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

Cirrhosis, Liver Clinical Trial

— ELSDI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338294
• Other study ID #: YZUC-011
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: December 2023
• Source: Northern Jiangsu People's Hospital
• Contact: Guo-Qing Jiang, MD
• Phone: +8651487373382
• Email: jgqing2003[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis
• Splenectomy; Status

Intervention

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

Locations

Country	Name	City	State
China	Clinical Medical College, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The immune function CD4+ at 3 months after surgery	The level of the immune function CD4+ at 3 months after surgery	3 months
Primary	The immune function CD4+ at 6 months after surgery	The level of the immune function CD4+ at 6 months after surgery	6 months
Primary	The immune function CD4+ at 12 months after surgery	The level of the immune function CD4+ at 12 months after surgery	12 months
Primary	The immune function CD4+ at 24 months after surgery	The level of the immune function CD4+ at 24 months after surgery	24 months
Primary	The immune function CD8+ at 3 months after surgery	The level of the immune function CD8+ at 3 months after surgery	3 months
Primary	The immune function CD8+ at 6 months after surgery	The level of the immune function CD8+ at 6 months after surgery	6 months
Primary	The immune function CD8+ at 12 months after surgery	The level of the immune function CD8+ at 12 months after surgery	12 months
Primary	The immune function CD8+ at 24 months after surgery	The level of the immune function CD8+ at 24 months after surgery	24 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	The immune function CD19 at 3 months after surgery	The level of the immune function CD19 at 3 months after surgery	3 months
Primary	The immune function CD19 at 6 months after surgery	The level of the immune function CD19 at 6 months after surgery	6 months
Primary	The immune function CD19 at 12 months after surgery	The level of the immune function CD19 at 12 months after surgery	12 months
Primary	The immune function CD19 at 24 months after surgery	The level of the immune function CD19 at 24 months after surgery	24 months
Primary	The immune function CD20 at 3 months after surgery	The level of the immune function CD20 at 3 months after surgery	3 months
Primary	The immune function CD20 at 6 months after surgery	The level of the immune function CD20 at 6 months after surgery	6 months
Primary	The immune function CD20 at 12 months after surgery	The level of the immune function CD20 at 12 months after surgery	12 months
Primary	The immune function CD20 at 24 months after surgery	The level of the immune function CD20 at 24 months after surgery	24 months