Cirrhosis, LiverELSINCT05339269
The Effect of Laparoscopic Splenectomy on the Immune Function for Cirrhosis Patients
A study testing Laparoscopic splenectomy in people with Cirrhosis, Liver and Splenectomy; Status, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver, Splenectomy; Status
- What is being tested?
- Laparoscopic splenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Medical College, Yangzhou University
Yangzhou, Jiangsu, 225001
About this study
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.
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 immune function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including the counts of leukocytes, neutrophils, lymphocytes, and monocytes, and the levels of CD4+, CD8+, CD4+/CD8+, and CD19, CD20.
- Conditions
- Cirrhosis, Liver, Splenectomy; Status
- Being tested
- Laparoscopic splenectomy
- Keywords
- Cirrhosis, Splenectomy, Laparoscopy, Immune function
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic splenectomyProcedure or surgery
The laparoscopic splenectomy is performed by the same surgical team.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic splenectomy | Experimental | The laparoscopic splenectomy is performed by the same surgical team. Receives: Procedure: Laparoscopic splenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The immune function CD4+ at 3 months after surgery
The level of the immune function CD4+ at 3 months after surgery
Measured: 3 months
The immune function CD4+ at 6 months after surgery
The level of the immune function CD4+ at 6 months after surgery
Measured: 6 months
The immune function CD4+ at 12 months after surgery
The level of the immune function CD4+ at 12 months after surgery
Measured: 12 months
The immune function CD4+ at 24 months after surgery
The level of the immune function CD4+ at 24 months after surgery
Measured: 24 months
The immune function CD8+ at 3 months after surgery
The level of the immune function CD8+ at 3 months after surgery
Measured: 3 months
The immune function CD8+ at 6 months after surgery
The level of the immune function CD8+ at 6 months after surgery
Measured: 6 months
The immune function CD8+ at 12 months after surgery
The level of the immune function CD8+ at 12 months after surgery
Measured: 12 months
The immune function CD8+ at 24 months after surgery
The level of the immune function CD8+ at 24 months after surgery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months
The immune function CD19 at 3 months after surgery
The level of the immune function CD19 at 3 months after surgery
Measured: 3 months
The immune function CD19 at 6 months after surgery
The level of the immune function CD19 at 6 months after surgery
Measured: 6 months
The immune function CD19 at 12 months after surgery
The level of the immune function CD19 at 12 months after surgery
Measured: 12 months
The immune function CD19 at 24 months after surgery
The level of the immune function CD19 at 24 months after surgery
Measured: 24 months
The immune function CD20 at 3 months after surgery
The level of the immune function CD20 at 3 months after surgery
Measured: 3 months
The immune function CD20 at 6 months after surgery
The level of the immune function CD20 at 6 months after surgery
Measured: 6 months
The immune function CD20 at 12 months after surgery
The level of the immune function CD20 at 12 months after surgery
Measured: 12 months
The immune function CD20 at 24 months after surgery
The level of the immune function CD20 at 24 months after surgery
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Mar 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
- Investigators
- Guo-Qing Jiang, MD, Study chair, Clinical Medical College of Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339269
- Sponsor's protocol ID
- YZUC-010
- Acronym
- ELSI
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laparoscopic Splenectomy on the Immune Function for Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT05339269
- Acronym / sponsor ID
- ELSI / YZUC-010
- Conditions
- Cirrhosis, Liver, Splenectomy; Status
- Keywords
- Cirrhosis, Splenectomy, Laparoscopy, Immune function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 immune function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including the counts of leukocytes, neutrophils, lymphocytes, and monocytes, and the levels of CD4+, CD8+, CD4+/CD8+, and CD19, CD20.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic splenectomy | Experimental | Procedure: Laparoscopic splenectomyThe laparoscopic splenectomy is performed by the same surgical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Hepatocellular carcinoma or any other malignancy,
- Child-Pugh grade C
- Recent peptic ulcer disease
- History of Hemorrhagic stroke
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic splenectomyThe laparoscopic splenectomy is performed by the same surgical team. | Procedure or surgery | Laparoscopic splenectomy |
Primary outcome
The immune function CD4+ at 3 months after surgery
Time frame: 3 months
The level of the immune function CD4+ at 3 months after surgery
The immune function CD4+ at 6 months after surgery
Time frame: 6 months
The level of the immune function CD4+ at 6 months after surgery
The immune function CD4+ at 12 months after surgery
Time frame: 12 months
The level of the immune function CD4+ at 12 months after surgery
The immune function CD4+ at 24 months after surgery
Time frame: 24 months
The level of the immune function CD4+ at 24 months after surgery
The immune function CD8+ at 3 months after surgery
Time frame: 3 months
The level of the immune function CD8+ at 3 months after surgery
The immune function CD8+ at 6 months after surgery
Time frame: 6 months
The level of the immune function CD8+ at 6 months after surgery
The immune function CD8+ at 12 months after surgery
Time frame: 12 months
The level of the immune function CD8+ at 12 months after surgery
The immune function CD8+ at 24 months after surgery
Time frame: 24 months
The level of the immune function CD8+ at 24 months after surgery
The immune function CD4+/CD8+ at 3 months after surgery
Time frame: 3 months
The level of the immune function CD4+/CD8+ at 3 months after surgery
The immune function CD4+/CD8+ at 6 months after surgery
Time frame: 6 months
The level of the immune function CD4+/CD8+ at 6 months after surgery
The immune function CD4+/CD8+ at 12 months after surgery
Time frame: 12 months
The level of the immune function CD4+/CD8+ at 12 months after surgery
The immune function CD4+/CD8+ at 24 months after surgery
Time frame: 24 months
The level of the immune function CD4+/CD8+ at 24 months after surgery
The immune function CD19 at 3 months after surgery
Time frame: 3 months
The level of the immune function CD19 at 3 months after surgery
The immune function CD19 at 6 months after surgery
Time frame: 6 months
The level of the immune function CD19 at 6 months after surgery
The immune function CD19 at 12 months after surgery
Time frame: 12 months
The level of the immune function CD19 at 12 months after surgery
The immune function CD19 at 24 months after surgery
Time frame: 24 months
The level of the immune function CD19 at 24 months after surgery
The immune function CD20 at 3 months after surgery
Time frame: 3 months
The level of the immune function CD20 at 3 months after surgery
The immune function CD20 at 6 months after surgery
Time frame: 6 months
The level of the immune function CD20 at 6 months after surgery
The immune function CD20 at 12 months after surgery
Time frame: 12 months
The level of the immune function CD20 at 12 months after surgery
The immune function CD20 at 24 months after surgery
Time frame: 24 months
The level of the immune function CD20 at 24 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo-Qing Jiang, MD study chair
Clinical Medical College of Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic splenectomy in people with Cirrhosis, Liver and Splenectomy; Status, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The immune function CD4+ at 3 months after surgery (time frame: 3 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.