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Completed

NCT Number: NCT06960486

Ultrasound-guided Biliary Drainage Improving Prognosis in the Frail and High Risk Elderly Patients

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.

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Key information

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Bedside ultrasound-guided real-time biliary drainage

Procedure

Bedside ultrasound-guided real-time biliary drainage by emergency surgeon in the frail and high risk elderly patients with severe acute suppurative infection of biliary tract

traditional appointment ultrasound

Procedure

Traditional appointment ultrasound

Primary outcomes

  1. Puncture time

    Time frame: From admission time to completion of puncture time, assessed up to 3 hours

    Total time between admission and completion of ultrasound puncture

  2. Hospitalization time

    Time frame: From hospitalization to discharge, about 30days

    hospitalization time

  3. Hospitalization cost

    Time frame: From admission to the end of treatment, about 30 days

    Hospitalization expenses

Sponsors and collaborators

Lead sponsor

Hebei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 7, 2025
Registry last updated
May 7, 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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