CholecystitisTROSELCIINCT04602156
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
A study testing Trocar percutaneous cholecystostomy and Seldinger percutaneous cholecystostomy in people with Cholecystitis, run by Attikon Hospital at 1 site in Greece.
Trial summary
A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- Trocar percutaneous cholecystostomy and Seldinger percutaneous cholecystostomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 16 Sep 2020to 22 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients requiring PC, regardless of the underlying cause.
- Signed informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy
Read the 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
- Cholecystitis
- Being tested
- Trocar percutaneous cholecystostomy, Seldinger percutaneous cholecystostomy
- Keywords
- Percutaneous cholecystostomy, ultrasound-guided, interventional radiology, Trocar, Seldinger
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trocar percutaneous cholecystostomyProcedure or surgery
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.
Seldinger percutaneous cholecystostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Trocar percutaneous cholecystostomy |
| 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. Receives: Procedure: Seldinger percutaneous cholecystostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Image verified catheter placement within the gallbladder and subsequent bile aspiration
Measured: At the end of the procedure
Procedure-related complications
Minor or major complications attributed to the procedure
Measured: 3 months
Secondary outcomes (4)
Duration of the procedure
The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder
Measured: 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
Measured: 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)
Measured: 12 hours
Clinical success
Gradual subsidence of signs, symptoms, and elevated inflammatory markers
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start16 Sep 2020
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Spiliopoulos, Attikon Hospital
- Investigators
- Stavros Spiliopoulos, MD, PhD, Principal investigator, ATTIKO University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602156
- Sponsor's protocol ID
- EBD 515/16-9-2020
- Acronym
- TROSELCII
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2020
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD could be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
- ClinicalTrials.gov ID
- NCT04602156
- Acronym / sponsor ID
- TROSELCII / EBD 515/16-9-2020
- Conditions
- Cholecystitis
- Keywords
- Percutaneous cholecystostomy, ultrasound-guided, interventional radiology, Trocar, Seldinger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T | Experimental | Procedure: Trocar percutaneous cholecystostomyPatients 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. |
| Group S | Active comparator | Procedure: Seldinger percutaneous cholecystostomyPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients requiring PC, regardless of the underlying cause.
- Signed informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trocar percutaneous cholecystostomyPercutaneous 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 or surgery | Group T |
| Seldinger percutaneous cholecystostomyPercutaneous 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. | Procedure or surgery | Group S |
Primary outcome
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
4 secondary outcomes
Duration of the procedure
Time frame: Intraprocedural
Intraprocedural pain
Time frame: End of the procedure
Post-procedural pain
Time frame: 12 hours
Clinical success
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: Yes. IPD could be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros Spiliopoulos, MD, PhD principal investigator
ATTIKO University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trocar percutaneous cholecystostomy and Seldinger percutaneous cholecystostomy in people with Cholecystitis, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: At the end of the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.