Improving Diagnosis and Treatment for Adults with Suspected Common Bile Duct Stones

What this Trial Is About

Choledocholithiasis, the presence of stones in the common bile duct, is a common condition with significant risks if left untreated. This research investigates current methods for detecting and managing choledocholithiasis, focusing especially on patients at intermediate risk where existing guidelines perform with limited accuracy. The study aims to improve diagnosis by incorporating changes in liver enzyme levels alongside established criteria. The study is divided into two phases. The first phase is a retrospective review of about 1,000 patients treated from 2012 to 2017, analyzing medical records, laboratory tests, imaging, and procedures like ERCP and intra-operative cholangiography to refine diagnostic criteria. The second phase is a prospective validation where newly referred inpatient candidates for ERCP or EUS will be asked to participate, with data collected before, during, and after their procedures to evaluate the new diagnostic approach. Participants will undergo standard care procedures like ERCP or EUS, with researchers collecting demographic, clinical, and laboratory data, and monitoring outcomes for up to six months after the procedure. Follow-up includes phone interviews and medical record reviews to track any complications or additional treatments. The studys main outcome is confirming the presence or absence of choledocholithiasis immediately after evaluation, helping to improve future patient assessment and management.

Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis