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Completed

NCT Number: NCT05339269

The Effect of Laparoscopic Splenectomy on the Immune Function for Cirrhosis Patients

In this study, the investigators compared the improvement of and azygoportal disconnection related indicators in patients with liver cirrhosis after laparoscopic splenectomy. To determine whether surgical treatment can help enhance postoperative immune function and improve patient prognosis.

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Key information

Conditions

Cirrhosis, Liver Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases 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

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

About this study

The patients were enrolled according to the research criteria, and collected the general basic information of the patients. After the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy, and the same nursing team performed the nursing after the operation. Then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. During the treatment, the immune function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including the counts of leukocytes, neutrophils, lymphocytes, and monocytes, and the levels of CD4+, CD8+, CD4+/CD8+, and CD19, CD20.

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, Platelet count < 50*10^9/L
  • 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
  • Bleeding portal hypertension
  • Human immunodeficiency virus (HIV) infection

Treatment and study plan

Laparoscopic splenectomy

Procedure

The laparoscopic splenectomy is performed by the same surgical team.

Primary outcomes

  1. The immune function CD4+ at 3 months after surgery

    Time frame: 3 months

    The level of the immune function CD4+ at 3 months after surgery

  2. The immune function CD4+ at 6 months after surgery

    Time frame: 6 months

    The level of the immune function CD4+ at 6 months after surgery

  3. The immune function CD4+ at 12 months after surgery

    Time frame: 12 months

    The level of the immune function CD4+ at 12 months after surgery

  4. The immune function CD4+ at 24 months after surgery

    Time frame: 24 months

    The level of the immune function CD4+ at 24 months after surgery

  5. The immune function CD8+ at 3 months after surgery

    Time frame: 3 months

    The level of the immune function CD8+ at 3 months after surgery

  6. The immune function CD8+ at 6 months after surgery

    Time frame: 6 months

    The level of the immune function CD8+ at 6 months after surgery

  7. The immune function CD8+ at 12 months after surgery

    Time frame: 12 months

    The level of the immune function CD8+ at 12 months after surgery

  8. The immune function CD8+ at 24 months after surgery

    Time frame: 24 months

    The level of the immune function CD8+ at 24 months after surgery

  9. The immune function CD4+/CD8+ at 3 months after surgery

    Time frame: 3 months

    The level of the immune function CD4+/CD8+ at 3 months after surgery

  10. The immune function CD4+/CD8+ at 6 months after surgery

    Time frame: 6 months

    The level of the immune function CD4+/CD8+ at 6 months after surgery

  11. The immune function CD4+/CD8+ at 12 months after surgery

    Time frame: 12 months

    The level of the immune function CD4+/CD8+ at 12 months after surgery

  12. The immune function CD4+/CD8+ at 24 months after surgery

    Time frame: 24 months

    The level of the immune function CD4+/CD8+ at 24 months after surgery

  13. The immune function CD19 at 3 months after surgery

    Time frame: 3 months

    The level of the immune function CD19 at 3 months after surgery

  14. The immune function CD19 at 6 months after surgery

    Time frame: 6 months

    The level of the immune function CD19 at 6 months after surgery

  15. The immune function CD19 at 12 months after surgery

    Time frame: 12 months

    The level of the immune function CD19 at 12 months after surgery

  16. The immune function CD19 at 24 months after surgery

    Time frame: 24 months

    The level of the immune function CD19 at 24 months after surgery

  17. The immune function CD20 at 3 months after surgery

    Time frame: 3 months

    The level of the immune function CD20 at 3 months after surgery

  18. The immune function CD20 at 6 months after surgery

    Time frame: 6 months

    The level of the immune function CD20 at 6 months after surgery

  19. The immune function CD20 at 12 months after surgery

    Time frame: 12 months

    The level of the immune function CD20 at 12 months after surgery

  20. The immune function CD20 at 24 months after surgery

    Time frame: 24 months

    The level of the immune function CD20 at 24 months after surgery

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Acronym: ELSI

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2022
Registry last updated
Mar 19, 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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