ESTES Snapshot Audit 2018

NCT03610308 | Completed DMC

• 1 other identifier: ESTESSnapshotAudit2018
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangitis; Gallstone; Pancreatitis Gallstone; Cholecystitis; Gangrenous

Outcome Measures

Primary Outcomes (1)

• Mortality

  Overall and disease-related mortality

  60 days

Secondary Outcomes (3)

• ICU Admission

  60 days

• Length of hospital stay

  60 days

• Complications

  60 days

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• Uncomplicated biliary colic
• Biliary dyskinesia
• Acute calculous cholecystitis (AAST Grade I)

Sponsors & Collaborators

• European Society for Trauma and Emergency Surgery: lead

Study Sites (1)

Tallaght University Hospital

Dublin, Ireland

Location

Related Publications (1)

• 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.

  PMID: 33813631 DERIVED

MeSH Terms

Conditions

Cholangitis; Gallstones; Cholecystitis; Gangrene

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Necrosis; Pathologic Processes

Study Officials

• Gary A Bass, MD, MSc, MBA

  Tallaght University Hospital, Dublin, Ireland

  STUDY CHAIR

• Shahin Mohseni, MD, PhD

  Örebro University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

• Jorge Pereira, MD, FACS

  Hospital de São Teotónio, Viseu, Portugal

  PRINCIPAL INVESTIGATOR

• Amy Gillis, MD, MCh, FRCSC

  Tallaght University Hospital, Dublin, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Emergency Surgery Cohort Studies Steering Group

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 1, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: January 31, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

IE (1)