Cholecystitis, AcuteNCT03087747
Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes
An observational study of Cholecystitis, Acute and Elderly Infection, run by University of Split, School of Medicine at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholecystitis, Acute, Elderly Infection, Drain Abscess
- What is being tested?
- Percutaneous cholecystostomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jan 2015to 1 May 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with acute cholecystitis
Who may be able to join
- clinical markers of acute cholecystitis
- diagnosis confirmed with some imaging technique: computed tomography (CT), ultrasound (US).
Who cannot join
- clinical diagnosis was not confirmed with imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Drainage in a Setting of Acute Cholecystitis Severity Grade III and Correlation With Clinical Outcomes
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).
- Conditions
- Cholecystitis, Acute, Elderly Infection, Drain Abscess
- Being tested
- Percutaneous cholecystostomy
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous cholecystostomyProcedure or surgery
Placement of drainage catheter into gallbladder lumen in order to evacuate inflamed content.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients older than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC). Receives: Procedure: Percutaneous cholecystostomy | |
| Group 2 | Patients younger than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC). Receives: Procedure: Percutaneous cholecystostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein (CRP)
C-reactive protein (CRP) is a protein found in blood plasma, whose levels rise in response to inflammation.
Measured: Up to 8 weeks.
Secondary outcomes (2)
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.
Measured: Up to 16 weeks.
White blood cells (WBCs) count
White blood cells (WBCs) are the cells of the immune system. During inflammation White blood cell level rise.
Measured: Up to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Jan 2015
- Primary completion1 Oct 2019 (estimated)
- Study completion1 May 2020 (estimated)
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marija Cavar, University of Split, School of Medicine
- Investigators
- Liana Cambj Sapunar, Professor, Study director, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087747
- Sponsor's protocol ID
- AChol
- Status last verified
- May 2021
- First submitted
- 7 Mar 2017
- Last updated
- 3 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Drainage in a Setting of Acute Cholecystitis Severity Grade III and Correlation With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03087747
- Acronym / sponsor ID
- AChol
- Conditions
- Cholecystitis, Acute, Elderly Infection, Drain Abscess
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: poor accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Percutaneous cholecystostomyPatients older than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC). |
| Group 2 | – | Procedure: Percutaneous cholecystostomyPatients younger than 80 yr. Clinical parameters after percutaneous transhepatic cholangiography (PTHC). |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute cholecystitis
Key inclusion criteria (2 listed)
- clinical markers of acute cholecystitis
- diagnosis confirmed with some imaging technique: computed tomography (CT), ultrasound (US).
Key exclusion criteria (1 listed)
- clinical diagnosis was not confirmed with imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous cholecystostomyPlacement of drainage catheter into gallbladder lumen in order to evacuate inflamed content. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
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.
2 secondary outcomes
Drainage duration (expressed in days)
Time frame: Up to 16 weeks.
White blood cells (WBCs) count
Time frame: Up to 8 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liana Cambj Sapunar, Professor study director
University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, Acute and Elderly Infection, run by University of Split, School of Medicine at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein (CRP) (time frame: Up to 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021.