Laparoscopic Partial Splenectomy for Hypersplenism in Liver 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 Partial Splenectomy.
- Who it may be relevant to
- Registry conditions: Cirrhoses, Liver, Splenectomy; Status, Partial. 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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Official title
The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
Overview
In this study,the researchers compared the changes in immune function-related indicators in patients with liver cirrhosis following laparoscopic partial splenectomy,to determine whether this surgical intervention can enhance postoperative immune function and thereby improve patient outcomes.
Detailed description
Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Eligible patients were randomly assigned in a 1:1 ratio to two groups: the laparoscopic splenectomy group and the laparoscopic partial splenectomy group, using a computer-generated randomization sequence. Following comprehensive preoperative preparation, all surgeries were performed by the same surgical team. The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.
Postoperatively, all patients received standardized care from the same nursing team, followed by a uniform treatment protocol that included pharmacotherapy, additional therapeutic interventions, and follow-up assessments. Throughout the treatment period, monitoring was performed preoperatively and at 7 days, 1, 3, 6, and 12 months postoperatively. The parameters monitored included routine blood tests, liver function, coagulation profile, immune function, and hemodynamics of the portal vein, proper hepatic artery, and splenic vein.Additionally, indocyanine green (ICG) clearance tests were performed at 3, 6, and 12 months to assess liver function.
Interventions
- Procedure Laparoscopic Partial Splenectomy
The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.
Primary outcome measures
- Change in Humoral Immune Markers from Baseline to 6 Months Postoperation [Time frame: Baseline (preoperative) and 6 months postoperation]
- Platelet Count at 6 Months Postoperation [Time frame: 6 months postoperation]
- White Blood Cell Count at 6 Months Postoperation [Time frame: 6 months postoperation]
- Hemoglobin Level at 6 Months Postoperation [Time frame: 6 months postoperation]
- Blood Flow Velocity of the Portal Vein at 6 Months Postoperation [Time frame: 6 months postoperation]
- Vascular Diameter of the Portal Vein at 6 Months Postoperation [Time frame: 6 months postoperation]
- Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation [Time frame: 6 months postoperation]
- Vascular Diameter of the Splenic Vein at 6 Months Postoperation [Time frame: 6 months postoperation]
- Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation [Time frame: 6 months postoperation]
- Incidence of Portal Venous System Thrombosis within 6 Months Postoperation [Time frame: 6 months postoperation]
Secondary outcome measures (12)
- Comparison of Humoral Immune Marker Levels at 7 Days Postoperation [Time frame: 7 days postoperation]
- Comparison of Humoral Immune Marker Levels at 3 months Postoperation [Time frame: 3 months postoperation]
- Platelet Count at 3 Months Postoperation [Time frame: 3 months postoperation]
- Platelet Count at 12 Months Postoperation [Time frame: 12 months postoperation]
- Platelet Count at 1 Month Postoperation [Time frame: 1 month postoperation]
- Comparison of Humoral Immune Marker Levels at 1 Month Postoperation [Time frame: 1 month postoperation]
- Comparison of Humoral Immune Marker Levels at 12 Months Postoperation [Time frame: 12 Months postoperation]
- White Blood Cell Count at 1 Month Postoperation [Time frame: 1 month postoperation]
- White Blood Cell Count at 3 Months Postoperation [Time frame: 3 months postoperation]
- White Blood Cell Count at 12 Months Postoperation [Time frame: 12 months postoperation]
- Hemoglobin Level at 1 Month Postoperation [Time frame: 1 month postoperation]
- Hemoglobin Level at 3 Months Postoperation [Time frame: 3 months postoperation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Clinical Medical College of Yangzhou University — Yangzhou
Identifiers
NCT: NCT07205471 · YZUC-014