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

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ClinicalTrials.gov Identifier: NCT04602156
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Stavros Spiliopoulos, Attikon Hospital

Brief Summary:
A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy

Condition or disease Intervention/treatment Phase
Cholecystitis Procedure: Trocar percutaneous cholecystostomy Procedure: Seldinger percutaneous cholecystostomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : September 16, 2022
Estimated Study Completion Date : December 16, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Technical success [ Time Frame: At the end of the procedure ]
    Image verified catheter placement within the gallbladder and subsequent bile aspiration

  2. Procedure-related complications [ Time Frame: 3 months ]
    Minor or major complications attributed to the procedure


Secondary Outcome Measures :
  1. Duration of the procedure [ Time Frame: Intraprocedural ]
    The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder

  2. Intraprocedural pain [ Time Frame: End of the procedure ]
    pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score

  3. Post-procedural pain [ Time Frame: 12 hours ]
    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)

  4. Clinical success [ Time Frame: 72 hours ]
    Gradual subsidence of signs, symptoms, and elevated inflammatory markers



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602156


Contacts
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Contact: Stavros Spiliopoulos +302105831832 stavspiliop@med.uoa.gr
Contact: Nikolaos Arkoudis +302105831832 nick.arkoudis@gmail.com

Locations
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Greece
"Attikon" University General Hospital Recruiting
Athens, Attiki, Greece, 12461
Contact: Stavros Spiliopoulos, MD, PhD,    6937403468    stavspiliop@med.uoa.gr   
Contact: Nikolaos Arkoudis, MD    6983091554    nick.arkoudis@gmail.com   
Sponsors and Collaborators
Attikon Hospital
Investigators
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Principal Investigator: Stavros Spiliopoulos, MD, PhD ATTIKO University Hospital
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Responsible Party: Stavros Spiliopoulos, Assistant Professor in Interventional Radiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT04602156    
Other Study ID Numbers: EBD 515/16-9-2020
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD could be available upon reasonable request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD could be available after the completion of the study upon reasonable request
Access Criteria: email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stavros Spiliopoulos, Attikon Hospital:
Percutaneous cholecystostomy
ultrasound-guided
interventional radiology
Trocar
Seldinger
Additional relevant MeSH terms:
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Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases