ESTES Snapshot Audit 2018

Completed

• Conditions: Pancreatitis Gallstone; Cholecystitis; Gangrenous; Cholangitis; Gallstone

• Registration Number: NCT03610308
• Lead Sponsor: European Society for Trauma and Emergency Surgery

Brief 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.

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 Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-01
• Study Start: 2018-10-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	60 days	Overall and disease-related mortality

Secondary Outcome Measures

Name	Time	Method
ICU Admission	60 days	Intensive Care Unit admission for organ-supportive therapy
Length of hospital stay	60 days	Length of hospital stay
Complications	60 days	Complication related to surgical, endoscopic or radiologic intervention

Trial Locations

Locations (1)

Tallaght University Hospital; 🇮🇪 Dublin, Ireland