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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, China
RECRUITINGChange in Humoral Immune Markers from Baseline to 6 Months Postoperation
Serum levels of immunoglobulins (IgG, IgA, IgM), complement proteins (C3, C4), and B-cell markers (CD19, CD20) will be measured. The primary outcome is the change in these markers from preoperative baseline to 6 months after surgery.
Time frame: Baseline (preoperative) and 6 months postoperation
Platelet Count at 6 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Time frame: 6 months postoperation
White Blood Cell Count at 6 Months Postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Time frame: 6 months postoperation
Hemoglobin Level at 6 Months Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Time frame: 6 months postoperation
Blood Flow Velocity of the Portal Vein at 6 Months Postoperation
Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 6 months postoperation
Vascular Diameter of the Portal Vein at 6 Months Postoperation
Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 6 months postoperation
Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation
Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 6 months postoperation
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Vascular Diameter of the Splenic Vein at 6 Months Postoperation
Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 6 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Time frame: 6 months postoperation
Incidence of Portal Venous System Thrombosis within 6 Months Postoperation
The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared.
Time frame: 6 months postoperation
Comparison of Humoral Immune Marker Levels at 7 Days Postoperation
Serum levels of key humoral immune markers (including but not limited to IgG, IgA, IgM, C3, C4, CD19, CD20) will be compared between the laparoscopic partial splenectomy group and the total splenectomy group at 7 days after surgery.
Time frame: 7 days postoperation
Comparison of Humoral Immune Marker Levels at 3 months Postoperation
Serum levels of key humoral immune markers (IgG, IgA, IgM, C3, C4, CD19, CD20) will be compared between the two groups at this time point
Time frame: 3 months postoperation
Platelet Count at 3 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Time frame: 3 months postoperation
Platelet Count at 12 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Time frame: 12 months postoperation
Platelet Count at 1 Month Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Time frame: 1 month postoperation
Comparison of Humoral Immune Marker Levels at 1 Month Postoperation
Serum levels of key humoral immune markers (IgG, IgA, IgM, C3, C4, CD19, CD20) will be compared between the two groups at this time point.
Time frame: 1 month postoperation
Comparison of Humoral Immune Marker Levels at 12 Months Postoperation
Serum levels of key cellular immune markers (CD4, CD16, CD56, CD35) will be compared between the two groups at this time point.
Time frame: 12 Months postoperation
White Blood Cell Count at 1 Month Postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Time frame: 1 month postoperation
White Blood Cell Count at 3 Months Postoperation
White blood cell count (×10⁹/L) will be compared between groups
Time frame: 3 months postoperation
White Blood Cell Count at 12 Months Postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Time frame: 12 months postoperation
Hemoglobin Level at 1 Month Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Time frame: 1 month postoperation
Hemoglobin Level at 3 Months Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Time frame: 3 months postoperation
Hemoglobin Level at 12 Months Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Time frame: 12 months postoperation
Blood Flow Velocity of the Portal Vein at 3 Months Postoperation
Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 3 months postoperation
Blood Flow Velocity of the Portal Vein at 12 Months Postoperation
Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 12 months postoperation
Vascular Diameter of the Portal Vein at 3 Months Postoperation
Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 3 months postoperation
Vascular Diameter of the Portal Vein at 12 Months Postoperation
Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 12 months postoperation
Blood Flow Velocity of the Splenic Vein at 3 Months Postoperation
Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 3 months postoperation
Blood Flow Velocity of the Splenic Vein at 12 Months Postoperation
Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 12 months postoperation
Vascular Diameter of the Splenic Vein at 3 Months Postoperation
Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 3 months postoperation
Vascular Diameter of the Splenic Vein at 12 Months Postoperation
Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Time frame: 12 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 3 Months Postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Time frame: 3 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 9 Months Postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Time frame: 9 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 12 Months Postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Time frame: 12 months postoperation
Incidence of Portal Venous System Thrombosis within 12 Months Postoperation
The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared.
Time frame: 12 months postoperation
Incidence of Postoperative Complications within 30 Days
The number of participants experiencing complications (e.g., bleeding, infection, pancreatic fistula) will be compared using the Clavien-Dindo classification or similar.
Time frame: 30 days postoperation