NCT04602156

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

October 20, 2020

Last Update Submit

November 22, 2022

Conditions

Cholecystitis

Keywords

Percutaneous cholecystostomyultrasound-guidedinterventional radiologyTrocarSeldinger

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Duration of the procedure

    Intraprocedural

  • Intraprocedural pain

    End of the procedure

  • Post-procedural pain

    12 hours

  • Clinical success

    72 hours

Study Arms (2)

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.

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.

Procedure: Seldinger percutaneous cholecystostomy

Interventions

Trocar percutaneous cholecystostomyPROCEDURE

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.

Group T
Seldinger percutaneous cholecystostomyPROCEDURE

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.

Group S

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients requiring PC, regardless of the underlying cause.
  • Signed informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Attikon" University General Hospital

Athens, Attica, 12461, Greece

Location

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Stavros Spiliopoulos, MD, PhD

    ATTIKO University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Interventional Radiology

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

September 16, 2020

Primary Completion

November 22, 2022

Study Completion

November 22, 2022

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

IPD could be available upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
IPD could be available after the completion of the study upon reasonable request
Access Criteria
email

Locations

GR(1)