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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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
• 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.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Drain Abscess
• Elderly Infection

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.