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

Northern Jiangsu People's Hospital

Status: Completed

Conditions: Splenectomy; Status; Cirrhosis, Liver

Treatments: Procedure: Laparoscopic splenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05339269

YZUC-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Laparoscopic splenectomy

Experimental group

Description:

The laparoscopic splenectomy is performed by the same surgical team.

Treatment:

Procedure: Laparoscopic splenectomy