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Trial record 2 of 239548 for:    ALL

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by University of Split, School of Medicine
Sponsor:
Information provided by (Responsible Party):
Marija Cavar, University of Split, School of Medicine
ClinicalTrials.gov Identifier:
NCT03087747
First received: March 7, 2017
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
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 Intervention
Cholecystitis, Acute
Elderly Infection
Drain Abscess
Procedure: Percutaneous cholecystostomy

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Split, School of Medicine:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 50
Actual Study Start Date: January 1, 2015
Estimated Study Completion Date: June 1, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03087747

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

Locations
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
Study Director: Liana Cambj Sapunar, Professor University Hospital Split
  More Information

Responsible Party: Marija Cavar, MD, University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03087747     History of Changes
Other Study ID Numbers: AChol
Study First Received: March 7, 2017
Last Updated: March 21, 2017

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on March 22, 2017