Improving evaluation and management of patients with suspected bile duct stones
Official title: Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis
Run by University of Calgary · NCT05141916 · Data updated 2026-11-12
This study is testing a new way to improve how doctors check for and treat patients who might have stones in their bile duct.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Status | Recruiting |
| Started | February 25, 2019 |
| Main results expected | December 31, 2028 |
| Study ends | June 30, 2029 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT05141916 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are suspected of having choledocholithiasis, regardless of the probability of the condition.
✕Probably not a fit
Patients who are unable or unwilling to provide informed consent, those under 18 years of age, or individuals with suspected or proven cholangitis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to optimize the evaluation and management of patients suspected of having choledocholithiasis, which involves stones in the common bile duct. The study will consist of two phases: a retrospective evaluation of 1,000 patients from 2012 to 2017 to assess the performance of current guidelines, followed by a prospective validation of a new model that incorporates dynamic liver enzyme changes into the management algorithm. The goal is to enhance the accuracy of risk stratification for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
Why it matters
Potential benefit: If successful, this study could lead to improved patient outcomes by ensuring that only those with a high likelihood of choledocholithiasis undergo ERCP, thereby reducing unnecessary procedures and associated risks.
How similar studies have gone: Other studies have shown success in optimizing management strategies for choledocholithiasis, but this specific approach incorporating dynamic liver enzyme changes is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Unable or unwilling to provide informed consent; * age \< 18 years; * suspected or proven cholangitis; * previous ERCP with sphincterotomy; * prior diagnosis or management of choledocholithiasis; * outpatient status; * out-of-province status (prohibiting full medical record access).
Where it's running
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University of Calgary
Calgary, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Nauzer Forbes, MD, MSc — University of Calgary
- Study coordinator: Nauzer Forbes, MD, MSc
- Email: nauzer.forbes@ucalgary.ca
- Phone: 403-592-5089
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
This study tests whether giving hyoscine butylbromide during laparoscopic transcystic papillary balloon dilation helps patients with common bile duct stones by making the procedure faster or easier.
-
Holmium laser versus electrohydraulic lithotripsy for difficult bile duct and pancreatic duct stones
This will test whether a low-power holmium laser works and is as safe as electrohydraulic lithotripsy for adults with large or hard-to-remove bile duct or pancreatic duct stones.
-
Intraductal antibiotic given during ERCP for acute cholangitis
This trial tests whether putting an antibiotic directly into the bile ducts during ERCP, together with standard IV antibiotics, helps adults with mild-to-moderate acute cholangitis recover faster and avoid worsening infection compared with IV antibiotics alone.
-
Comparing the carbon footprint of endoscopic ultrasound versus MRCP for suspected common bile duct stones
This project will test whether endoscopic ultrasound (EUS) produces a smaller carbon footprint than MRCP when used to check for common bile duct (CBD) stones in adults with intermediate risk.
-
Early versus late laparoscopic gallbladder removal after clearing common bile duct stones with ERCP
This trial will test whether having your gallbladder removed soon after ERCP or waiting longer gives better outcomes for people who had stones cleared from their common bile duct.
-
One-stage laparoendoscopic approach for gallbladder and common bile duct stones
This trial tests whether a single-operation laparoendoscopic 'rendezvous' approach—combining laparoscopic gallbladder removal with endoscopic bile duct clearance—works safely and effectively for patients with both gallbladder and common bile duct stones.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.