Trials / Completed
CompletedNCT04602156
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Attikon Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2020-09-16
- Primary completion
- 2022-11-22
- Completion
- 2022-11-22
- First posted
- 2020-10-26
- Last updated
- 2022-11-23
Locations
1 site across 1 country: Greece
Source: ClinicalTrials.gov record NCT04602156. Inclusion in this directory is not an endorsement.