Percutaneous cholecystostomy: techniques and applications.
Nikolaos-Achilleas Arkoudis, Ornella Moschovaki-Zeiger, Lazaros Reppas...
https://pubmed.ncbi.nlm.nih.gov/37338588Actively Recruiting
Age: 18Years +
All Genders
ID06330688
Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Led by Attikon Hospital · Updated on 2024-03-26
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ultrasound-guided percutaneous cholecystostomy (PC) using the trocar technique. This procedure is studied in patients needing PC for any reason, excluding those who need CT guidance or have uncontrolled bleeding disorders. The study aims to understand technical success and potential complications over a three-month follow-up period. The study involves patients undergoing PC, a minimally invasive procedure that places a catheter into the gallbladder to drain and relieve pressure. The procedure is done at the patient's bedside using ultrasound guidance. Researchers will record detailed patient information including demographics, health status, and procedure details. Imaging tests like ultrasound or CT may be used before diagnosis and after the procedure if needed. Monitoring will include clinical exams and lab tests. Participants will be closely observed during hospitalization and for three months afterward to track complications and pain levels. The duration of the procedure and clinical success within 72 hours will also be measured. Patients will receive instructions for catheter care before discharge. All clinical and diagnostic tests are part of standard hospital care, so the study does not add financial burden to the hospital. The total follow-up includes monitoring for up to three months after the procedure.
CONDITIONS
Brief Title
Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients requiring percutaneous cholecystostomy (PC) regardless of underlying cause or indication
- Age 18 years or older
You will not qualify if you...
- Younger than 18 years
- Require PC catheter placement under CT guidance
- Have severe uncontrollable coagulopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 1 hour
Participants undergo ultrasound-guided percutaneous cholecystostomy using the trocar technique to drain and decompress the gallbladder.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 3 months
Participants are monitored clinically and with laboratory tests. Imaging such as ultrasound or CT may be performed if necessary. Written instructions are provided before discharge regarding catheter management and care.
Approximately 3 months of clinical and laboratory monitoring with visits as needed
Trial Site Locations
Total: 1 location
1
Attikon University Hospital
Chaïdári, Athens, Greece, 12461
Actively Recruiting
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Research Team
S
Stavros Spiliopoulos, MD, PhD, Associate Professor
N
Nikolaos Achilleas Arkoudis, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Image-guided percutaneous cholecystostomy: challenging the norms.
Nikolaos-Achilleas Arkoudis, Lazaros Reppas, Stavros Spiliopoulos
https://pubmed.ncbi.nlm.nih.gov/38294540US-guided trocar versus Seldinger technique for percutaneous cholecystostomy (TROSELC II trial).
Nikolaos-Achilleas Arkoudis, Ornella Moschovaki-Zeiger, Stavros Grigoriadis...
https://pubmed.ncbi.nlm.nih.gov/37081229Two-Center Prospective Comparison of the Trocar and Seldinger Techniques for Percutaneous Cholecystostomy.
Lazaros Reppas, Nikolaos-Achilleas Arkoudis, Stavros Spiliopoulos...
https://pubmed.ncbi.nlm.nih.gov/31573856