US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy (TROSELCII)
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|ClinicalTrials.gov Identifier: NCT04602156|
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : February 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Cholecystitis||Procedure: Trocar percutaneous cholecystostomy Procedure: Seldinger percutaneous cholecystostomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.|
|Actual Study Start Date :||September 16, 2020|
|Estimated Primary Completion Date :||September 16, 2022|
|Estimated Study Completion Date :||December 16, 2022|
Experimental: 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.
Procedure: Trocar 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.
Active Comparator: 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.
Procedure: Seldinger 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.
- 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
- Duration of the procedure [ Time Frame: Intraprocedural ]The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder
- Intraprocedural pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 72 hours ]Gradual subsidence of signs, symptoms, and elevated inflammatory markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602156
|Contact: Stavros Spiliopoulosemail@example.com|
|Contact: Nikolaos Arkoudisfirstname.lastname@example.org|
|Principal Investigator:||Stavros Spiliopoulos, MD, PhD||ATTIKO University Hospital|