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NCT03087747 Clinical Trial

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

Cholecystitis, Acute Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03087747
Other study ID # AChol
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date May 1, 2020

Study information
Verified date May 2021
Source University of Split, School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 1, 2020
Est. primary completion date October 1, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Percutaneous cholecystostomy
Placement of drainage catheter into gallbladder lumen in order to evacuate inflamed content.

Locations
Country Name City State
Croatia University of Split, School of Medicine Split

Sponsors (1)
Lead Sponsor Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Drainage duration (expressed in days) 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.
Secondary White blood cells (WBCs) count White blood cells (WBCs) are the cells of the immune system. During inflammation White blood cell level rise. Up to 8 weeks.
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