Splenic Artery AneurysmNCT07053605
Clinical Study on Laparoscopic Resection of Splenic Artery Aneurysm With Preservation of Spleen
A study testing laparoscopic resection of splenic artery aneurysm with preservation of spleen in people with Splenic Artery Aneurysm and Immune Function, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
In this study, researchers examined the changes in related indicators such as immune function, splenic vein,proper hepatic artery, and portal venous hemodynamics following laparoscopic resection of a splenic artery aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Splenic Artery Aneurysm, Immune Function, Hemodynamics
- What is being tested?
- laparoscopic resection of splenic artery aneurysm with preservation of spleen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to 30 Jun 2027
- 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
- Asymptomatic splenic artery aneurysms with a diameter>2 cm,ruptured splenic artery aneurysms,and splenic artery aneurysms with a diameter increase>0.5 cm/year.
- Aneurysm located in the main trunk of the splenic artery. Informed consent to participate in the study.
Who cannot join
- Patients with malignancies Hepatic cirrhosis with portal hypertension peptic ulcer disease Recent peptic ulcer disease History of Hemorrhagic stroke Pregnancy hematological diseases 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, Yangzhou University
Yangzhou, Jiangsu, China
Guo-Qing Jiang, +8651487373382, jgqing2003@hotmail.com
Guo-Qing Jiang
About this study
In this study, researchers examined the changes in related indicators such as immune function, splenic vein,proper hepatic artery, and portal venous hemodynamics following laparoscopic resection of a splenic artery aneurysm. We determined the changes in these patient-related indicators after surgical treatment and whether these changes could improve patient outcomes.
Read the detailed description
Patients with Splenic Artery Aneurysm were recruited in accordance with the research inclusion criteria, and their general demographic information was collected. After thorough preoperative preparation, the same surgical team performed laparoscopic resection of the splenic artery aneurysm. Postoperatively,the same nursing team provided standardized care. Subsequently, patients received a standardized postoperative treatment protocol, which included pharmacotherapy, additional therapeutic interventions, and follow-up visits. During the treatment period, routine blood tests,liver function tests, coagulation function,immune function, as well as the hemodynamics of the portal vein, proper hepatic artery, and splenic vein were monitored preoperatively and at 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively.
- Conditions
- Splenic Artery Aneurysm, Immune Function, Hemodynamics
- Being tested
- laparoscopic resection of splenic artery aneurysm with preservation of spleen
- Keywords
- Laparoscopy, resection of splenic artery aneurysm, Immune function, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic resection of splenic artery aneurysm with preservation of spleenProcedure or surgery
The laparoscopic resection of splenic artery aneurysm with preservation of spleen is performed by the same surgical team.
| Study group | Role | What they receive |
|---|---|---|
| The laparoscopic resection of splenic artery aneurysm is performed by the same surgical team. | Experimental | The laparoscopic resection of splenic artery aneurysm with preservation of spleen is performed by the same surgical team. Receives: Procedure: laparoscopic resection of splenic artery aneurysm with preservation of spleen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The immune function at 7 days after surgery
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 7 days after surgery.
Measured: 7 days
The immune function at 1 month after surgery
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 1 month after surgery.
Measured: 1 month
The immune function at 3 months after surgery
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 3 months after surgery.
Measured: 3 months
The immune function at 6 months after surgery
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 6 months after surgery.
Measured: 6 months
The immune function at 12months after surgery
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 12months after surgery.
Measured: 12months
Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 1 month postoperatively.
1 month
Measured: 1 month
Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 3 months postoperatively.
3 months
Measured: 3 months
Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 6 months postoperatively.
6 months
Measured: 6 months
Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 12 months postoperatively.
12 months
Measured: 12 months
Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 1 month postoperatively.
1 month
Measured: 1 month
Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 3 months postoperatively.
3 months
Measured: 3 months
Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 6 months postoperatively.
6 months
Measured: 6 months
Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 12 months postoperatively.
12 months
Measured: 12 months
Thrombosis in the Portal Venous System.
1 month
Measured: 1 month
Thrombosis in the Portal Venous System.
3 months
Measured: 3 months
Thrombosis in the Portal Venous System.
6 months
Measured: 6 months
Thrombosis in the Portal Venous System.
12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start23 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenic Artery AneurysmStudies 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
- 10 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
- NCT07053605
- Sponsor's protocol ID
- YZUC-013
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 8 Jul 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Laparoscopic Resection of Splenic Artery Aneurysm With Preservation of Spleen
- ClinicalTrials.gov ID
- NCT07053605
- Acronym / sponsor ID
- YZUC-013
- Conditions
- Splenic Artery Aneurysm, Immune Function, Hemodynamics
- Keywords
- Laparoscopy, resection of splenic artery aneurysm, Immune function, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Jul 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, researchers examined the changes in related indicators such as immune function, splenic vein,proper hepatic artery, and portal venous hemodynamics following laparoscopic resection of a splenic artery aneurysm. We determined the changes in these patient-related indicators after surgical treatment and whether these changes could improve patient outcomes.
Detailed description
Patients with Splenic Artery Aneurysm were recruited in accordance with the research inclusion criteria, and their general demographic information was collected. After thorough preoperative preparation, the same surgical team performed laparoscopic resection of the splenic artery aneurysm. Postoperatively,the same nursing team provided standardized care. Subsequently, patients received a standardized postoperative treatment protocol, which included pharmacotherapy, additional therapeutic interventions, and follow-up visits. During the treatment period, routine blood tests,liver function tests, coagulation function,immune function, as well as the hemodynamics of the portal vein, proper hepatic artery, and splenic vein were monitored preoperatively and at 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The laparoscopic resection of splenic artery aneurysm is performed by the same surgical team. | Experimental | Procedure: laparoscopic resection of splenic artery aneurysm with preservation of spleenThe laparoscopic resection of splenic artery aneurysm with preservation of spleen 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 (2 listed)
- Asymptomatic splenic artery aneurysms with a diameter>2 cm,ruptured splenic artery aneurysms,and splenic artery aneurysms with a diameter increase>0.5 cm/year.
- Aneurysm located in the main trunk of the splenic artery. Informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients with malignancies Hepatic cirrhosis with portal hypertension peptic ulcer disease Recent peptic ulcer disease History of Hemorrhagic stroke Pregnancy hematological diseases Uncontrolled Hypertension Human immunodeficiency virus (HIV) infection
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 resection of splenic artery aneurysm with preservation of spleenThe laparoscopic resection of splenic artery aneurysm with preservation of spleen is performed by the same surgical team. | Procedure or surgery | The laparoscopic resection of splenic artery aneurysm is performed by the same surgical team. |
Primary outcome
The immune function at 7 days after surgery
Time frame: 7 days
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 7 days after surgery.
The immune function at 1 month after surgery
Time frame: 1 month
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 1 month after surgery.
The immune function at 3 months after surgery
Time frame: 3 months
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 3 months after surgery.
The immune function at 6 months after surgery
Time frame: 6 months
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 6 months after surgery.
The immune function at 12months after surgery
Time frame: 12months
The level of the immune function(Complement C3; Complement C4; IgG; IgA; IgM;CD19;CD20;CD16;CD56;CD3;CD4) at 12months after surgery.
Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 1 month postoperatively.
Time frame: 1 month
1 month
Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 3 months postoperatively.
Time frame: 3 months
3 months
Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 6 months postoperatively.
Time frame: 6 months
6 months
Routine blood tests (Erythrocyte Count; Hemoglobins; Red Cell Distribution Width; White Blood Cell Count; Neutrophils; Lymphocytes; Monocytes; Eosinophils; Basophils; Platelet Count; Mean Platelet Volume; Blood Platelet) at 12 months postoperatively.
Time frame: 12 months
12 months
Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 1 month postoperatively.
Time frame: 1 month
1 month
Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 3 months postoperatively.
Time frame: 3 months
3 months
Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 6 months postoperatively.
Time frame: 6 months
6 months
Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 12 months postoperatively.
Time frame: 12 months
12 months
Thrombosis in the Portal Venous System.
Time frame: 1 month
1 month
Thrombosis in the Portal Venous System.
Time frame: 3 months
3 months
Thrombosis in the Portal Venous System.
Time frame: 6 months
6 months
Thrombosis in the Portal Venous System.
Time frame: 12 months
12 months
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 8 Jul 2025.
- Individual participant dataSharing planned: No
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 resection of splenic artery aneurysm with preservation of spleen in people with Splenic Artery Aneurysm and Immune Function, 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 2 inclusion and 1 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 8 Jul 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?
The immune function at 7 days after surgery (time frame: 7 days). The study lists 17 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 8 Jul 2025.