NCT03087747

Brief Summary

In a setting of acute cholecystitis (AC) one of the treatment option is percutaneous transhepatic cholangiography (PTHC) drainage. The goal of current study is to evaluate some radiology aspects and correlate with clinical patient outcomes in patients with acute cholecystitis severity grade III (presented as acute cholecystitis with organ dysfunction).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

4.8 years

First QC Date

March 7, 2017

Last Update Submit

May 28, 2021

Conditions

Cholecystitis, AcuteElderly InfectionDrain Abscess

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein (CRP)

    C-reactive protein (CRP) is a protein found in blood plasma, whose levels rise in response to inflammation.

    Up to 8 weeks.

Secondary Outcomes (2)

  • Drainage duration (expressed in days)

    Up to 16 weeks.

  • White blood cells (WBCs) count

    Up to 8 weeks.

Study Arms (2)

Group 1

Patients older than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC).

Procedure: Percutaneous cholecystostomy

Group 2

Patients younger than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC).

Procedure: Percutaneous cholecystostomy

Interventions

Percutaneous cholecystostomyPROCEDURE

Placement of drainage catheter into gallbladder lumen in order to evacuate inflamed content.

Group 1Group 2

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute cholecystitis

You may qualify if:

  • clinical markers of acute cholecystitis
  • diagnosis confirmed with some imaging technique: computed tomography (CT), ultrasound (US).

You may not qualify if:

  • clinical diagnosis was not confirmed with imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Split, School of Medicine

Split, 21000, Croatia

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Liana Cambj Sapunar, Professor

    University Hospital of Split

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 22, 2017

Study Start

January 1, 2015

Primary Completion

October 1, 2019

Study Completion

May 1, 2020

Last Updated

June 3, 2021

Record last verified: 2021-05

Locations

CR(1)