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

Withdrawn

• Conditions: Cholecystitis, Acute; Elderly Infection; Drain Abscess
• Interventions: Procedure: Percutaneous cholecystostomy

• Registration Number: NCT03087747
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-22
• Primary Completion: 2019-10-01
• Study Completion: 2020-05-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Percutaneous cholecystostomy	Patients older than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC).
Group 2	Percutaneous cholecystostomy	Patients younger than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC).

Primary Outcome Measures

Name	Time	Method
C-reactive protein (CRP)	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

Name	Time	Method
White blood cells (WBCs) count	Up to 8 weeks.	White blood cells (WBCs) are the cells of the immune system. During inflammation White blood cell level rise.
Drainage duration (expressed in days)	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.

Trial Locations

Locations (1)

University of Split, School of Medicine; 🇭🇷 Split, Croatia