function CD4+ at 24 months after surgery | 24 months | 
| The immune function CD8+ at 3 months after surgery | The level of the immune function CD8+ at 3 months after surgery | 3 months | 
| The immune function CD8+ at 6 months after surgery | The level of the immune function CD8+ at 6 months after surgery | 6 months | 
| The immune function CD8+ at 12 months after surgery | The level of the immune function CD8+ at 12 months after surgery | 12 months | 
| The immune function CD8+ at 24 months after surgery | The level of the immune function CD8+ at 24 months after surgery | 24 months | 
| The immune function CD4+/CD8+ at 3 months after surgery | The level of the immune function CD4+/CD8+ at 3 months after surgery | 3 months | 
| The immune function CD4+/CD8+ at 6 months after surgery | The level of the immune function CD4+/CD8+ at 6 months after surgery | 6 months | 
| The immune function CD4+/CD8+ at 12 months after surgery | The level of the immune function CD4+/CD8+ at 12 months after surgery | 12 months | 
| The immune function CD4+/CD8+ at 24 months after surgery | The level of the immune function CD4+/CD8+ at 24 months after surgery | 24 months | 
| The immune function CD19 at 3 months after surgery | The level of the immune function CD19 at 3 months after surgery | 3 months | 
| The immune function CD19 at 6 months after surgery | The level of the immune function CD19 at 6 months after surgery | 6 months | 
| The immune function CD19 at 12 months after surgery | The level of the immune function CD19 at 12 months after surgery | 12 months | 
| The immune function CD19 at 24 months after surgery | The level of the immune function CD19 at 24 months after surgery | 24 months | 
| The immune function CD20 at 3 months after surgery | The level of the immune function CD20 at 3 months after surgery | 3 months | 
| The immune function CD20 at 6 months after surgery | The level of the immune function CD20 at 6 months after surgery | 6 months | 
| The immune function CD20 at 12 months after surgery | The level of the immune function CD20 at 12 months after surgery | 12 months | 
| The immune function CD20 at 24 months after surgery | The level of the immune function CD20 at 24 months after surgery | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cirrhosis, Splenectomy, Laparoscopy, Immune function, Azygoportal disconnection