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临床试验/NCT06960486
NCT06960486已完成不适用

Bedside Ultrasound-guided Real-time Biliary Drainage by Emergency Surgeon Improving Prognosis in the Frail and High Risk Elderly Patients With Severe Acute Suppurative Infection of Biliary Tract: A Randomised Controlled Trial

Hebei Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Puncture time

研究概览

简要总结

Acute biliary tract infection is a kind of disease caused by bacteria of biliary tract infection, mainly including acute cholecystitis and acute cholangitis, especially acute obstructive suppurative cholangitis (AOSC),which can lead to septic shock and multiple organ failure,and the mortality rate is high in the frail and high risk elderly patients. Our study involved bedside ultrasoundguided real-time biliary drainage by emergency surgeon in the frail and high risk elderly patients with severe acute suppurative infection of biliary tract,the goal of this clinical trial is to learn if it can improve patient prognosis and reduce mortality.

Participants will be divided into experimental group (emergency bedside ultrasound group) and controlgroup (traditional ultrasound group). The experimental group will be performed gallbladder or bile duct puncture under the guidance of emergency bedside ultrasound, while the control group will be performed puncture by traditional appointment ultrasound, The accuracy of ultrasound diagnosis, the total time of examination and puncture treatment,complications, hospitalization time and expenses will be compared between the two groups.

详细描述

After admission, vital signs will be collected by nurses and scored according to the Canadian health and aging clinical frailty scale 3 . Emergency surgeons will evaluate patients' airway, respiratory and circulatory status and intervene according to their condition. For patients with stable vital signs, CT will be performed first. Patients with untable vital signs and hemodynamics, bedside ultrasound will be performed by an emergency surgeon while aggressive rescue measures and further CT scans will be performed if the patient's condition permitted.The patients in the experimental group will be diagnosed by emergency surgeon using Philips CX50 portable ultrasound and treated by ultrasound-guided puncture and drainage at the first time, these included ultrasound-guided percutaneous transhepatic gallbladder drainage (PTGD) and percutaneous transhepatic choledochal drainage (PTCD) .In the control group, the patients will be scheduled for puncture and drainage treatment in the traditional ultrasound department at the same time of stabilizing vital signs.Then the two groups of patients will be followed up, through CT results to understand the accuracy of emergency bedside ultrasound.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 75 years.
  • •Patients with severe acute cholecystitis, and/or acute obstructive suppurative cholangitis who need emergency bedside ultrasound-guided biliary tract puncture.
  • •All patients were informed and volunteered to participate in the study.

排除标准

  • •Age < 75 years old.
  • •Patients who died before being admitted to the hospital for puncture treatment.
  • •Patients with severe bleeding tendency and coagulopathy.
  • •Patients who could not cooperate with the examination for any reason.
  • •Patients with a history of mental illness.

研究组 & 干预措施

emergency bedside ultrasound group

Experimental

The experimental group will be performed gallbladder or bile duct puncture under the guidance of emergency bedside ultrasound.

干预措施: Bedside ultrasound-guided real-time biliary drainage (Procedure)

traditional ultrasound group

Other

The control group will be performed puncture by traditional appointment ultrasound.

干预措施: traditional appointment ultrasound (Procedure)

结局指标

主要结局

Puncture time

时间窗: From admission time to completion of puncture time, assessed up to 3 hours

Total time between admission and completion of ultrasound puncture

Hospitalization time

时间窗: From hospitalization to discharge, about 30days

hospitalization time

Hospitalization cost

时间窗: From admission to the end of treatment, about 30 days

Hospitalization expenses

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunjie Liu

professor

Hebei Medical University

研究点 (1)

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