Acute CholecystitisCHOLEPREVNCT04739891
Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors
An observational study of Acute Cholecystitis and Choledocholithiasis, run by Hospital de Mataró.
Trial summary
The management of cholelithiasis with choledocolithiasis is extensively known, whereas for Acute Calculous Cholecystitis (ACC) with choledocolithiasis or common bile duct stones (CBDS), a common entity, there is a lack of protocols for optimising treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Cholecystitis, Choledocholithiasis
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2021to 15 Apr 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who underwent emergent cholecystectomy for acute calculous cholecystitis
Who may be able to join
- Age ≥18 years
Who cannot join
- Non urgent cholecystectomy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors for Its Diagnosis and Management
The management of cholelithiasis with choledocolithiasis is extensively known, whereas for Acute Calculous Cholecystitis (ACC) with choledocolithiasis or common bile duct stones (CBDS), a common entity, there is a lack of protocols for optimising treatment. The main hypothesis of our study is: a correct stratification of the concomitant CBDS probability at ACC diagnosis would optimize its treatment as early targeted treatment could be performed. One-step management of ACC with CBDS by a specialised hepatobiliary team would represent a benefit to the patient in terms of morbi-mortality, admission time and number of admissions. The aim of our study is to identify high / intermediate probability criteria for CBDS associated when diagnosing CA. This is a retrospective study of patients who were operated on with an emergent cholecystectomy in our center from 01/2012 to 12/2019.
Read the detailed description
Data will be obtained from the hospital (Consorci Sanitari del Maresme) clinical database.
The Ethics Committee approval has been obtained.
- Conditions
- Acute Cholecystitis, Choledocholithiasis
- Keywords
- Acute Cholecystitis, Choledocholithiasis, Urgent cholecystectomy, Risk factors
- Medical subject headings
- Cholecystitis, Acute, Choledocholithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
CBDS risk
Probability of CBDS presence at the moment of AC diagnose based on classification on risk modified from Maple et al. 2010: high, intermediate or low
Measured: From diagnostic to surgery
Secondary outcomes (3)
Intraoperative cholangiography
Percentage of patients who underwent intraoperative cholangiography (IOC) in each group: %
Measured: During the surgery
Postoperative morbidity
Adverse events (biliary fistula presence and ERCP (endoscopic retrograde cholangiopancreatography) requirements) identification during the postoperative period: Y/N
Measured: From surgery to 1 year
Readmission
Requirement of readmission after discharge
Measured: From discharge to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start15 Feb 2021 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Ciscar, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739891
- Sponsor's protocol ID
- CHOLEPREV2021
- Acronym
- CHOLEPREV
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x.
PubMed 33153472
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors for Its Diagnosis and Management
- ClinicalTrials.gov ID
- NCT04739891
- Acronym / sponsor ID
- CHOLEPREV / CHOLEPREV2021
- Conditions
- Acute Cholecystitis, Choledocholithiasis
- Keywords
- Acute Cholecystitis, Choledocholithiasis, Urgent cholecystectomy, Risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 5 Feb 2021 (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.
The management of cholelithiasis with choledocolithiasis is extensively known, whereas for Acute Calculous Cholecystitis (ACC) with choledocolithiasis or common bile duct stones (CBDS), a common entity, there is a lack of protocols for optimising treatment. The main hypothesis of our study is: a correct stratification of the concomitant CBDS probability at ACC diagnosis would optimize its treatment as early targeted treatment could be performed. One-step management of ACC with CBDS by a specialised hepatobiliary team would represent a benefit to the patient in terms of morbi-mortality, admission time and number of admissions. The aim of our study is to identify high / intermediate probability criteria for CBDS associated when diagnosing CA. This is a retrospective study of patients who were operated on with an emergent cholecystectomy in our center from 01/2012 to 12/2019.
Detailed description
Data will be obtained from the hospital (Consorci Sanitari del Maresme) clinical database.
The Ethics Committee approval has been obtained.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who underwent emergent cholecystectomy for acute calculous cholecystitis
Key inclusion criteria (1 listed)
- Age ≥18 years
Key exclusion criteria (1 listed)
- Non urgent cholecystectomy
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
CBDS risk
Time frame: From diagnostic to surgery
Probability of CBDS presence at the moment of AC diagnose based on classification on risk modified from Maple et al. 2010: high, intermediate or low
3 secondary outcomes
Intraoperative cholangiography
Time frame: During the surgery
Postoperative morbidity
Time frame: From surgery to 1 year
Readmission
Time frame: From discharge to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Background: PubMed 33153472Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis and Choledocholithiasis, run by Hospital de Mataró.
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 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: status not confirmed, as of the sponsor's last update on 5 Feb 2021. 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 Ciscar, Mrs (0034937417700 ext. 1141, aciscar@casdm.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBDS risk (time frame: From diagnostic to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04739891, which also lists 1 linked publication.
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 5 Feb 2021.