Routine versus selective bile-duct imaging during gallbladder removal
Official title: ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial
Run by Karolinska Institutet · NCT07002619 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | May 1, 2023 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07002619 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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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.