Cholecystitis
Conditions
Keywords
Percutaneous cholecystostomy, ultrasound-guided, interventional radiology, Trocar, Seldinger
Brief summary
A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy
Detailed description
This is a single-center, randomized, controlled trial (RCT), comparing bedside US-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy (PC). The study will randomize a total of 100 consecutive patients (50 in each group) undergoing PC at one large tertiary university hospital. The primary endpoints will be technical success and procedure-related complication rates. Secondary endpoints will be procedural duration, pain assessment, and clinical success after up to 3 months of follow-up.
Interventions
PROCEDURETrocar percutaneous cholecystostomy
Percutaneous cholecystostomy using the one-step Trocar technique under US guidance. An 8Fr Trocar catheter will be inserted percutaneously within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.
PROCEDURESeldinger percutaneous cholecystostomy
Percutaneous cholecystostomy using the Seldinger technique under US guidance. Following percutaneous puncture of the gallbladder with an 18G needle under real-time US guidance, an 8Fr catheter will be inserted percutaneously over the wire within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.
Sponsors
Attikon Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients requiring PC, regardless of the underlying cause. * Signed informed consent form
Exclusion criteria
* Age \<18 years or \>100 years * The necessity for CT-guided PC catheter placement, according to the judgment of the performing physician * Severe uncontrollable coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | At the end of the procedure | Image verified catheter placement within the gallbladder and subsequent bile aspiration |
| Procedure-related complications | 3 months | Minor or major complications attributed to the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the procedure | Intraprocedural | The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder |
| Intraprocedural pain | End of the procedure | pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score |
| Post-procedural pain | 12 hours | Pain experienced up to12 hours after procedure assessed using a standard visual analogue score (VAS - Visual Analog Scale 0-10, 0 representing no pain & 10 representing worst pain experienced) |
| Clinical success | 72 hours | Gradual subsidence of signs, symptoms, and elevated inflammatory markers |
Countries
Greece
Outcome results
None listed