NCT07053605

Brief 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. We determined the changes in these patient-related indicators after surgical treatment and whether these changes could improve patient outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

June 23, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

June 23, 2025

Last Update Submit

July 1, 2025

Conditions

Splenic Artery AneurysmImmune FunctionHemodynamics

Keywords

Laparoscopyresection of splenic artery aneurysmImmune functionHemodynamics

Outcome Measures

Primary Outcomes (17)

  • 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.

    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.

    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.

    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.

    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.

    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

    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

    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

    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

    12 months

  • Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 1 month postoperatively.

    1 month

    1 month

  • Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 3 months postoperatively.

    3 months

    3 months

  • Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 6 months postoperatively.

    6 months

    6 months

  • Hemodynamics (Vascular Diameter; Blood Flow Velocity) of the splenic vein,proper hepatic artery,and portal vein at 12 months postoperatively.

    12 months

    12 months

  • Thrombosis in the Portal Venous System.

    1 month

    1 month

  • Thrombosis in the Portal Venous System.

    3 months

    3 months

  • Thrombosis in the Portal Venous System.

    6 months

    6 months

  • Thrombosis in the Portal Venous System.

    12 months

    12 months

Study Arms (1)

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.

Procedure: laparoscopic resection of splenic artery aneurysm with preservation of spleen

Interventions

laparoscopic resection of splenic artery aneurysm with preservation of spleenPROCEDURE

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Medical College, Yangzhou University

Yangzhou, Jiangsu, China, China

RECRUITING

Study Officials

  • Guo-Qing Jiang

    Clinical Medical College, Yangzhou University

    STUDY CHAIR

Central Study Contacts

Guo-Qing Jiang

CONTACT

+8651487373382jgqing2003@hotmail.com

Dou-Sheng Bai

CONTACT

+8651487373382jgqing2003@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 8, 2025

Study Start

June 23, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)