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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05339269
Acronym
ELSI
Enrollment
21
Registered
2022-04-21
Start date
2022-03-01
Completion date
2024-11-30
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver, Splenectomy; Status

Keywords

Cirrhosis, Splenectomy, Laparoscopy, Immune function

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.

Interventions

The laparoscopic splenectomy is performed by the same surgical team.

Sponsors

Northern Jiangsu People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The immune function CD4+ at 3 months after surgery3 monthsThe level of the immune function CD4+ at 3 months after surgery
The immune function CD4+ at 6 months after surgery6 monthsThe level of the immune function CD4+ at 6 months after surgery
The immune function CD4+ at 12 months after surgery12 monthsThe level of the immune function CD4+ at 12 months after surgery
The immune function CD4+ at 24 months after surgery24 monthsThe level of the immune function CD4+ at 24 months after surgery
The immune function CD8+ at 3 months after surgery3 monthsThe level of the immune function CD8+ at 3 months after surgery
The immune function CD8+ at 6 months after surgery6 monthsThe level of the immune function CD8+ at 6 months after surgery
The immune function CD8+ at 12 months after surgery12 monthsThe level of the immune function CD8+ at 12 months after surgery
The immune function CD8+ at 24 months after surgery24 monthsThe level of the immune function CD8+ at 24 months after surgery
The immune function CD4+/CD8+ at 3 months after surgery3 monthsThe level of the immune function CD4+/CD8+ at 3 months after surgery
The immune function CD4+/CD8+ at 6 months after surgery6 monthsThe level of the immune function CD4+/CD8+ at 6 months after surgery
The immune function CD4+/CD8+ at 12 months after surgery12 monthsThe level of the immune function CD4+/CD8+ at 12 months after surgery
The immune function CD4+/CD8+ at 24 months after surgery24 monthsThe level of the immune function CD4+/CD8+ at 24 months after surgery
The immune function CD19 at 3 months after surgery3 monthsThe level of the immune function CD19 at 3 months after surgery
The immune function CD19 at 6 months after surgery6 monthsThe level of the immune function CD19 at 6 months after surgery
The immune function CD19 at 12 months after surgery12 monthsThe level of the immune function CD19 at 12 months after surgery
The immune function CD19 at 24 months after surgery24 monthsThe level of the immune function CD19 at 24 months after surgery
The immune function CD20 at 3 months after surgery3 monthsThe level of the immune function CD20 at 3 months after surgery
The immune function CD20 at 6 months after surgery6 monthsThe level of the immune function CD20 at 6 months after surgery
The immune function CD20 at 12 months after surgery12 monthsThe level of the immune function CD20 at 12 months after surgery
The immune function CD20 at 24 months after surgery24 monthsThe level of the immune function CD20 at 24 months after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026