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

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ClinicalTrials.gov Identifier: NCT03087747
Recruitment Status : Unknown
Verified March 2017 by Marija Cavar, University of Split, School of Medicine.
Recruitment status was:  Recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Marija Cavar, University of Split, School of Medicine

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).

Condition or disease Intervention/treatment
Cholecystitis, Acute Elderly Infection Drain Abscess Procedure: Percutaneous cholecystostomy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Percutaneous Drainage in a Setting of Acute Cholecystitis Severity Grade III and Correlation With Clinical Outcomes
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute cholecystitis
Criteria

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.

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): NCT03087747


Contacts
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Contact: Antonia Bralic, MD +38521556265 antonia.scepanovic@gmail.com
Contact: Marija Cavar +38521556265 marija.cavar@mefst.hr

Locations
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Croatia
University of Split, School of Medicine Recruiting
Split, Croatia, 21000
Contact: Marija Cavar, MD    385 21 556265    marija.cavar@mefst.hr   
Sponsors and Collaborators
University of Split, School of Medicine
Investigators
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Study Director: Liana Cambj Sapunar, Professor University Hospital Split
Additional Information:

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Responsible Party: Marija Cavar, MD, University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03087747    
Other Study ID Numbers: AChol
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases