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

Not Applicable

Completed

• Conditions: Cirrhosis, Liver; Splenectomy; Status
• Interventions: Procedure: Laparoscopic splenectomy

• Registration Number: NCT05339269
• Lead Sponsor: Northern Jiangsu People's Hospital

Brief Summary

In this study, the investigators compared the improvement of and azygoportal disconnection related indicators in patients with liver cirrhosis after laparoscopic splenectomy. 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 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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-21
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
• Splenomegaly with secondary hypersplenism, Platelet count < 50*10^9/L
• 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
• Bleeding portal hypertension
• Human immunodeficiency virus (HIV) infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic splenectomy	Laparoscopic splenectomy	The laparoscopic splenectomy is performed by the same surgical team.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Medical College, Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China