US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy (TROSELCII)
Primary Purpose
Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Trocar percutaneous cholecystostomy
Seldinger percutaneous cholecystostomy
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring Percutaneous cholecystostomy, ultrasound-guided, interventional radiology, Trocar, Seldinger
Eligibility Criteria
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
Sites / Locations
- "Attikon" University General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group T
Group S
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Technical success
Image verified catheter placement within the gallbladder and subsequent bile aspiration
Procedure-related complications
Minor or major complications attributed to the procedure
Secondary Outcome Measures
Duration of the procedure
The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder
Intraprocedural pain
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
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
Gradual subsidence of signs, symptoms, and elevated inflammatory markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04602156
Brief Title
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
Acronym
TROSELCII
Official Title
Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
November 22, 2022 (Actual)
Study Completion Date
November 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
Keywords
Percutaneous cholecystostomy, ultrasound-guided, interventional radiology, Trocar, Seldinger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group T
Arm Type
Experimental
Arm Description
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.
Arm Title
Group S
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Trocar percutaneous cholecystostomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Seldinger percutaneous cholecystostomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical success
Description
Image verified catheter placement within the gallbladder and subsequent bile aspiration
Time Frame
At the end of the procedure
Title
Procedure-related complications
Description
Minor or major complications attributed to the procedure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Duration of the procedure
Description
The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder
Time Frame
Intraprocedural
Title
Intraprocedural pain
Description
pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score
Time Frame
End of the procedure
Title
Post-procedural pain
Description
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)
Time Frame
12 hours
Title
Clinical success
Description
Gradual subsidence of signs, symptoms, and elevated inflammatory markers
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Spiliopoulos, MD, PhD
Organizational Affiliation
ATTIKO University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Attikon" University General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
12461
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD could be available upon reasonable request
IPD Sharing Time Frame
IPD could be available after the completion of the study upon reasonable request
IPD Sharing Access Criteria
email
Learn more about this trial
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
We'll reach out to this number within 24 hrs