NCT05325424

Brief Summary

In this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy. To determine whether surgical treatment can help enhance postoperative liver reserve 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
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 13, 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 30, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

March 18, 2022

Last Update Submit

May 26, 2025

Conditions

Cirrhosis, LiverSplenectomy; Status

Keywords

CirrhosisSplenectomyLiver Reserve FunctionLaparoscopy

Outcome Measures

Primary Outcomes (12)

  • Liver reserve function ICG-K level at 3 months after surgery

    The level of liver reserve function ICG-K level at 3 months after surgery.

    3 months

  • Liver reserve function ICG-K level at 6 months after surgery.

    The level of liver reserve function ICG-K level at 6 months after surgery.

    6 months

  • Liver reserve function ICG-K level at 12 months after surgery

    The level of liver reserve function ICG-K level at 12 months after surgery.

    12 months

  • Liver reserve function ICG-K level at 24 months after surgery.

    The level of liver reserve function ICG-K level at 24 months after surgery.

    24 months

  • Liver reserve function ICG-R15 level at 3 months after surgery.

    The level of liver reserve function ICG-R15 level at 3 months after surgery.

    3 months

  • Liver reserve function ICG-R15 level at 6 months after surgery.

    The level of liver reserve function ICG-R15 level at 6 months after surgery.

    6 months

  • Liver reserve function ICG-R15 level at 12 months after surgery.

    The level of liver reserve function ICG-R15 level at 12 months after surgery.

    12 months

  • Liver reserve function ICG-R15 level at 24 months after surgery.

    The level of liver reserve function ICG-R15 level at 24 months after surgery.

    24 months

  • Liver reserve function ICG-T/2 level at 3 months after surgery.

    The level of liver reserve function ICG-T/2 level at 3 months after surgery.

    3 months

  • Liver reserve function ICG-T/2 level at 6 months after surgery.

    The level of liver reserve function ICG-T/2 level at 6 months after surgery.

    6 months

  • Liver reserve function ICG-T/2 level at 12 months after surgery.

    The level of liver reserve function ICG-T/2 level at 12 months after surgery.

    12 months

  • Liver reserve function ICG-T/2 level at 24 months after surgery.

    The level of liver reserve function ICG-T/2 level at 24 months after surgery.

    24 months

Study Arms (1)

Experimental Group

OTHER

Laparoscopic splenectomy

Procedure: Laparoscopic splenectomy

Interventions

Laparoscopic splenectomyPROCEDURE

The laparoscopic splenectomy was performed by the same surgical team.

Experimental Group

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 of 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 of Yangzhou University

    STUDY CHAIR

Central Study Contacts

Guo-Qing Jiang, MD

CONTACT

+8651487373272jgqing2003@hotmail.com

Dou-Sheng Bai, MD

CONTACT

+8651487373372bdsno1@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

March 18, 2022

First Posted

April 13, 2022

Study Start

March 1, 2022

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations

CN(1)