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

NCT ID: NCT05339269

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-11-30

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.

Conditions

Cirrhosis, Liver; Splenectomy; Status

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic splenectomy

The laparoscopic splenectomy is performed by the same surgical team.

Group Type: EXPERIMENTAL

Laparoscopic splenectomy

Intervention Type: PROCEDURE

The laparoscopic splenectomy is performed by the same surgical team.

Interventions

Laparoscopic splenectomy

The laparoscopic splenectomy is performed by the same surgical team.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Jiangsu People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guo-Qing Jiang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guo-Qing Jiang, MD

Role: STUDY_CHAIR

Clinical Medical College of Yangzhou University

Locations

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

YZUC-010

Identifier Type: -

Identifier Source: org_study_id