Cholangitis; GallstoneNCT03610308
ESTES Snapshot Audit 2018
An observational study of Cholangitis; Gallstone and Pancreatitis Gallstone, run by European Society for Trauma and Emergency Surgery at 1 site in Ireland.
Trial summary
To explore differences in patients, techniques and outcomes across the international cohort to identify areas of practice variability in the presentation and management of acute complicated calculous biliary disease. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Cholangitis; Gallstone, Pancreatitis Gallstone, Cholecystitis; Gangrenous
- How many people
- 250 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2018to 31 Jan 2019
- How long will I take part?
- 60 Days
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Pan-European, prospective audit of consecutive patients admitted for the treatment of complicated calculous biliary disease over a 30-day study period. The audit shall include unscheduled admissions from 1 October 2018 to 31 October 2018. * Commencement timeframe: The sites will start within a time window from 1 October to 31 October 2018. Following commencement, the sites will be required to include all eligible consecutive patients for 30 consecutive days. * Final date for operation inclusion: The sites can include admissions that occur up to 31 October 2018. * All patients will be followed for 60 days post-admission. Data collection should therefore be completed by 31 December 2018. * As this is an observational cohort audit, no change to normal patient management is required.
Who may be able to join
- Adult patients (over 18 years of age) admitted for:
- Acute gangrenous or perforated calculous cholecystitis (AAST Severity Grade II or above)
- Choledocholithiasis or complications of cholelithiasis and/or choledocholithiasis
- Biliary Pancreatitis
- Procedures which should be included:
- Cholecystectomy (open, laparoscopic or robotic)
Show all 13Show fewer
- Choledochotomy/common bile duct exploration (open, laparoscopic or robotic)
- Pancreatic necrosectomy
- Gastrojejunostomy
- Cyst gastrostomy
- Endoscopic retrograde choledochopancreatography (ERCP) or Endoscopic ultrasound (EUS)
- Percutaneous cholecystostomy (transhepatic or transperitoneal)
- Percutaneous transhepatic drainage, stone removal or stent placement
Who cannot join
- Uncomplicated biliary colic
- Biliary dyskinesia
- Acute calculous cholecystitis (AAST Grade I)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2018 - Acute Complicated Biliary Disease
To explore differences in patients, techniques and outcomes across the international cohort to identify areas of practice variability in the presentation and management of acute complicated calculous biliary disease.
Read the detailed description
Background: Acute complications of biliary calculi are common, morbid and complex to manage. Variability exists in the techniques utilised to treat these conditions at a surgeon and unit level. This high-quality pan-European prospective audit will establish current practices and correlate them against outcomes.
Aim: To explore differences in patients, techniques and outcomes across the international cohort to identify areas of practice variability in the presentation and management of acute complicated calculous biliary disease.
Endpoints: A two-stage data collection strategy collecting patient demographics, details of operative, endocopic and radiologic intervention and outcome metrics. Several outcomes measures will be used including mortality, surgical morbidity (including Clavien-Dindo Grade 3a and above), ICU stay and length of hospital stay.
Methods: This 30 day prospective audit will be performed across Europe in late autumn 2018, and will be co-ordinated by the Emergency Surgery Cohort Study committee of European Society of Trauma and Emergency Surgery. This will be preceded by a one-week, three-centre pilot. Sites will be asked to pre-register for the audit and will be required to obtain appropriate regional or national approvals in advance of the enrolment date. The ESTES cohort studies committee will assist sites to register where possible.
During the study period, all eligible patients with acute complicated biliary calculous disease will be recorded contemporaneously and followed-up through to 60 days from their admission. The audit will be performed using a standardised pre-determined protocol and a secure online database. The report of this audit will be prepared in accordance with guidelines set by the STROBE (strengthening the reporting of observational studies in epidemiology) statement for observational studies.
Discussion: This multicentre, pan-European audit of acute complicated biliary calculous disease will be delivered by emergency surgeons and trainees in an organised and homogenous manner. The data obtained about areas of variability in provision or practice, and how this may impact upon outcomes, will serve to improve overall patient care as well as being hypothesis generating and inform areas needing future prospective study.
- Medical subject headings
- Cholangitis, Gallstones, Cholecystitis, Gangrene
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Overall and disease-related mortality
Measured: 60 days
Secondary outcomes (3)
ICU Admission
Intensive Care Unit admission for organ-supportive therapy
Measured: 60 days
Length of hospital stay
Length of hospital stay
Measured: 60 days
Complications
Complication related to surgical, endoscopic or radiologic intervention
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2018
- Study completion31 Jan 2019
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 Cholangitis; GallstoneStudies 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
- 250 participants (actual)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- European Society for Trauma and Emergency Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Alan Bass, European Society for Trauma and Emergency Surgery
- Investigators
- Gary A Bass, MD, MSc, MBA, Study chair, Tallaght University Hospital, Dublin, IrelandShahin Mohseni, MD, PhD, Principal investigator, Örebro University Hospital, SwedenJorge Pereira, MD, FACS, Principal investigator, Hospital de São Teotónio, Viseu, PortugalAmy Gillis, MD, MCh, FRCSC, Principal investigator, Tallaght University Hospital, Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610308
- Sponsor's protocol ID
- ESTESSnapshotAudit2018
- Status last verified
- Jul 2019
- First submitted
- 26 Jul 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bass GA, Gillis AE, Cao Y, Mohseni S; European Society for Trauma and Emergency Surgery (ESTES) Cohort Studies Group. Patients over 65 years with Acute Complicated Calculous Biliary Disease are Treated Differently-Results and Insights from the ESTES Snapshot Audit. World J Surg. 2021 Jul;45(7):2046-2055. doi: 10.1007/s00268-021-06052-0. Epub 2021 Apr 3.
PubMed 33813631
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2018 - Acute Complicated Biliary Disease
- ClinicalTrials.gov ID
- NCT03610308
- Acronym / sponsor ID
- ESTESSnapshotAudit2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- European Society for Trauma and Emergency SurgeryUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 1 Aug 2018 (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.
To explore differences in patients, techniques and outcomes across the international cohort to identify areas of practice variability in the presentation and management of acute complicated calculous biliary disease.
Detailed description
Background: Acute complications of biliary calculi are common, morbid and complex to manage. Variability exists in the techniques utilised to treat these conditions at a surgeon and unit level. This high-quality pan-European prospective audit will establish current practices and correlate them against outcomes.
Aim: To explore differences in patients, techniques and outcomes across the international cohort to identify areas of practice variability in the presentation and management of acute complicated calculous biliary disease.
Endpoints: A two-stage data collection strategy collecting patient demographics, details of operative, endocopic and radiologic intervention and outcome metrics. Several outcomes measures will be used including mortality, surgical morbidity (including Clavien-Dindo Grade 3a and above), ICU stay and length of hospital stay.
Methods: This 30 day prospective audit will be performed across Europe in late autumn 2018, and will be co-ordinated by the Emergency Surgery Cohort Study committee of European Society of Trauma and Emergency Surgery. This will be preceded by a one-week, three-centre pilot. Sites will be asked to pre-register for the audit and will be required to obtain appropriate regional or national approvals in advance of the enrolment date. The ESTES cohort studies committee will assist sites to register where possible.
During the study period, all eligible patients with acute complicated biliary calculous disease will be recorded contemporaneously and followed-up through to 60 days from their admission. The audit will be performed using a standardised pre-determined protocol and a secure online database. The report of this audit will be prepared in accordance with guidelines set by the STROBE (strengthening the reporting of observational studies in epidemiology) statement for observational studies.
Discussion: This multicentre, pan-European audit of acute complicated biliary calculous disease will be delivered by emergency surgeons and trainees in an organised and homogenous manner. The data obtained about areas of variability in provision or practice, and how this may impact upon outcomes, will serve to improve overall patient care as well as being hypothesis generating and inform areas needing future prospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Pan-European, prospective audit of consecutive patients admitted for the treatment of complicated calculous biliary disease over a 30-day study period. The audit shall include unscheduled admissions from 1 October 2018 to 31 October 2018. * Commencement timeframe: The sites will start within a time window from 1 October to 31 October 2018. Following commencement, the sites will be required to include all eligible consecutive patients for 30 consecutive days. * Final date for operation inclusion: The sites can include admissions that occur up to 31 October 2018. * All patients will be followed for 60 days post-admission. Data collection should therefore be completed by 31 December 2018. * As this is an observational cohort audit, no change to normal patient management is required.
Key inclusion criteria (13 listed)
- Procedures which should be included:
Key exclusion criteria (3 listed)
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
Mortality
Time frame: 60 days
Overall and disease-related mortality
3 secondary outcomes
ICU Admission
Time frame: 60 days
Length of hospital stay
Time frame: 60 days
Complications
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 33813631Bass GA, Gillis AE, Cao Y, Mohseni S; European Society for Trauma and Emergency Surgery (ESTES) Cohort Studies Group. Patients over 65 years with Acute Complicated Calculous Biliary Disease are Treated Differently-Results and Insights from the ESTES Snapshot Audit. World J Surg. 2021 Jul;45(7):2046-2055. doi: 10.1007/s00268-021-06052-0. Epub 2021 Apr 3.
- 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.
Gary A Bass, MD, MSc, MBA study chair
Tallaght University Hospital, Dublin, Ireland
Shahin Mohseni, MD, PhD principal investigator
Örebro University Hospital, Sweden
Jorge Pereira, MD, FACS principal investigator
Hospital de São Teotónio, Viseu, Portugal
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 Cholangitis; Gallstone and Pancreatitis Gallstone, run by European Society for Trauma and Emergency Surgery at 1 site in Ireland.
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 13 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jul 2019. 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 Ireland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 60 days). 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 NCT03610308, 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 Jul 2019.