Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAttikon Hospital
About this trial
The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients requiring PC, irrespective of the underlying cause and indication, are suitable for inclusion in the study.
Disqualifiers
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.
Trial population
All patients requiring PC, irrespective of the underlying cause, comorbidities and indication, and irrespective of patient demographics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
percutaneous cholecystostomy
Procedure/SurgeryPC is a minimally invasive, nonsurgical, image-guided intervention that aims to drain and decompress the gallbladder by placing a pigtail catheter through the abdominal wall into the gallbladder lumen.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Technical success
Image verification of correct PC catheter placement within the gallbladder lumen with subsequent bile aspiration at the time of initial catheter placement
Time frame
Up to 1 hour2
Procedure-related complications
Complications attributed to the procedure
Time frame
Up to 3 monthsSecondary outcomes
1
duration of the procedure
The time passed from local anesthesia administration until final pigtail catheter positioning within the gallbladder lumen
Time frame
Up to 1 hour2
intraprocedural and post-procedural pain
pain experienced during and up to 12 h after the procedure according to the VAS (Visual Analog Scale). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Time frame
Up to 12 hours3
clinical success
The subsidence of signs, symptoms and elevated inflammatory markers up to 72 h after PC (Subsidence of Murphy's sign, pain or tenderness in the right upper quadrant, fever, leukocytosis, elevated C-reactive protein)
Time frame
Up to 72 hoursSponsors and contacts
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Source ClinicalTrials.gov