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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 12, 2022
First Posted Date  ICMJE April 21, 2022
Last Update Posted Date December 21, 2023
Actual Study Start Date  ICMJE March 1, 2022
Estimated Primary Completion Date October 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2022)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Laparoscopic Splenectomy on the Immune Function for Cirrhosis Patients
Official Title  ICMJE The Effect of Laparoscopic Splenectomy on the Immune Function for Cirrhosis Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cirrhosis, Liver
  • Splenectomy; Status
Intervention  ICMJE Procedure: Laparoscopic splenectomy
The laparoscopic splenectomy is performed by the same surgical team.
Study Arms  ICMJE Experimental: Laparoscopic splenectomy
The laparoscopic splenectomy is performed by the same surgical team.
Intervention: Procedure: Laparoscopic splenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2022)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2024
Estimated Primary Completion Date October 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guo-Qing Jiang, MD +8651487373382 jgqing2003@hotmail.com
Contact: Dou-Sheng Bai, MD +8651487373372 bdsno1@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05339269
Other Study ID Numbers  ICMJE YZUC-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Guo-Qing Jiang, Northern Jiangsu People's Hospital
Original Responsible Party Guo-Qing Jiang, Yangzhou University, Clinical Professor
Current Study Sponsor  ICMJE Northern Jiangsu People's Hospital
Original Study Sponsor  ICMJE Yangzhou University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Guo-Qing Jiang, MD Clinical Medical College of Yangzhou University
PRS Account Northern Jiangsu People's Hospital
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP