US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.

Conditions
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Cholecystitis

Intervention / Treatment
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* Procedure: Trocar percutaneous cholecystostomy
* Procedure: Seldinger percutaneous cholecystostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group T<br>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. | Procedure: Trocar percutaneous cholecystostomy<br>* 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.<br>|
| Active Comparator: Group S<br>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. | Procedure: Seldinger percutaneous cholecystostomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous cholecystostomy, ultrasound-guided, interventional radiology, Trocar, Seldinger