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

December 15, 2023 updated by: Guo-Qing Jiang, Northern Jiangsu People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Clinical Medical College, Yangzhou University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guo-Qing Jiang, MD
        • Sub-Investigator:
          • Tian-Ming Gao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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
6 months
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
12 months
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
24 months
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
3 months
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
6 months
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
12 months
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
24 months
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
3 months
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
6 months
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 months
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
24 months
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
3 months
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
6 months
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
12 months
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
24 months
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
3 months
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
6 months
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
12 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Jiangsu People's Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZUC-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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