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NCT Number: NCT05325424

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

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.

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Key information

Conditions

Cirrhosis, Liver Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Splenectomy; Status

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic splenectomy

Procedure

The laparoscopic splenectomy was performed by the same surgical team.

Primary outcomes

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 24 months

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 24 months

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

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 12 months

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

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

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Dou-Sheng Bai, MD

CONTACT

[email protected]

+8651487373372

Guo-Qing Jiang, MD

CONTACT

[email protected]

+8651487373272

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Acronym: ELSL

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2022
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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