Actively Recruiting
The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
Led by Northern Jiangsu People's Hospital · Updated on 2025-10-03
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare immune function changes in patients with liver cirrhosis who undergo laparoscopic partial splenectomy to see if this surgery can improve immune function and patient outcomes. The study focuses on patients with cirrhosis and hypersplenism, evaluating whether preserving part of the spleen during surgery offers benefits over full spleen removal. Patients are randomly assigned to one of two groups: one receiving a standard laparoscopic splenectomy where the entire spleen is removed, and the other undergoing laparoscopic partial splenectomy that preserves some blood vessels and spleen tissue. All surgeries are done by the same team, with patients receiving standardized postoperative care and treatments. Monitoring occurs before surgery and at 7 days, 1, 3, 6, and 12 months afterward, including blood tests, liver function, immune markers, and blood flow in relevant veins. Special liver function tests using indocyanine green are done at 3, 6, and 12 months. Participants will have regular follow-up visits with blood tests measuring immune markers, blood cell counts, hemoglobin levels, and blood flow and vessel size in portal and splenic veins. Researchers will monitor for complications such as portal vein thrombosis up to 12 months post-surgery. The main outcomes are changes in immune markers and blood flow at 6 months, with additional measures tracked at other time points up to one year. The study lasts at least 12 months post-operation for thorough assessment.
CONDITIONS
Brief Title
Laparoscopic Partial Splenectomy for Hypersplenism in Liver 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
- 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 30 days postoperation
Participants undergo laparoscopic partial splenectomy or laparoscopic splenectomy surgery followed by standardized post-operative care and treatment.
1 surgery visit and approximately 6 post-operative visits within 30 days
Duration - 12 months postoperation
Participants attend follow-up visits for monitoring including blood tests, liver function, coagulation profile, immune function, and vascular hemodynamics at multiple timepoints.
Visits at 7 days, 1, 3, 6, 9, and 12 months postoperation
Trial Site Locations
Total: 1 location
1
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, China, 225001
Actively Recruiting
Research Team
G
Guo-Qing Jiang
D
Dou-Sheng Bai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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