About this trial
Choledocholithiasis (stone(s) in the common bile duct) is common. Untreated or missed, choledocholithiasis has high morbidity and mortality. Endoscopic retrograde cholangio-pancreatography (ERCP) is recognized as the first-line modality for management. While effective, ERCP is associated with adverse events. Thus, the selection of patients for ERCP should be accompanied by a high pre-test suspicion of choledocholithiasis.
Choledocholithiasis is suspected based on clinical, biochemical and radiographic findings. The most relied-upon strategy for risk stratification of choledocholithiasis is based on guidelines from The American Society for Gastrointestinal Endoscopy (ASGE). In it, clinical predictors are defined as "very strong", "strong" or "moderate", and the presence of one or more of these is meant to suggest "high" or "intermediate" probability of choledocholithiasis.
A knowledge gap exists in the performance characteristics of intermediate-probability criteria, where overall accuracy is \<50% from limited data. Patients in this group are recommended to a) undergo endoscopic ultrasound (EUS) or magnetic resonance cholangio-pancreatography (MRCP), b) undergo cholecystectomy with intra-operative cholangiography (IOC), or c) proceed directly to ERCP. At centres where EUS and MRCP are readily available, these are preferred options, as they are least invasive and sensitive; however, they are often unavailable. Thus, in clinical practice, a high proportion of intermediate-risk patients ultimately proceed directly to ERCP, where likelihood of benefit is only moderate, while procedural risk remains.
The role of liver enzyme changes has not been evaluated; however, dynamic changes may offer another method for evaluating patients at intermediate risk of CBD stones that is safe and available. Incorporation of dynamic liver enzymes may improve the test-performance characteristics of the existing framework.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with suspected choledocholithiasis, regardless of probability
age 18 years old or older
able to give informed consent to involvement (in the prospective validation phase).
Disqualifiers
Unable or unwilling to provide informed consent;
age < 18 years;
suspected or proven cholangitis;
previous ERCP with sphincterotomy;
Trial population
Adult patients undergoing ERCP for suspected choledocholithiasis
Trial design
Other
Other
Treatments tested in this trial
Endoscopic Retrograde Cholagiopancreatography (ERCP)
Procedure/SurgeryEndoscopic procedure employed to manage biliary and pancreatic diseases
Treatment groups
Trial outcomes
Primary outcomes
Positive or negative diagnosis of choledocholithiasis
Retrospective analysis will be employed to determine the individual and joint test performance characteristics of the parameters in the ASGE guideline, and to determine the (lone and additional) test characteristics of dynamic enzyme changes, in predicting the primary outcome measure. The agreed-upon model will then be validated prospectively.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.