Evaluating ultrasound-guided cholecystostomy using the trocar technique
Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
This study is testing a new way to place a drainage tube in the gallbladder using ultrasound to see if it's safe and effective for patients who need it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 1 site (Chaïdári, Athens) |
| Trial ID | NCT06330688 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of ultrasound-guided percutaneous cholecystostomy (PC) using the trocar technique at the patient's bedside. It will include patients requiring PC for various underlying causes, while excluding those needing CT guidance or with uncontrolled coagulation disorders. Data collected will encompass patient demographics, technical details of the procedure, and outcomes during hospitalization and a 3-month follow-up. The study will monitor complications, pain levels, and clinical success rates associated with the procedure.
Who should consider this trial
Good fit: Ideal candidates include adults requiring percutaneous cholecystostomy for acute cholecystitis.
Not a fit: Patients under 18 years old or those needing CT-guided catheter placement will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective method for managing acute cholecystitis.
How similar studies have performed: Previous studies have shown promising results with ultrasound-guided techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients requiring PC, irrespective of the underlying cause and indication, are suitable for inclusion in the study. Exclusion Criteria: * Patients are going to be excluded from the study if they are younger than 18 years, if they require PC catheter placement under CT guidance (according to the operator's judgement), or if they suffer from severe uncontrollable coagulopathy.
Where this trial is running
Chaïdári, Athens
- Attikon University Hospital — Chaïdári, Athens, Greece (Recruiting)
Study contacts
- Study coordinator: Stavros Spiliopoulos, MD, PhD, Associate Professor
- Email: stavspiliop@gmail.com
- Phone: +302105831812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.