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NCT Number: NCT07205471

Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients

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.

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Key information

Conditions

Cirrhoses, Liver Fibrosis Partial Pathologic Processes Pathological Conditions, Signs and Symptoms Splenectomy; Status

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Humoral Immune Markers from Baseline to 6 Months Postoperation

    Time frame: 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.

  2. Platelet Count at 6 Months Postoperation

    Time frame: 6 months postoperation

    Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.

  3. White Blood Cell Count at 6 Months Postoperation

    Time frame: 6 months postoperation

    White blood cell count (×10⁹/L) will be compared between groups.

  4. Hemoglobin Level at 6 Months Postoperation

    Time frame: 6 months postoperation

    Hemoglobin concentration (g/L) will be compared between groups.

  5. Blood Flow Velocity of the Portal Vein at 6 Months Postoperation

    Time frame: 6 months postoperation

    Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.

  6. Vascular Diameter of the Portal Vein at 6 Months Postoperation

    Time frame: 6 months postoperation

    Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.

  7. Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation

    Time frame: 6 months postoperation

    Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.

  8. Vascular Diameter of the Splenic Vein at 6 Months Postoperation

    Time frame: 6 months postoperation

    Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.

  9. Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation

    Time frame: 6 months postoperation

    Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.

  10. Incidence of Portal Venous System Thrombosis within 6 Months Postoperation

    Time frame: 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 outcomes

  1. Comparison of Humoral Immune Marker Levels at 7 Days Postoperation

    Time frame: 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.

  2. Comparison of Humoral Immune Marker Levels at 3 months Postoperation

    Time frame: 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. Platelet Count at 3 Months Postoperation

    Time frame: 3 months postoperation

    Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.

  4. Platelet Count at 12 Months Postoperation

    Time frame: 12 months postoperation

    Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.

  5. Platelet Count at 1 Month Postoperation

    Time frame: 1 month postoperation

    Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.

  6. Comparison of Humoral Immune Marker Levels at 1 Month Postoperation

    Time frame: 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.

  7. Comparison of Humoral Immune Marker Levels at 12 Months Postoperation

    Time frame: 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.

  8. White Blood Cell Count at 1 Month Postoperation

    Time frame: 1 month postoperation

    White blood cell count (×10⁹/L) will be compared between groups.

  9. White Blood Cell Count at 3 Months Postoperation

    Time frame: 3 months postoperation

    White blood cell count (×10⁹/L) will be compared between groups

  10. White Blood Cell Count at 12 Months Postoperation

    Time frame: 12 months postoperation

    White blood cell count (×10⁹/L) will be compared between groups.

  11. Hemoglobin Level at 1 Month Postoperation

    Time frame: 1 month postoperation

    Hemoglobin concentration (g/L) will be compared between groups.

  12. Hemoglobin Level at 3 Months Postoperation

    Time frame: 3 months postoperation

    Hemoglobin concentration (g/L) will be compared between groups.

  13. Hemoglobin Level at 12 Months Postoperation

    Time frame: 12 months postoperation

    Hemoglobin concentration (g/L) will be compared between groups.

  14. Blood Flow Velocity of the Portal Vein at 3 Months Postoperation

    Time frame: 3 months postoperation

    Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.

  15. Blood Flow Velocity of the Portal Vein at 12 Months Postoperation

    Time frame: 12 months postoperation

    Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.

  16. Vascular Diameter of the Portal Vein at 3 Months Postoperation

    Time frame: 3 months postoperation

    Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.

  17. Vascular Diameter of the Portal Vein at 12 Months Postoperation

    Time frame: 12 months postoperation

    Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.

  18. Blood Flow Velocity of the Splenic Vein at 3 Months Postoperation

    Time frame: 3 months postoperation

    Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.

  19. Blood Flow Velocity of the Splenic Vein at 12 Months Postoperation

    Time frame: 12 months postoperation

    Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.

  20. Vascular Diameter of the Splenic Vein at 3 Months Postoperation

    Time frame: 3 months postoperation

    Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.

  21. Vascular Diameter of the Splenic Vein at 12 Months Postoperation

    Time frame: 12 months postoperation

    Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.

  22. Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 3 Months Postoperation

    Time frame: 3 months postoperation

    Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.

  23. Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 9 Months Postoperation

    Time frame: 9 months postoperation

    Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.

  24. Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 12 Months Postoperation

    Time frame: 12 months postoperation

    Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.

  25. Incidence of Portal Venous System Thrombosis within 12 Months Postoperation

    Time frame: 12 months postoperation

    The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared.

  26. Incidence of Postoperative Complications within 30 Days

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dou-Sheng Bai

CONTACT

[email protected]

+8651487373382

Guo-Qing Jiang

CONTACT

[email protected]

+8651487373382

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients

Acronym: LPSH

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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