NCT05338294

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

April 13, 2022

Last Update Submit

May 26, 2025

Conditions

Cirrhosis, LiverSplenectomy; Status

Keywords

CirrhosisSplenectomyLaparoscopyImmune functionAzygoportal disconnection

Outcome Measures

Primary Outcomes (20)

  • The immune function CD4+ at 3 months after surgery

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

    3 months

  • The immune function CD4+ at 6 months after surgery

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

    6 months

  • The immune function CD4+ at 12 months after surgery

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

    12 months

  • The immune function CD4+ at 24 months after surgery

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

    24 months

  • The immune function CD8+ at 3 months after surgery

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

    3 months

  • The immune function CD8+ at 6 months after surgery

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

    6 months

  • The immune function CD8+ at 12 months after surgery

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

    12 months

  • The immune function CD8+ at 24 months after surgery

    The level of the immune function CD8+ at 24 months after surgery

    24 months

  • The immune function CD4+/CD8+ at 3 months after surgery

    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

    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

    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

    The level of the immune function CD4+/CD8+ at 24 months after surgery

    24 months

  • The immune function CD19 at 3 months after surgery

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

    3 months

  • The immune function CD19 at 6 months after surgery

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

    6 months

  • The immune function CD19 at 12 months after surgery

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

    12 months

  • The immune function CD19 at 24 months after surgery

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

    24 months

  • The immune function CD20 at 3 months after surgery

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

    3 months

  • The immune function CD20 at 6 months after surgery

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

    6 months

  • The immune function CD20 at 12 months after surgery

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

    12 months

  • The immune function CD20 at 24 months after surgery

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

    24 months

Study Arms (1)

Laparoscopic splenectomy and azygoportal disconnection

EXPERIMENTAL

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

Procedure: Laparoscopic splenectomy and azygoportal disconnection

Interventions

Laparoscopic splenectomy and azygoportal disconnectionPROCEDURE

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

Laparoscopic splenectomy and azygoportal disconnection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, 225001, China

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guo-Qing Jiang, MD

    Clinical Medical College, Yangzhou University

    STUDY CHAIR

Central Study Contacts

Guo-Qing Jiang, MD

CONTACT

+8651487373382jgqing2003@hotmail.com

Dou-Sheng Bai, MD

CONTACT

+8651487373382jgqing2003@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 21, 2022

Study Start

March 1, 2022

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Locations

CN(1)