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The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients (ELSDI)

Primary Purpose

Cirrhosis, Liver, Splenectomy; Status

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic splenectomy and azygoportal disconnection
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Cirrhosis, Splenectomy, Laparoscopy, Immune function, Azygoportal disconnection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Medical College, Yangzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopic splenectomy and azygoportal disconnection

Arm Description

Laparoscopic splenectomy and azygoportal disconnection was performed by the same surgical team.

Outcomes

Primary Outcome Measures

The immune function CD4+ at 3 months after surgery
The level of the immune function CD4+ at 3 months after surgery
The immune function CD4+ at 6 months after surgery
The level of the immune function CD4+ at 6 months after surgery
The immune function CD4+ at 12 months after surgery
The level of the immune function CD4+ at 12 months after surgery
The immune function CD4+ at 24 months after surgery
The level of the immune function CD4+ at 24 months after surgery
The immune function CD8+ at 3 months after surgery
The level of the immune function CD8+ at 3 months after surgery
The immune function CD8+ at 6 months after surgery
The level of the immune function CD8+ at 6 months after surgery
The immune function CD8+ at 12 months after surgery
The level of the immune function CD8+ at 12 months after surgery
The immune function CD8+ at 24 months after surgery
The level of the immune function CD8+ at 24 months after surgery
The immune function CD4+/CD8+ at 3 months after surgery
The level of the immune function CD4+/CD8+ at 3 months after surgery
The immune function CD4+/CD8+ at 6 months after surgery
The level of the immune function CD4+/CD8+ at 6 months after surgery
The immune function CD4+/CD8+ at 12 months after surgery
The level of the immune function CD4+/CD8+ at 12 months after surgery
The immune function CD4+/CD8+ at 24 months after surgery
The level of the immune function CD4+/CD8+ at 24 months after surgery
The immune function CD19 at 3 months after surgery
The level of the immune function CD19 at 3 months after surgery
The immune function CD19 at 6 months after surgery
The level of the immune function CD19 at 6 months after surgery
The immune function CD19 at 12 months after surgery
The level of the immune function CD19 at 12 months after surgery
The immune function CD19 at 24 months after surgery
The level of the immune function CD19 at 24 months after surgery
The immune function CD20 at 3 months after surgery
The level of the immune function CD20 at 3 months after surgery
The immune function CD20 at 6 months after surgery
The level of the immune function CD20 at 6 months after surgery
The immune function CD20 at 12 months after surgery
The level of the immune function CD20 at 12 months after surgery
The immune function CD20 at 24 months after surgery
The level of the immune function CD20 at 24 months after surgery

Secondary Outcome Measures

Full Information

First Posted
April 13, 2022
Last Updated
July 23, 2023
Sponsor
Yangzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT05338294
Brief Title
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients
Acronym
ELSDI
Official Title
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Splenectomy; Status
Keywords
Cirrhosis, Splenectomy, Laparoscopy, Immune function, Azygoportal disconnection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic splenectomy and azygoportal disconnection
Arm Type
Experimental
Arm Description
Laparoscopic splenectomy and azygoportal disconnection was performed by the same surgical team.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic splenectomy and azygoportal disconnection
Intervention Description
Laparoscopic splenectomy and azygoportal disconnection is performed by the same surgical team.
Primary Outcome Measure Information:
Title
The immune function CD4+ at 3 months after surgery
Description
The level of the immune function CD4+ at 3 months after surgery
Time Frame
3 months
Title
The immune function CD4+ at 6 months after surgery
Description
The level of the immune function CD4+ at 6 months after surgery
Time Frame
6 months
Title
The immune function CD4+ at 12 months after surgery
Description
The level of the immune function CD4+ at 12 months after surgery
Time Frame
12 months
Title
The immune function CD4+ at 24 months after surgery
Description
The level of the immune function CD4+ at 24 months after surgery
Time Frame
24 months
Title
The immune function CD8+ at 3 months after surgery
Description
The level of the immune function CD8+ at 3 months after surgery
Time Frame
3 months
Title
The immune function CD8+ at 6 months after surgery
Description
The level of the immune function CD8+ at 6 months after surgery
Time Frame
6 months
Title
The immune function CD8+ at 12 months after surgery
Description
The level of the immune function CD8+ at 12 months after surgery
Time Frame
12 months
Title
The immune function CD8+ at 24 months after surgery
Description
The level of the immune function CD8+ at 24 months after surgery
Time Frame
24 months
Title
The immune function CD4+/CD8+ at 3 months after surgery
Description
The level of the immune function CD4+/CD8+ at 3 months after surgery
Time Frame
3 months
Title
The immune function CD4+/CD8+ at 6 months after surgery
Description
The level of the immune function CD4+/CD8+ at 6 months after surgery
Time Frame
6 months
Title
The immune function CD4+/CD8+ at 12 months after surgery
Description
The level of the immune function CD4+/CD8+ at 12 months after surgery
Time Frame
12 months
Title
The immune function CD4+/CD8+ at 24 months after surgery
Description
The level of the immune function CD4+/CD8+ at 24 months after surgery
Time Frame
24 months
Title
The immune function CD19 at 3 months after surgery
Description
The level of the immune function CD19 at 3 months after surgery
Time Frame
3 months
Title
The immune function CD19 at 6 months after surgery
Description
The level of the immune function CD19 at 6 months after surgery
Time Frame
6 months
Title
The immune function CD19 at 12 months after surgery
Description
The level of the immune function CD19 at 12 months after surgery
Time Frame
12 months
Title
The immune function CD19 at 24 months after surgery
Description
The level of the immune function CD19 at 24 months after surgery
Time Frame
24 months
Title
The immune function CD20 at 3 months after surgery
Description
The level of the immune function CD20 at 3 months after surgery
Time Frame
3 months
Title
The immune function CD20 at 6 months after surgery
Description
The level of the immune function CD20 at 6 months after surgery
Time Frame
6 months
Title
The immune function CD20 at 12 months after surgery
Description
The level of the immune function CD20 at 12 months after surgery
Time Frame
12 months
Title
The immune function CD20 at 24 months after surgery
Description
The level of the immune function CD20 at 24 months after surgery
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-Qing Jiang, MD
Phone
+8651487373382
Email
jgqing2003@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dou-Sheng Bai, MD
Phone
+8651487373382
Email
jgqing2003@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
Organizational Affiliation
Clinical Medical College, Yangzhou University
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Medical College, Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
Phone
86-514-87373372
Email
jgqing2003@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dou-Sheng Bai, MD
Phone
86-514-87373372
Email
bdsno1@hotmail.com
First Name & Middle Initial & Last Name & Degree
Guo-Qing Jiang, MD
First Name & Middle Initial & Last Name & Degree
Tian-Ming Gao, MD

12. IPD Sharing Statement

Learn more about this trial

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

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