Cirrhoses, LiverLPSHNCT07205471
Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
A study testing Laparoscopic Partial Splenectomy in people with Cirrhoses, Liver and Splenectomy; Status, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
In this study,the researchers compared the changes in immune function-related indicators in patients with liver cirrhosis following laparoscopic partial splenectomy,to determine whether this surgical intervention can enhance postoperative immune function and thereby improve patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhoses, Liver, Splenectomy; Status, Partial
- What is being tested?
- Laparoscopic Partial Splenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2025to 24 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- gastroesophageal variceal bleeding
- 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
- Human immunodeficiency virus (HIV) infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001
Guo-Qing Jiang, MS, 86-514-87373372, jgqing2003@hotmail.com
Dou-Sheng Bai, MD, 86-514-87373375, bdsno1@hotmail.com
About this study
Official title: The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
In this study,the researchers compared the changes in immune function-related indicators in patients with liver cirrhosis following laparoscopic partial splenectomy,to determine whether this surgical intervention can enhance postoperative immune function and thereby improve patient outcomes.
Read the detailed description
Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Eligible patients were randomly assigned in a 1:1 ratio to two groups: the laparoscopic splenectomy group and the laparoscopic partial splenectomy group, using a computer-generated randomization sequence. Following comprehensive preoperative preparation, all surgeries were performed by the same surgical team. The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.
Postoperatively, all patients received standardized care from the same nursing team, followed by a uniform treatment protocol that included pharmacotherapy, additional therapeutic interventions, and follow-up assessments. Throughout the treatment period, monitoring was performed preoperatively and at 7 days, 1, 3, 6, and 12 months postoperatively. The parameters monitored included routine blood tests, liver function, coagulation profile, immune function, and hemodynamics of the portal vein, proper hepatic artery, and splenic vein.Additionally, indocyanine green (ICG) clearance tests were performed at 3, 6, and 12 months to assess liver function.
- Conditions
- Cirrhoses, Liver, Splenectomy; Status, Partial
- Being tested
- Laparoscopic Partial Splenectomy
- Keywords
- Cirrhosis, Splenectomy, Laparoscopy, immune function, partial
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Partial SplenectomyProcedure or surgery
The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic splenectomy | No intervention | Patients in this arm undergo the standard laparoscopic splenectomy procedure, which serves as the active comparator. The entire spleen is removed after careful dissection and ligation of the splenic hilum. |
| laparoscopic partial splenectomy | Experimental | The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line. Receives: Procedure: Laparoscopic Partial Splenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Humoral Immune Markers from Baseline to 6 Months Postoperation
Serum levels of immunoglobulins (IgG, IgA, IgM), complement proteins (C3, C4), and B-cell markers (CD19, CD20) will be measured. The primary outcome is the change in these markers from preoperative baseline to 6 months after surgery.
Measured: Baseline (preoperative) and 6 months postoperation
Platelet Count at 6 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Measured: 6 months postoperation
White Blood Cell Count at 6 Months Postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Measured: 6 months postoperation
Hemoglobin Level at 6 Months Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Measured: 6 months postoperation
Blood Flow Velocity of the Portal Vein at 6 Months Postoperation
Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 6 months postoperation
Vascular Diameter of the Portal Vein at 6 Months Postoperation
Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 6 months postoperation
Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation
Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 6 months postoperation
Vascular Diameter of the Splenic Vein at 6 Months Postoperation
Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 6 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Measured: 6 months postoperation
Incidence of Portal Venous System Thrombosis within 6 Months Postoperation
The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared.
Measured: 6 months postoperation
Secondary outcomes (26)
Comparison of Humoral Immune Marker Levels at 7 Days Postoperation
Serum levels of key humoral immune markers (including but not limited to IgG, IgA, IgM, C3, C4, CD19, CD20) will be compared between the laparoscopic partial splenectomy group and the total splenectomy group at 7 days after surgery.
Measured: 7 days postoperation
Comparison of Humoral Immune Marker Levels at 3 months Postoperation
Serum levels of key humoral immune markers (IgG, IgA, IgM, C3, C4, CD19, CD20) will be compared between the two groups at this time point
Measured: 3 months postoperation
Platelet Count at 3 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Measured: 3 months postoperation
Platelet Count at 12 Months Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Measured: 12 months postoperation
Platelet Count at 1 Month Postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
Measured: 1 month postoperation
Comparison of Humoral Immune Marker Levels at 1 Month Postoperation
Serum levels of key humoral immune markers (IgG, IgA, IgM, C3, C4, CD19, CD20) will be compared between the two groups at this time point.
Measured: 1 month postoperation
Comparison of Humoral Immune Marker Levels at 12 Months Postoperation
Serum levels of key cellular immune markers (CD4, CD16, CD56, CD35) will be compared between the two groups at this time point.
Measured: 12 Months postoperation
White Blood Cell Count at 1 Month Postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Measured: 1 month postoperation
White Blood Cell Count at 3 Months Postoperation
White blood cell count (×10⁹/L) will be compared between groups
Measured: 3 months postoperation
White Blood Cell Count at 12 Months Postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Measured: 12 months postoperation
Hemoglobin Level at 1 Month Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Measured: 1 month postoperation
Hemoglobin Level at 3 Months Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Measured: 3 months postoperation
Hemoglobin Level at 12 Months Postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Measured: 12 months postoperation
Blood Flow Velocity of the Portal Vein at 3 Months Postoperation
Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 3 months postoperation
Blood Flow Velocity of the Portal Vein at 12 Months Postoperation
Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 12 months postoperation
Vascular Diameter of the Portal Vein at 3 Months Postoperation
Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 3 months postoperation
Vascular Diameter of the Portal Vein at 12 Months Postoperation
Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 12 months postoperation
Blood Flow Velocity of the Splenic Vein at 3 Months Postoperation
Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 3 months postoperation
Blood Flow Velocity of the Splenic Vein at 12 Months Postoperation
Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 12 months postoperation
Vascular Diameter of the Splenic Vein at 3 Months Postoperation
Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 3 months postoperation
Vascular Diameter of the Splenic Vein at 12 Months Postoperation
Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Measured: 12 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 3 Months Postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Measured: 3 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 9 Months Postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Measured: 9 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 12 Months Postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Measured: 12 months postoperation
Incidence of Portal Venous System Thrombosis within 12 Months Postoperation
The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared.
Measured: 12 months postoperation
Incidence of Postoperative Complications within 30 Days
The number of participants experiencing complications (e.g., bleeding, infection, pancreatic fistula) will be compared using the Clavien-Dindo classification or similar.
Measured: 30 days postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start24 Sep 2025
- Primary completion24 Sep 2028 (estimated)
- Study completion24 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhoses, 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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, Study chair, Clinical Medical College, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205471
- Sponsor's protocol ID
- YZUC-014
- Acronym
- LPSH
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Laparoscopic Partial Splenectomy for Hypersplenism in Liver Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT07205471
- Acronym / sponsor ID
- LPSH / YZUC-014
- Conditions
- Cirrhoses, Liver, Splenectomy; Status, Partial
- Keywords
- Cirrhosis, Splenectomy, Laparoscopy, immune function, partial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 24 Sep 2028 (estimated)
- Study completion
- 24 Sep 2028 (estimated)
- First posted
- 3 Oct 2025 (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 researchers compared the changes in immune function-related indicators in patients with liver cirrhosis following laparoscopic partial splenectomy,to determine whether this surgical intervention can enhance postoperative immune function and thereby improve patient outcomes.
Detailed description
Patients meeting the study's inclusion criteria were enrolled, and their baseline demographic data were collected. Eligible patients were randomly assigned in a 1:1 ratio to two groups: the laparoscopic splenectomy group and the laparoscopic partial splenectomy group, using a computer-generated randomization sequence. Following comprehensive preoperative preparation, all surgeries were performed by the same surgical team. The laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line.
Postoperatively, all patients received standardized care from the same nursing team, followed by a uniform treatment protocol that included pharmacotherapy, additional therapeutic interventions, and follow-up assessments. Throughout the treatment period, monitoring was performed preoperatively and at 7 days, 1, 3, 6, and 12 months postoperatively. The parameters monitored included routine blood tests, liver function, coagulation profile, immune function, and hemodynamics of the portal vein, proper hepatic artery, and splenic vein.Additionally, indocyanine green (ICG) clearance tests were performed at 3, 6, and 12 months to assess liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic splenectomy | No intervention | –Patients in this arm undergo the standard laparoscopic splenectomy procedure, which serves as the active comparator. The entire spleen is removed after careful dissection and ligation of the splenic hilum. |
| laparoscopic partial splenectomy | Experimental | Procedure: Laparoscopic Partial SplenectomyThe laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- Splenomegaly with secondary hypersplenism
- gastroesophageal variceal bleeding
- Informed consent to participate in the study
Key exclusion criteria (7 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 Partial SplenectomyThe laparoscopic partial splenectomy technique involved preserving the short gastric vessels and the splenic suspensory ligament, with resection conducted along the demarcation line. | Procedure or surgery | laparoscopic partial splenectomy |
Primary outcome
Change in Humoral Immune Markers from Baseline to 6 Months Postoperation
Time frame: Baseline (preoperative) and 6 months postoperation
Serum levels of immunoglobulins (IgG, IgA, IgM), complement proteins (C3, C4), and B-cell markers (CD19, CD20) will be measured. The primary outcome is the change in these markers from preoperative baseline to 6 months after surgery.
Platelet Count at 6 Months Postoperation
Time frame: 6 months postoperation
Platelet count (×10⁹/L) will be measured and compared between the two surgical groups.
White Blood Cell Count at 6 Months Postoperation
Time frame: 6 months postoperation
White blood cell count (×10⁹/L) will be compared between groups.
Hemoglobin Level at 6 Months Postoperation
Time frame: 6 months postoperation
Hemoglobin concentration (g/L) will be compared between groups.
Blood Flow Velocity of the Portal Vein at 6 Months Postoperation
Time frame: 6 months postoperation
Blood flow velocity (cm/s) in the portal vein, measured by Doppler ultrasound, will be compared between groups.
Vascular Diameter of the Portal Vein at 6 Months Postoperation
Time frame: 6 months postoperation
Vascular diameter (mm) of the portal vein, measured by Doppler ultrasound, will be compared between groups.
Blood Flow Velocity of the Splenic Vein at 6 Months Postoperation
Time frame: 6 months postoperation
Blood flow velocity (cm/s) in the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Vascular Diameter of the Splenic Vein at 6 Months Postoperation
Time frame: 6 months postoperation
Vascular diameter (mm) of the splenic vein, measured by Doppler ultrasound, will be compared between groups.
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 6 Months Postoperation
Time frame: 6 months postoperation
Indocyanine green retention rate at 15 minutes (%), a measure of liver function, will be compared between groups.
Incidence of Portal Venous System Thrombosis within 6 Months Postoperation
Time frame: 6 months postoperation
The number of participants with newly developed thrombosis in the portal venous system, confirmed by imaging, will be recorded and compared.
26 secondary outcomes
Comparison of Humoral Immune Marker Levels at 7 Days Postoperation
Time frame: 7 days postoperation
Comparison of Humoral Immune Marker Levels at 3 months Postoperation
Time frame: 3 months postoperation
Platelet Count at 3 Months Postoperation
Time frame: 3 months postoperation
Platelet Count at 12 Months Postoperation
Time frame: 12 months postoperation
Platelet Count at 1 Month Postoperation
Time frame: 1 month postoperation
Comparison of Humoral Immune Marker Levels at 1 Month Postoperation
Time frame: 1 month postoperation
Comparison of Humoral Immune Marker Levels at 12 Months Postoperation
Time frame: 12 Months postoperation
White Blood Cell Count at 1 Month Postoperation
Time frame: 1 month postoperation
White Blood Cell Count at 3 Months Postoperation
Time frame: 3 months postoperation
White Blood Cell Count at 12 Months Postoperation
Time frame: 12 months postoperation
Hemoglobin Level at 1 Month Postoperation
Time frame: 1 month postoperation
Hemoglobin Level at 3 Months Postoperation
Time frame: 3 months postoperation
Hemoglobin Level at 12 Months Postoperation
Time frame: 12 months postoperation
Blood Flow Velocity of the Portal Vein at 3 Months Postoperation
Time frame: 3 months postoperation
Blood Flow Velocity of the Portal Vein at 12 Months Postoperation
Time frame: 12 months postoperation
Vascular Diameter of the Portal Vein at 3 Months Postoperation
Time frame: 3 months postoperation
Vascular Diameter of the Portal Vein at 12 Months Postoperation
Time frame: 12 months postoperation
Blood Flow Velocity of the Splenic Vein at 3 Months Postoperation
Time frame: 3 months postoperation
Blood Flow Velocity of the Splenic Vein at 12 Months Postoperation
Time frame: 12 months postoperation
Vascular Diameter of the Splenic Vein at 3 Months Postoperation
Time frame: 3 months postoperation
Vascular Diameter of the Splenic Vein at 12 Months Postoperation
Time frame: 12 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 3 Months Postoperation
Time frame: 3 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 9 Months Postoperation
Time frame: 9 months postoperation
Indocyanine Green Retention Rate at 15 Minutes (ICG R15) at 12 Months Postoperation
Time frame: 12 months postoperation
Incidence of Portal Venous System Thrombosis within 12 Months Postoperation
Time frame: 12 months postoperation
Incidence of Postoperative Complications within 30 Days
Time frame: 30 days postoperation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Guo-Qing Jiang study chair
Clinical Medical College, 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 Partial Splenectomy in people with Cirrhoses, 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo-Qing Jiang (+8651487373382, jgqing2003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Humoral Immune Markers from Baseline to 6 Months Postoperation (time frame: Baseline (preoperative) and 6 months postoperation). The study lists 10 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 3 Oct 2025.