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

• Sponsor: Yangzhou University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05339269
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 32
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Mar 1, 2022
• Anticipated Primary Completion Date: Oct 31, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

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

Primary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The immune function CD8+ at 24 months after surgery [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 [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 [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 [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 [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 [3 months]

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

14. The immune function CD19 at 6 months after surgery [6 months]

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

15. The immune function CD19 at 12 months after surgery [12 months]

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

16. The immune function CD19 at 24 months after surgery [24 months]

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

17. The immune function CD20 at 3 months after surgery [3 months]

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

18. The immune function CD20 at 6 months after surgery [6 months]

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

19. The immune function CD20 at 12 months after surgery [12 months]

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

20. The immune function CD20 at 24 months after surgery [24 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Clinical Medical College, Yangzhou University	Yangzhou	Jiangsu	China	225001

Sponsors and Collaborators

• Yangzhou University

Investigators

• Study Chair: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guo-Qing Jiang, Clinical Professor, Yangzhou University
• ClinicalTrials.gov Identifier: NCT05339269
• Other Study ID Numbers: YZUC-010
• First Posted: Apr 21, 2022
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Guo-Qing Jiang, Clinical Professor, Yangzhou University: Cirrhosis; Splenectomy; Laparoscopy; Immune function
• Additional relevant MeSH terms: Liver Cirrhosis; Fibrosis

Study Results

No Results Posted as of Apr 21, 2022