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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic splenectomy | No Intervention | Patients in this arm undergo the standard laparoscopic splenectomy procedure, which serves as the active comparator. The entire spleen is removed after careful dissection and ligation of the splenic hilum. | |
| laparoscopic partial splenectomy | Experimental | The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Partial Splenectomy | Procedure | The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line. |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | 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. | 6 months postoperation |
| White Blood Cell Count at 6 Months Postoperation | White blood cell count (×10⁹/L) will be compared between groups. | 6 months postoperation |
| Hemoglobin Level at 6 Months Postoperation | Hemoglobin concentration (g/L) will be compared between groups. | 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. | 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. | 6 months postoperation |
| Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days postoperation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo-Qing Jiang | Contact | +8651487373382 | jgqing2003@hotmail.com | |
| Dou-Sheng Bai | Contact | +8651487373382 | jgqing2003@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guo-Qing Jiang | Clinical Medical College, Yangzhou University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Medical College of Yangzhou University | Recruiting | Yangzhou | Jiangsu | 225001 | China |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
| 6 months postoperation |
| 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. | 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. | 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. | 6 months 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 |
| 3 months postoperation |
| Platelet Count at 3 Months Postoperation | Platelet count (×10⁹/L) will be measured and compared between the two surgical groups. | 3 months postoperation |
| Platelet Count at 12 Months Postoperation | Platelet count (×10⁹/L) will be measured and compared between the two surgical groups. | 12 months postoperation |
| Platelet Count at 1 Month Postoperation | Platelet count (×10⁹/L) will be measured and compared between the two surgical groups. | 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. | 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. | 12 Months postoperation |
| White Blood Cell Count at 1 Month Postoperation | White blood cell count (×10⁹/L) will be compared between groups. | 1 month postoperation |
| White Blood Cell Count at 3 Months Postoperation | White blood cell count (×10⁹/L) will be compared between groups | 3 months postoperation |
| White Blood Cell Count at 12 Months Postoperation | White blood cell count (×10⁹/L) will be compared between groups. | 12 months postoperation |
| Hemoglobin Level at 1 Month Postoperation | Hemoglobin concentration (g/L) will be compared between groups. | 1 month postoperation |
| Hemoglobin Level at 3 Months Postoperation | Hemoglobin concentration (g/L) will be compared between groups. | 3 months postoperation |
| Hemoglobin Level at 12 Months Postoperation | Hemoglobin concentration (g/L) will be compared between groups. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 30 days postoperation |