Clinical trial NCT05338294: The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients
Official title: The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cirrhosis, Liver
Splenectomy; Status
Keywords: Cirrhosis
Splenectomy
Laparoscopy
Immune function
Azygoportal disconnection
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The immune function CD4+ at 3 months after surgery
timeFrame: 3 months
measure: The immune function CD4+ at 6 months after surgery
timeFrame: 6 months
measure: The immune function CD4+ at 12 months after surgery
timeFrame: 12 months
measure: The immune function CD4+ at 24 months after surgery
timeFrame: 24 months
measure: The immune function CD8+ at 3 months after surgery
timeFrame: 3 months
measure: The immune function CD8+ at 6 months after surgery
timeFrame: 6 months
measure: The immune function CD8+ at 12 months after surgery
timeFrame: 12 months
measure: The immune function CD8+ at 24 months after surgery
timeFrame: 24 months
measure: The immune function CD4+/CD8+ at 3 months after surgery
timeFrame: 3 months
measure: The immune function CD4+/CD8+ at 6 months after surgery
timeFrame: 6 months
measure: The immune function CD4+/CD8+ at 12 months after surgery
timeFrame: 12 months
measure: The immune function CD4+/CD8+ at 24 months after surgery
timeFrame: 24 months
measure: The immune function CD19 at 3 months after surgery
timeFrame: 3 months
measure: The immune function CD19 at 6 months after surgery
timeFrame: 6 months
measure: The immune function CD19 at 12 months after surgery
timeFrame: 12 months
measure: The immune function CD19 at 24 months after surgery
timeFrame: 24 months
measure: The immune function CD20 at 3 months after surgery
timeFrame: 3 months
measure: The immune function CD20 at 6 months after surgery
timeFrame: 6 months
measure: The immune function CD20 at 12 months after surgery
timeFrame: 12 months
measure: The immune function CD20 at 24 months after surgery
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Clinical Medical College, Yangzhou University
state: Jiangsu
Study officials:
affiliation: Clinical Medical College, Yangzhou University
name: Guo-Qing Jiang, MD
role: STUDY_CHAIR
References: