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A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T | Experimental | Patients will be randomized to undergo PC catheter placement (8-French) using the trocar method under US guidance while receiving local anesthesia and opioid analgesic, in a bedside setting, either in the US room or in the ICU. |
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| Group S | Active Comparator | Patients will be randomized to undergo PC catheter placement (8-French) using the Sellinger method under US guidance while receiving local anesthesia and opioid analgesic, in a bedside setting, either in the US room or in the ICU. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trocar percutaneous cholecystostomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Image verified catheter placement within the gallbladder and subsequent bile aspiration | At the end of the procedure |
| Procedure-related complications | Minor or major complications attributed to the procedure | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the procedure | The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder | Intraprocedural |
| Intraprocedural pain | pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Spiliopoulos, MD, PhD | ATTIKO University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Attikon" University General Hospital | Athens | Attica | 12461 | Greece |
IPD could be available upon reasonable request
IPD could be available after the completion of the study upon reasonable request
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| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Seldinger percutaneous cholecystostomy | Procedure | 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. |
|
| End of the procedure |
| Post-procedural pain | 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) | 12 hours |
| Clinical success | Gradual subsidence of signs, symptoms, and elevated inflammatory markers | 72 hours |