Routine versus selective bile-duct imaging during gallbladder removal
ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
This trial will test whether routinely taking X-ray images of the bile ducts during gallbladder removal or only doing them when needed leads to fewer complications for adults having gallbladder surgery without suspected bile duct stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07002619 on ClinicalTrials.gov |
What this trial studies
This is a national, multicenter randomized registry-based trial in Sweden embedded in the GallRiks registry that randomizes adults undergoing cholecystectomy without preoperative suspicion of common bile duct stones to routine intraoperative cholangiography (IOC) or selective IOC. In the routine arm surgeons perform IOC for all procedures while in the selective arm IOC is performed only when preoperative tests or intraoperative findings suggest stones or unclear anatomy. GallRiks will supply baseline, operative and follow-up data and predefined outcomes include postoperative pancreatitis, cholangitis, bile duct injury, need for ERCP, and overall morbidity and mortality. The registry-based design enables broad real-world enrollment across Swedish hospitals and capture of rare but important adverse events.
Who should consider this trial
Good fit: Adults (18 years or older) undergoing cholecystectomy at participating Swedish hospitals who have no preoperative suspicion of common bile duct stones and who are not pregnant or suspected to have biliary malignancy.
Not a fit: Patients with preoperative evidence of common bile duct stones, children, pregnant patients, or patients with suspected gallbladder or bile duct cancer are excluded and unlikely to benefit from the trial findings.
Why it matters
Potential benefit: If successful, the results could either reduce unnecessary bile-duct procedures and their complications or help avoid missed stones and their harms, improving safety of gallbladder surgery.
How similar studies have performed: Observational and registry studies have shown mixed results on routine versus selective IOC and high-quality randomized evidence is limited, so this pragmatic RCT addresses an important knowledge gap.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing cholecystectomy Exclusion Criteria: * Preoperative suspicion of common bile duct stone * Pregnancy * Age \<18 years * Preoperative suspicion of malignancy in the gallbladder or bile ducts
Where this trial is running
Stockholm
- Ersta Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Camilla Runfors, MD, PhD — Ersta Diakoni
- Study coordinator: Gabriel Sandblom, Associate Professor
- Email: gabriel.sandblom@ki.se
- Phone: +46704158218
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.