CClinicalTrials.gg
CompletedNCT06960486Updated May 7, 2025

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

An interventional study of Bedside ultrasound-guided real-time biliary drainage and traditional appointment ultrasound in Biliary Tract Infection, sponsored by Hebei Medical University. Completed at 1 site in China. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Hebei Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
Up to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Biliary Tract Infection

Keywords

  • infection of biliary tract
  • emergency bedside ultrasound
  • ultrasound-guided biliary drainage
03

Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    emergency bedside ultrasound group

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

    Procedure: Bedside ultrasound-guided real-time biliary drainage

  • Other
    traditional ultrasound group

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

    Procedure: traditional appointment ultrasound

Interventions

  • ProcedureBedside ultrasound-guided real-time biliary drainage

    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

  • Proceduretraditional appointment ultrasound

    Traditional appointment ultrasound

05

What researchers measure

Primary outcomes

  1. Puncture time

    Total time between admission and completion of ultrasound puncture

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

  2. Hospitalization time

    hospitalization time

    Time frame: From hospitalization to discharge, about 30days

  3. Hospitalization cost

    Hospitalization expenses

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

06

Study locations

1 site
  • The Second Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050000, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06960486
Lead sponsor
Hebei Medical University
Responsible party
Chunjie Liu (professor, Hebei Medical University) — Principal investigator
First posted
May 7, 2025
Start date
Dec 1, 2018
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
May 7, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion