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

NCT06960486 | Completed

• 1 other identifier: 20180063
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Tract Infection

Keywords

infection of biliary tract; emergency bedside ultrasound; ultrasound-guided biliary drainage

Outcome Measures

Primary Outcomes (3)

• Puncture time

  Total time between admission and completion of ultrasound puncture

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

• Hospitalization time

  hospitalization time

  From hospitalization to discharge, about 30days

• Hospitalization cost

  Hospitalization expenses

  From admission to the end of treatment, about 30 days

Study Arms (2)

emergency bedside ultrasound group

EXPERIMENTAL

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

traditional ultrasound group

OTHER

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

Procedure: traditional appointment ultrasound

Interventions

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

emergency bedside ultrasound group

traditional appointment ultrasound PROCEDURE

Traditional appointment ultrasound

traditional ultrasound group

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 7, 2025
• Study Start: December 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)