NCT05339269

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

April 12, 2022

Last Update Submit

March 17, 2025

Conditions

Cirrhosis, LiverSplenectomy; Status

Keywords

CirrhosisSplenectomyLaparoscopyImmune function

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

EXPERIMENTAL

The laparoscopic splenectomy is performed by the same surgical team.

Procedure: Laparoscopic splenectomy

Interventions

Laparoscopic splenectomyPROCEDURE

The laparoscopic splenectomy is performed by the same surgical team.

Laparoscopic splenectomy

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, Platelet count \< 50\*10\^9/L
  • 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
  • Bleeding portal 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

Location

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 of Yangzhou University

    STUDY CHAIR

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 12, 2022

First Posted

April 21, 2022

Study Start

March 1, 2022

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

CN(1)