Brief Title
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
Official Title
Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
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 Type
Interventional
Primary Outcome
Technical success
Secondary Outcome
Duration of the procedure
Condition
Cholecystitis
Intervention
Trocar percutaneous cholecystostomy
Study Arms / Comparison Groups
Group T
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
September 16, 2020
Completion Date
December 16, 2021
Primary Completion Date
September 16, 2021
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
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
Stavros Spiliopoulos, MD, PhD, +302105831832, [email protected]
Location Countries
Greece
Location Countries
Greece
Administrative Informations
NCT ID
NCT04602156
Organization ID
EBD 515/16-9-2020
Responsible Party
Principal Investigator
Study Sponsor
Attikon Hospital
Study Sponsor
Stavros Spiliopoulos, MD, PhD, Principal Investigator, ATTIKO University Hospital
Verification Date
December 2020