Cirrhoses, Liver, Partial, Splenectomy; Status
Conditions
Keywords
Cirrhosis, Splenectomy, Laparoscopy, immune function, partial
Brief summary
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
PROCEDURELaparoscopic 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.
Sponsors
Northern Jiangsu People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Humoral Immune Markers from Baseline to 6 Months Postoperation | Baseline (preoperative) and 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. |
| Platelet Count at 6 Months Postoperation | 6 months postoperation | Platelet count (×10⁹/L) will be measured and compared between the two surgical groups. |
| White Blood Cell Count at 6 Months Postoperation | 6 months postoperation | White blood cell count (×10⁹/L) will be compared between groups. |
| Hemoglobin Level at 6 Months Postoperation | 6 months postoperation | Hemoglobin concentration (g/L) will be compared between groups. |
| Blood Flow Velocity of the Portal Vein at 6 Months Postoperation | 6 months postoperation | Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups. |
| Vascular Diameter of the Portal Vein at 6 Months Postoperation | 6 months postoperation | Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups. |
| Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation | 6 months postoperation | Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups. |
| Vascular Diameter of the Splenic Vein at 6 Months Postoperation | 6 months postoperation | Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups. |
| Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation | 6 months postoperation | Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups. |
| Incidence of Portal Venous System Thrombosis within 6 Months Postoperation | 6 months postoperation | The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Level at 1 Month Postoperation | 1 month postoperation | Hemoglobin concentration (g/L) will be compared between groups. |
| Hemoglobin Level at 3 Months Postoperation | 3 months postoperation | Hemoglobin concentration (g/L) will be compared between groups. |
| Hemoglobin Level at 12 Months Postoperation | 12 months postoperation | Hemoglobin concentration (g/L) will be compared between groups. |
| Blood Flow Velocity of the Portal Vein at 3 Months Postoperation | 3 months postoperation | Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups. |
| Blood Flow Velocity of the Portal Vein at 12 Months Postoperation | 12 months postoperation | Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups. |
| Vascular Diameter of the Portal Vein at 3 Months Postoperation | 3 months postoperation | Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups. |
| Vascular Diameter of the Portal Vein at 12 Months Postoperation | 12 months postoperation | Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups. |
| Blood Flow Velocity of the Splenic Vein at 3 Months Postoperation | 3 months postoperation | Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups. |
| Comparison of Humoral Immune Marker Levels at 7 Days Postoperation | 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. |
| Vascular Diameter of the Splenic Vein at 3 Months Postoperation | 3 months postoperation | Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups. |
| Vascular Diameter of the Splenic Vein at 12 Months Postoperation | 12 months postoperation | Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups. |
| Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 3 Months Postoperation | 3 months postoperation | Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups. |
| Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 9 Months Postoperation | 9 months postoperation | Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups. |
| Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 12 Months Postoperation | 12 months postoperation | Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups. |
| Incidence of Portal Venous System Thrombosis within 12 Months Postoperation | 12 months postoperation | The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared. |
| Incidence of Postoperative Complications within 30 Days | 30 days postoperation | The number of participants experiencing complications (e.g., bleeding, infection, pancreatic fistula) will be compared using the Clavien-Dindo classification or similar. |
| Blood Flow Velocity of the Splenic Vein at 12 Months Postoperation | 12 months postoperation | Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups. |
| Comparison of Humoral Immune Marker Levels at 3 months Postoperation | 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 |
| Platelet Count at 3 Months Postoperation | 3 months postoperation | Platelet count (×10⁹/L) will be measured and compared between the two surgical groups. |
| Platelet Count at 12 Months Postoperation | 12 months postoperation | Platelet count (×10⁹/L) will be measured and compared between the two surgical groups. |
| Platelet Count at 1 Month Postoperation | 1 month postoperation | Platelet count (×10⁹/L) will be measured and compared between the two surgical groups. |
| Comparison of Humoral Immune Marker Levels at 1 Month Postoperation | 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. |
| Comparison of Humoral Immune Marker Levels at 12 Months Postoperation | 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. |
| White Blood Cell Count at 1 Month Postoperation | 1 month postoperation | White blood cell count (×10⁹/L) will be compared between groups. |
| White Blood Cell Count at 3 Months Postoperation | 3 months postoperation | White blood cell count (×10⁹/L) will be compared between groups |
| White Blood Cell Count at 12 Months Postoperation | 12 months postoperation | White blood cell count (×10⁹/L) will be compared between groups. |
Countries
China
Contacts
Primary ContactGuo-Qing Jiang
Backup ContactDou-Sheng Bai
Outcome results
None listed