Biliary Tract InfectionNCT06960486
Ultrasound-guided Biliary Drainage Improving Prognosis in the Frail and High Risk Elderly Patients
A study testing Bedside ultrasound-guided real-time biliary drainage and traditional appointment ultrasound in people with Biliary Tract Infection, run by Hebei Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Biliary Tract Infection
- What is being tested?
- Bedside ultrasound-guided real-time biliary drainage and traditional appointment ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official 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
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.
- Conditions
- Biliary Tract Infection
- Being tested
- Bedside ultrasound-guided real-time biliary drainage, traditional appointment ultrasound
- Keywords
- infection of biliary tract, emergency bedside ultrasound, ultrasound-guided biliary drainage
- Medical subject headings
- Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside ultrasound-guided real-time biliary drainageProcedure or surgery
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 ultrasoundProcedure or surgery
Traditional appointment ultrasound
| Study group | Role | What they receive |
|---|---|---|
| emergency bedside ultrasound group | Experimental | The experimental group will be performed gallbladder or bile duct puncture under the guidance of emergency bedside ultrasound. Receives: Procedure: Bedside ultrasound-guided real-time biliary drainage |
| traditional ultrasound group | Other | The control group will be performed puncture by traditional appointment ultrasound. Receives: Procedure: traditional appointment ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture time
Total time between admission and completion of ultrasound puncture
Measured: From admission time to completion of puncture time, assessed up to 3 hours
Hospitalization time
hospitalization time
Measured: From hospitalization to discharge, about 30days
Hospitalization cost
Hospitalization expenses
Measured: From admission to the end of treatment, about 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Dec 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjie Liu, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960486
- Sponsor's protocol ID
- 20180063
- Status last verified
- May 2025
- First submitted
- 9 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06960486
- Acronym / sponsor ID
- 20180063
- Conditions
- Biliary Tract Infection
- Keywords
- infection of biliary tract, emergency bedside ultrasound, ultrasound-guided biliary drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| emergency bedside ultrasound group | Experimental | Procedure: Bedside ultrasound-guided real-time biliary drainageThe experimental group will be performed gallbladder or bile duct puncture under the guidance of emergency bedside ultrasound. |
| traditional ultrasound group | Other | Procedure: traditional appointment ultrasoundThe control group will be performed puncture by traditional appointment ultrasound. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside ultrasound-guided real-time biliary drainageBedside 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 | Procedure or surgery | emergency bedside ultrasound group |
| traditional appointment ultrasoundTraditional appointment ultrasound | Procedure or surgery | traditional ultrasound group |
Primary outcome
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
Hospitalization time
Time frame: From hospitalization to discharge, about 30days
hospitalization time
Hospitalization cost
Time frame: From admission to the end of treatment, about 30 days
Hospitalization expenses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedside ultrasound-guided real-time biliary drainage and traditional appointment ultrasound in people with Biliary Tract Infection, run by Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puncture time (time frame: From admission time to completion of puncture time, assessed up to 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.