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

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ClinicalTrials.gov Identifier: NCT05339269
Recruitment Status : Recruiting
First Posted : April 21, 2022
Last Update Posted : December 21, 2023
Sponsor:
Information provided by (Responsible Party):
Guo-Qing Jiang, Northern Jiangsu People's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Splenectomy; Status Procedure: Laparoscopic splenectomy Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Laparoscopic Splenectomy on the Immune Function for Cirrhosis Patients
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Laparoscopic splenectomy
The laparoscopic splenectomy is performed by the same surgical team.
 Procedure: Laparoscopic splenectomy
The laparoscopic splenectomy is performed by the same surgical team.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05339269


Contacts
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Contact: Guo-Qing Jiang, MD +8651487373382 jgqing2003@hotmail.com
Contact: Dou-Sheng Bai, MD +8651487373372 bdsno1@hotmail.com

Locations
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China, Jiangsu
Clinical Medical College, Yangzhou University Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Guo-Qing Jiang, MD    86-514-87373372    jgqing2003@hotmail.com   
Contact: Dou-Sheng Bai, MD    86-514-87373372    bdsno1@hotmail.com   
Principal Investigator: Guo-Qing Jiang, MD         
Sub-Investigator: Tian-Ming Gao, MD         
Sponsors and Collaborators
Northern Jiangsu People's Hospital
Investigators
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Study Chair: Guo-Qing Jiang, MD Clinical Medical College of Yangzhou University
More Information
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Responsible Party: Guo-Qing Jiang, Clinical Professor, Northern Jiangsu People's Hospital
ClinicalTrials.gov Identifier: NCT05339269    
Other Study ID Numbers: YZUC-010
First Posted: April 21, 2022    Key Record Dates
Last Update Posted: December 21, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guo-Qing Jiang, Northern Jiangsu People's Hospital:
Cirrhosis
Splenectomy
Laparoscopy
Immune function
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases