Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Technical success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Group T
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.
Intervention: Trocar percutaneous cholecystostomy (Procedure)
Group S
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.
Intervention: Seldinger percutaneous cholecystostomy (Procedure)
Outcomes
Primary Outcomes
Technical success
Time Frame: At the end of the procedure
Image verified catheter placement within the gallbladder and subsequent bile aspiration
Procedure-related complications
Time Frame: 3 months
Minor or major complications attributed to the procedure
Secondary Outcomes
- Clinical success(72 hours)
- Duration of the procedure(Intraprocedural)
- Intraprocedural pain(End of the procedure)
- Post-procedural pain(12 hours)
Investigators
Stavros Spiliopoulos
Assistant Professor in Interventional Radiology
Attikon Hospital