Cholecystectomy with intraoperative management of bile duct stones in Norway
Official title: Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study
Run by Oslo University Hospital · NCT07449897 · Data updated 2026-11-12
This project will try a single-stage approach—mainly transcystic laparoscopic common bile duct exploration (LCBDE), with intraoperative ERCP if needed—to clear small (≤8 mm) bile duct stones in adults having their gallbladder removed.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 340 (estimated) |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | February 1, 2031 |
| Study ends | December 1, 2036 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT07449897 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with preoperative imaging–confirmed bile duct stones or sludge (≤8 mm, ≤5 stones, not proximal) who are planned for cholecystectomy with intraoperative bile duct clearance and are fit for surgery are ideal candidates.
✕Probably not a fit
Patients with larger or proximal stones, more than five stones, prior cholecystectomy, medically unfit or technically inoperable patients, and pregnant people are unlikely to benefit from the approaches tested here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
BILNOR is a prospective, multicenter observational study across Norwegian hospitals that focuses on intraoperative management of common bile duct stones during planned cholecystectomy. The protocol emphasizes a structured "step-up" transcystic LCBDE approach (saline flushing, pharmacologic relaxation, guidewire passage, papillary balloon dilatation up to 8 mm, and transcystic choledochoscopy with stone extraction), with intraoperative ERCP used when needed or available. Primary outcomes include real-world stone clearance (no repeat biliary intervention within 90 days), intraoperative technical success on cholangiography, and 30-day complications including a study-specific definition of post-procedure pancreatitis, bile leak, and Clavien-Dindo graded events. The study will also collect health-economic measures such as length of stay and cost per patient, aiming to enroll about 340 patients starting March 2026.
Why it matters
Potential benefit: If successful, this approach could reduce the need for two separate procedures, shorten hospital stays, lower costs, and speed patient recovery.
How similar studies have gone: Single-stage strategies like LCBDE and intraoperative ERCP have been used successfully at specialized centers, but comparative real-world multicenter data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age over 18 years * Preoperatively image proven choledocholithiasis or bile duct sludge (US / CT / MRI) * ≤ 8 mm size * ≤ 5 stones * Not proximal bile duct stones * Planned cholecystectomy with intraoperative bile duct clearance (LCBDE or intraoperative ERCP) Exclusion criteria: * Previous cholecystectomy * Medically unfit for surgery (frailty, comorbidity) * Technically inoperable (hostile abdomen, inflammatory processes, bleeding conditions, cirrhosis) * Pregnancy
Where it's running
-
Oslo University Hospital
Oslo, Norway Recruiting
Study contacts
- Study coordinator: Magnus H Fasting, MD, PhD, FEBS (UGI)
- Email: magfas@ous-hf.no
- Phone: 0047 22800000
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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.