NCT06330688

Brief Summary

The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress97%
Mar 2024Jun 2026

First Submitted

Initial submission to the registry

February 22, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

February 22, 2024

Last Update Submit

March 19, 2024

Conditions

Cholecystitis, AcuteCholecystitis

Keywords

cholecystostomypercutaneoustrocarultrasoundguidedtechniqueSeldingertranshepatictransperitonealsubcostalintercostaltechnicalsuccesscomplications

Outcome Measures

Primary Outcomes (2)

  • Technical success

    Image verification of correct PC catheter placement within the gallbladder lumen with subsequent bile aspiration at the time of initial catheter placement

    Up to 1 hour

  • Procedure-related complications

    Complications attributed to the procedure

    Up to 3 months

Secondary Outcomes (3)

  • duration of the procedure

    Up to 1 hour

  • intraprocedural and post-procedural pain

    Up to 12 hours

  • clinical success

    Up to 72 hours

Interventions

percutaneous cholecystostomyPROCEDURE

PC is a minimally invasive, nonsurgical, image-guided intervention that aims to drain and decompress the gallbladder by placing a pigtail catheter through the abdominal wall into the gallbladder lumen.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients requiring PC, irrespective of the underlying cause, comorbidities and indication, and irrespective of patient demographics.

You may not qualify if:

  • Patients are going to be excluded from the study if they are younger than 18 years, if they require PC catheter placement under CT guidance (according to the operator's judgement), or if they suffer from severe uncontrollable coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attikon University Hospital

Chaïdári, Athens, 12461, Greece

RECRUITING

Related Publications (4)

  • Arkoudis NA, Moschovaki-Zeiger O, Reppas L, Grigoriadis S, Alexopoulou E, Brountzos E, Kelekis N, Spiliopoulos S. Percutaneous cholecystostomy: techniques and applications. Abdom Radiol (NY). 2023 Oct;48(10):3229-3242. doi: 10.1007/s00261-023-03982-2. Epub 2023 Jun 20.

    PMID: 37338588RESULT

  • Arkoudis NA, Reppas L, Spiliopoulos S. Image-guided percutaneous cholecystostomy: challenging the norms. Abdom Radiol (NY). 2024 Mar;49(3):939-941. doi: 10.1007/s00261-023-04173-9. Epub 2024 Jan 31.

    PMID: 38294540RESULT

  • Arkoudis NA, Moschovaki-Zeiger O, Grigoriadis S, Palialexis K, Reppas L, Filippiadis D, Alexopoulou E, Brountzos E, Kelekis N, Spiliopoulos S. US-guided trocar versus Seldinger technique for percutaneous cholecystostomy (TROSELC II trial). Abdom Radiol (NY). 2023 Jul;48(7):2425-2433. doi: 10.1007/s00261-023-03916-y. Epub 2023 Apr 20.

    PMID: 37081229RESULT

  • Reppas L, Arkoudis NA, Spiliopoulos S, Theofanis M, Kitrou PM, Katsanos K, Palialexis K, Filippiadis D, Kelekis A, Karnabatidis D, Kelekis N, Brountzos E. Two-Center Prospective Comparison of the Trocar and Seldinger Techniques for Percutaneous Cholecystostomy. AJR Am J Roentgenol. 2020 Jan;214(1):206-212. doi: 10.2214/AJR.19.21685. Epub 2019 Oct 1.

    PMID: 31573856RESULT

MeSH Terms

Conditions

Cholecystitis, AcuteCholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Central Study Contacts

Stavros Spiliopoulos, MD, PhD, Associate Professor

CONTACT

+302105831812stavspiliop@gmail.com

Nikolaos Achilleas Arkoudis, MD, PhD

CONTACT

+302105831812nick.arkoudis@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Diagnostic and Interventional Radiology

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 26, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

GR(1)