The Effect of Laparoscopic Splenectomy on Liver Reserve Function for Cirrhosis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic splenectomy.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Liver, Splenectomy; Status. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
In this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy. To determine whether surgical treatment can help enhance postoperative liver reserve 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 liver reserve function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including TBIL, DBIL, ALB, ALT, INR, PT, Child-Pugh, ascites, prealbumin, ICG-K, ICG-R 15 and ICG-T/2.
Interventions
- Procedure Laparoscopic splenectomy
The laparoscopic splenectomy was performed by the same surgical team.
Primary outcome measures
- Liver reserve function ICG-K level at 3 months after surgery [Time frame: 3 months]
- Liver reserve function ICG-K level at 6 months after surgery. [Time frame: 6 months]
- Liver reserve function ICG-K level at 12 months after surgery [Time frame: 12 months]
- Liver reserve function ICG-K level at 24 months after surgery. [Time frame: 24 months]
- Liver reserve function ICG-R15 level at 3 months after surgery. [Time frame: 3 months]
- Liver reserve function ICG-R15 level at 6 months after surgery. [Time frame: 6 months]
- Liver reserve function ICG-R15 level at 12 months after surgery. [Time frame: 12 months]
- Liver reserve function ICG-R15 level at 24 months after surgery. [Time frame: 24 months]
- Liver reserve function ICG-T/2 level at 3 months after surgery. [Time frame: 3 months]
- Liver reserve function ICG-T/2 level at 6 months after surgery. [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Clinical Medical College of Yangzhou University — Yangzhou
Identifiers
NCT: NCT05325424 · YZUC-006