Protocol for choledocholithiasis at emergency surgerystudy (ProCESS)

Not Applicable

Recruiting

• Conditions: choledocholithiasis; bile duct stones; Surgery - Surgical techniques; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Public Health - Health service research

• Registration Number: ACTRN12620000151932
• Lead Sponsor: Rhys Jones FRCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-13
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

All consecutive patients within unit undergoing emergency laparoscopic cholecystectomy with bile duct stones identified pre or intra-operatively

Exclusion Criteria

Pregnancy
Age >85 years

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cholangitis as defined by the Tokyo Guidelines for Cholangitis.<br>Diagnosis is made on presence of systemic inflammation, evidence of cholestasis on laboratory tests and evidence of biliary pathology on imaging (either computed topography (CT), magnetic resonance cholangiopancreatography or ultrasound).<br><br>Link to Tokyo Guidelines can be found here: https://onlinelibrary.wiley.com/doi/full/10.1002/jhbp.512[By time of outpatient ERCP (within 6-8 weeks)];Pancreatitis, as diagnosed by epigastric pain radiating to back with nausea and one of either a.) elevated serum lipase levels or b.) imaging (CT scan) consistent with pancreatic inflammation [By time of outpatient ERCP (within 6-8 weeks)]