US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy (TROSELCII)

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

Study Overview

• Status: Completed
• Conditions: Cholecystitis
• Intervention / Treatment: Procedure: Trocar percutaneous cholecystostomy; Procedure: Seldinger 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
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12461
      • "ATTIKON" University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Image verified catheter placement within the gallbladder and subsequent bile aspiration	At the end of the procedure
Procedure-related complications	Minor or major complications attributed to the procedure	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the procedure	The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder	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	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)	12 hours
Clinical success	Gradual subsidence of signs, symptoms, and elevated inflammatory markers	72 hours

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Principal Investigator: Stavros Spiliopoulos, MD, PhD, ATTIKO University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound-guided; interventional radiology; Percutaneous cholecystostomy; Seldinger; Trocar
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis
• Other Study ID Numbers: EBD 515/16-9-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No