CholecystitisChole_ACCNCT06227936
Complications of Cholecystostomy in ACC
An observational study of Cholecystitis, run by Hospital del Mar.
Trial summary
Acute cholecystitis (AC) is the second most frequent pathology in Surgical Emergencies; laparoscopic cholecystectomy (LC) is the gold standard treatment, but not all patients are fit for surgery at the diagnostic. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 30 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admited with the diagnostic of Acute Cholecystitis from January 2011 to December 2023
Who may be able to join
- All patients admited in the Hospital del Mar with the diagnostic of an Acute Cholecystitis
Who cannot join
- Acute cholangitis
- Acute Pancreatitis
- Neoplasia
- Chronic Cholecystitis
- Patients under 18 yearls old
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Percutaneous Cholecystostomy, Old-fashioned or There is There Still a Role in ACC?
Acute cholecystitis (AC) is the second most frequent pathology in Surgical Emergencies; laparoscopic cholecystectomy (LC) is the gold standard treatment, but not all patients are fit for surgery at the diagnostic. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity.
This study aims to analyse the complications of PC and review its indications in the literature.
Read the detailed description
It is a single-centre retrospective study of 2000 acute cholecystitis in adults from January 2011 to december 2023, including demographyc characteristics, comorbidy severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification,the indicatioons for a PC and local complications of PC.
- Conditions
- Cholecystitis
- Keywords
- Acute Choleystitis, Cholecystostomy, Tokyo Guidelines, Non-Surgical Treatment, Mortality, High-risk patient
- Medical subject headings
- Cholecystitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
The main outcome measure is the complications due to the PC treatment.
Measured: 2011-2023
Mortality
The second main outcome measure is the mortality in patients with an Acute Cholecystitis and its cause.
Measured: 2011-2023
Secondary outcomes (2)
Types of cholecystostomy
There are different indications for cholecystostomy. To do a description of them.
Measured: 2011-2023
Surgical Rescue
To study the patients that needed a surgical treatment and those who could be operated after recovery from sepsis and descrive the outcomes of all of them within the Clavien-Dindo Classification.
Measured: 2011-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 May 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María González Castillo, Hospital del Mar
- Investigators
- Ana María González Castillo, PhD, Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227936
- Sponsor's protocol ID
- Cholecystostomy in ACC
- Acronym
- Chole_ACC
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cholecystostomy, Old-fashioned or There is There Still a Role in ACC?
- ClinicalTrials.gov ID
- NCT06227936
- Acronym / sponsor ID
- Chole_ACC / Cholecystostomy in ACC
- Conditions
- Cholecystitis
- Keywords
- Acute Choleystitis, Cholecystostomy, Tokyo Guidelines, Non-Surgical Treatment, Mortality, High-risk patient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 29 Jan 2024 (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.
Acute cholecystitis (AC) is the second most frequent pathology in Surgical Emergencies; laparoscopic cholecystectomy (LC) is the gold standard treatment, but not all patients are fit for surgery at the diagnostic. Percutaneous Cholecystostomy (PC) is an alternative to LC but has high comorbidity.
This study aims to analyse the complications of PC and review its indications in the literature.
Detailed description
It is a single-centre retrospective study of 2000 acute cholecystitis in adults from January 2011 to december 2023, including demographyc characteristics, comorbidy severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification,the indicatioons for a PC and local complications of PC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admited with the diagnostic of Acute Cholecystitis from January 2011 to December 2023
Key inclusion criteria (1 listed)
- All patients admited in the Hospital del Mar with the diagnostic of an Acute Cholecystitis
Key exclusion criteria (6 listed)
- Acute cholangitis
- Acute Pancreatitis
- Neoplasia
- Chronic Cholecystitis
- Patients under 18 yearls old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications
Time frame: 2011-2023
The main outcome measure is the complications due to the PC treatment.
Mortality
Time frame: 2011-2023
The second main outcome measure is the mortality in patients with an Acute Cholecystitis and its cause.
2 secondary outcomes
Types of cholecystostomy
Time frame: 2011-2023
Surgical Rescue
Time frame: 2011-2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
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Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
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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.
Ana María González Castillo, PhD principal investigator
Hospital del Mar
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, run by Hospital del Mar.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana María González Castillo, PhD (+34665126866, amgonzalezcastillo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 2011-2023). The study lists 2 primary outcomes in all. 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 12 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.