ESTES Snapshot Audit 2018

Cholecystitis; Gangrenous Clinical Trial

Official title:

European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2018 - Acute Complicated Biliary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610308
• Other study ID #: ESTESSnapshotAudit2018
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: July 2019
• Source: European Socierty for Trauma and Emergency Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

• Inclusion Criteria:

• 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:

1. Cholecystectomy (open, laparoscopic or robotic)

2. Choledochotomy/common bile duct exploration (open, laparoscopic or robotic)

3. Pancreatic necrosectomy

4. Gastrojejunostomy

5. Cyst gastrostomy

6. Endoscopic retrograde choledochopancreatography (ERCP) or Endoscopic ultrasound (EUS)

7. Percutaneous cholecystostomy (transhepatic or transperitoneal)

8. Percutaneous transhepatic drainage, stone removal or stent placement

• Exclusion Criteria:

• Uncomplicated biliary colic

• Biliary dyskinesia

• Acute calculous cholecystitis (AAST Grade I)

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis; Gallstone
• Cholecystitis
• Cholecystitis; Gangrenous
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Pancreatitis
• Pancreatitis Gallstone

Locations

Country	Name	City	State
Ireland	Tallaght University Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
European Socierty for Trauma and Emergency Surgery

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Overall and disease-related mortality	60 days
Secondary	ICU Admission	Intensive Care Unit admission for organ-supportive therapy	60 days
Secondary	Length of hospital stay	Length of hospital stay	60 days
Secondary	Complications	Complication related to surgical, endoscopic or radiologic intervention	60 days