Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes

May 28, 2021 updated by: Marija Cavar, University of Split, School of Medicine

Percutaneous Drainage in a Setting of Acute Cholecystitis Severity Grade III and Correlation With Clinical Outcomes

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • University of Split, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with acute cholecystitis

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • clinical diagnosis was not confirmed with imaging.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients older than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC).
Procedure: Percutaneous cholecystostomy
Placement of drainage catheter into gallbladder lumen in order to evacuate inflamed content.
Group 2
Patients younger than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC).
Procedure: Percutaneous cholecystostomy
Placement of drainage catheter into gallbladder lumen in order to evacuate inflamed content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein (CRP)
Time Frame: Up to 8 weeks.
C-reactive protein (CRP) is a protein found in blood plasma, whose levels rise in response to inflammation.
Up to 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drainage duration (expressed in days)
Time Frame: Up to 16 weeks.
The drain which is placed in gallbladder during Percutaneous transhepatic cholangiography (PTHC) remains there until resolving clinical parameters of acute cholecystitis.
Up to 16 weeks.
White blood cells (WBCs) count
Time Frame: Up to 8 weeks.
White blood cells (WBCs) are the cells of the immune system. During inflammation White blood cell level rise.
Up to 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

Investigators

  • Study Director: Liana Cambj Sapunar, Professor, University Hospital Split

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AChol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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