Actively Recruiting
Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis
Led by University of Calgary · Updated on 2026-04-29
2000
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
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 study's main outcome is confirming the presence or absence of choledocholithiasis immediately after evaluation, helping to improve future patient assessment and management.
CONDITIONS
Brief Title
Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Age under 18 years
- Suspected or proven cholangitis
- Previous ERCP with sphincterotomy
- Prior diagnosis or management of choledocholithiasis
- Outpatient status
- Out-of-province status preventing full medical record access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo an endoscopic procedure (ERCP or EUS) to evaluate for suspected choledocholithiasis, with data collected before, during, and immediately after the procedure.
1 visit (in-person procedure and recovery)
Duration - 30 days post-procedure
Participants are contacted by telephone 30 days after the procedure to assess symptoms, adverse events, and any related healthcare visits.
1 telephone call
Duration - 6 months post-procedure
Participants' medical records are reviewed 6 months after the procedure to check for any adverse events, repeat procedures, or hospital visits related to choledocholithiasis.
No visits; medical record review only
Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Actively Recruiting
Research Team
N
Nauzer Forbes, MD, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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