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临床试验/NCT07053605
NCT07053605招募中不适用

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

Northern Jiangsu People's Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
The immune function at 7 days after surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

The immune function at 7 days after surgery

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 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.

时间窗: 12 months

12 months

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

时间窗: 1 month

1 month

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

时间窗: 3 months

3 months

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

时间窗: 6 months

6 months

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

时间窗: 12 months

12 months

Thrombosis in the Portal Venous System.

时间窗: 12 months

12 months

The immune function at 1 month after surgery

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

时间窗: 1 month

1 month

The immune function at 7 days after surgery

时间窗: 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.

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.

时间窗: 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 12 months postoperatively.

时间窗: 12 months

12 months

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

时间窗: 1 month

1 month

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

时间窗: 3 months

3 months

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

时间窗: 6 months

6 months

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

时间窗: 12 months

12 months

Thrombosis in the Portal Venous System.

时间窗: 12 months

12 months

次要结局

未报告次要终点

研究者

发起方
Northern Jiangsu People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guo-Qing Jiang

Clinical Professor

Northern Jiangsu People's Hospital

研究点 (1)

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