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NCT Number: NCT07053605

Clinical Study on Laparoscopic Resection of Splenic Artery Aneurysm With Preservation of Spleen

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.

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Key information

Conditions

Splenic Artery Aneurysm Hemodynamics Immune Function

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, China

Location status: Recruiting

Location contact

Guo-Qing Jiang

CONTACT

[email protected]

+8651487373382

Guo-Qing Jiang

PRINCIPAL_INVESTIGATOR

Hao Dong

PRINCIPAL_INVESTIGATOR

Tian-Ming Gao

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

laparoscopic resection of splenic artery aneurysm with preservation of spleen

Procedure

The laparoscopic resection of splenic artery aneurysm with preservation of spleen is performed by the same surgical team.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Thrombosis in the Portal Venous System.

    Time frame: 1 month

    1 month

  15. Thrombosis in the Portal Venous System.

    Time frame: 3 months

    3 months

  16. Thrombosis in the Portal Venous System.

    Time frame: 6 months

    6 months

  17. Thrombosis in the Portal Venous System.

    Time frame: 12 months

    12 months

Study contacts

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

Dou-Sheng Bai

CONTACT

[email protected]

+8651487373382

Guo-Qing Jiang

CONTACT

[email protected]

+8651487373382

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2025
Registry last updated
Jul 8, 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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