Actively Recruiting
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients
Led by Northern Jiangsu People's Hospital · Updated on 2025-05-30
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of laparoscopic splenectomy and azygoportal disconnection on improving liver reserve function in patients with liver cirrhosis. The study aims to determine whether this surgical treatment can enhance liver function after surgery and improve the overall prognosis for these patients. The investigation focuses on patients diagnosed with cirrhosis experiencing related complications such as splenomegaly and portal hypertension. Participants undergo laparoscopic splenectomy and azygoportal disconnection performed by the same surgical team. After surgery, a consistent treatment plan including medications and other therapies is followed. Liver reserve function indicators such as TBIL, DBIL, ALB, ALT, INR, PT, Child-Pugh score, ascites, prealbumin, and indocyanine green clearance tests (ICG-K, ICG-R 15, ICG-T/2) are monitored before surgery and at 3, 6, 12, and 24 months post-surgery to assess changes over time. Throughout the study, patients provide general information and receive nursing care from the same team. Follow-up visits are scheduled to monitor liver function and health status using blood tests and clinical assessments. The primary outcomes focus on liver reserve function measured by ICG clearance tests at multiple time points after surgery, with ongoing observation up to two years. The study participation duration may vary depending on follow-up timing and patient condition.
CONDITIONS
Brief Title
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve 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
- 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 hospital discharge
Participants undergo laparoscopic splenectomy and azygoportal disconnection performed by the surgical team, followed by nursing care after the operation.
1 surgical procedure and post-operative hospital stay
Duration - Up to 24 months
After surgery, participants receive a unified treatment plan including medication and other treatments.
Follow-up visits at 3, 6, 12, and 24 months after surgery
Duration - 24 months after surgery
Participants are monitored for liver reserve function and related indicators before surgery and at multiple timepoints after surgery.
Visits at 3, 6, 12, and 24 months post-surgery
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, 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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