Actively Recruiting
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Immune Function for Patients with Liver Cirrhosis
Led by Northern Jiangsu People's Hospital · Updated on 2025-05-28
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating changes in immune function after laparoscopic splenectomy and azygoportal disconnection in patients with liver cirrhosis. The study aims to determine whether this surgical treatment can improve immune indicators and patient prognosis following surgery. This research focuses on patients with cirrhosis complicated by splenomegaly and gastroesophageal variceal bleeding. Participants undergo laparoscopic splenectomy and azygoportal disconnection performed by the same surgical team. After surgery, a unified treatment plan including medications and other therapies is provided. Immune function is monitored by measuring leukocytes, neutrophils, lymphocytes, monocytes, and immune cell markers such as CD4+, CD8+, CD19, and CD20 at multiple time points: before surgery, and at 3, 6, 12, and 24 months post-surgery. During the study, patients provide general health information and receive nursing care from the same team. Follow-up visits include blood tests to assess immune cell counts and ratios. Researchers track these immune markers over two years to understand changes after surgery and treatment. The study began in March 2022 and will conclude in July 2025, with safety and immune function closely monitored throughout.
CONDITIONS
Brief Title
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Hepatocellular carcinoma or any other malignancy
- Child-Pugh grade C liver disease
- Recent peptic ulcer disease
- History of hemorrhagic stroke
- Pregnancy
- Uncontrolled hypertension
- Human immunodeficiency virus (HIV) infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo laparoscopic splenectomy and azygoportal disconnection performed by the same surgical team, followed by nursing care after the operation.
1 surgical visit and immediate post-operative care visits
Duration - Ongoing after surgery
Participants receive a unified treatment plan after surgery, including medication and other treatments.
Visits as needed for medication and treatment management
Duration - 24 months
Participants are monitored for immune function related indicators before surgery and at 3, 6, 12, and 24 months after surgery.
Follow-up visits at 3, 6, 12, and 24 months post-surgery
Trial Site Locations
Total: 1 location
1
Clinical Medical College, Yangzhou University
Yangzhou, Jiangsu, China, 225001
Actively Recruiting
Research Team
G
Guo-Qing Jiang, MD
D
Dou-Sheng Bai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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