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RecruitingNCT05325424ELSLUpdated May 30, 2025

The Effect of Laparoscopic Splenectomy on Liver Reserve Function for Cirrhosis Patients

An interventional study of Laparoscopic splenectomy in Cirrhosis, Liver and Splenectomy; Status, sponsored by Northern Jiangsu People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Northern Jiangsu People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 liver reserve function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including TBIL, DBIL, ALB, ALT, INR, PT, Child-Pugh, ascites, prealbumin, ICG-K, ICG-R 15 and ICG-T/2.

02

Conditions studied

  • Cirrhosis, Liver
  • Splenectomy; Status

Keywords

  • Cirrhosis
  • Splenectomy
  • Liver Reserve Function
  • Laparoscopy
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Northern Jiangsu People's Hospital is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Experimental Group

    Laparoscopic splenectomy

    Procedure: Laparoscopic splenectomy

Interventions

  • ProcedureLaparoscopic splenectomy

    The laparoscopic splenectomy was performed by the same surgical team.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 12 months

  4. 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.

    Time frame: 24 months

  5. 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.

    Time frame: 3 months

  6. 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.

    Time frame: 6 months

  7. 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.

    Time frame: 12 months

  8. 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.

    Time frame: 24 months

  9. 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.

    Time frame: 3 months

  10. 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.

    Time frame: 6 months

  11. 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.

    Time frame: 12 months

  12. 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.

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Clinical Medical College of Yangzhou University
    Yangzhou, Jiangsu 225001, China
    • Guo-Qing Jiang, MD · Contact · jgqing2003@hotmail.com · 86-514-87373372
    • Dou-Sheng Bai, MD · Contact · bdsno1@hotmail.com · 86-514-87373372
    • Guo-Qing Jiang, MD · Principal investigator
    • Tian-Ming Gao, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05325424
Lead sponsor
Northern Jiangsu People's Hospital
Responsible party
Guo-Qing Jiang (Clinical Professor, Northern Jiangsu People's Hospital) — Principal investigator
First posted
Apr 13, 2022
Start date
Mar 1, 2022
Primary completion
Jul 31, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
May 30, 2025

Study contacts

Guo-Qing Jiang, MD
Contact
jgqing2003@hotmail.com
+8651487373272
Dou-Sheng Bai, MD
Contact
bdsno1@hotmail.com
+8651487373372
Guo-Qing Jiang, MD
study chair · Clinical Medical College of Yangzhou University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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