An observational study in Bile Duct Stones, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Oslo University Hospital · Observational
The BILNOR study is a prospective multicenter observational study evaluating how common bile duct stones are best managed in patients undergoing cholecystectomy. The study focuses particularly on transcystic laparoscopic common bile duct exploration (LCBDE) and assesses stone clearance, technical success, complications, and health-economic outcomes in routine clinical practice. A secondary aim is to compare LCBDE with intraoperative ERCP regarding efficacy, complication rates, and costs. Approximately 340 patients from several Norwegian centers are planned to be included starting in March 2026.
The BILNOR study (Cholecystectomy with intraoperative management of bile duct stones in Norway) is a prospective, multicenter observational study evaluating how common bile duct stones (CBDS) are best managed when patients also need a cholecystectomy. Although ERCP followed by later cholecystectomy is still the most frequently used strategy, it often requires two separate procedures, with additional discomfort, risk, admissions, and costs. Single-stage alternatives-either intraoperative ERCP (including rendezvous techniques) or laparoscopic common bile duct exploration (LCBDE)-may reduce resource use and improve the patient pathway, but are unevenly available across Norwegian hospitals and have differing complication profiles.
The primary focus of BILNOR is transcystic LCBDE, a technique implemented at Oslo University Hospital in 2019 using a structured "step-up" approach (e.g., saline flushing, pharmacologic relaxation, guidewire passage, papillary balloon dilatation up to 8 mm, and transcystic choledochoscopy with stone extraction; intraoperative ERCP if needed/available). The study will estimate real-world stone clearance (defined as no repeat biliary intervention within 90 days), technical success (intraoperative clearance on cholangiography), and 30-day complications including a study-specific definition of post-procedure pancreatitis, as well as bile leak and other Clavien-Dindo graded events. Health economic outcomes (length of stay and costs per patient) and which procedural steps are most often required to achieve clearance are also assessed.
A secondary aim is to compare LCBDE with intraoperative ERCP regarding efficacy, complication rates, and costs, including a non-inferiority assessment for stone clearance. The planned total sample size is approximately 340 patients (155 per group plus allowae for dropouts). Learning-curve effects will be addressed with center-level sensitivity analyses excluding early cases. Inclusion is planned to start March 1, 2026, with expansion to additional centers as the technique spreads in Norway.
88 studies on the registry are indexed under Cholecystolithiasis; 17 are open to participants now.
This study's planned enrollment of 340 is close to the median of 341 across 28 observational studies indexed under Cholecystolithiasis.
Browse Cholecystolithiasis studies →Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.
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Eligible patients will be identified during routine clinical evaluation by the treating surgical team. Either in the outpatient clinic or in the ward for emergency admitted patients.
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Preoperatively image proven choledocholithiasis or bile duct sludge (US / CT / MRI)
Exclusion criteria:
Laparoscopic cholecystectomy and inhtraoperative bile duct clearance.
Laparoscopic cholecystectomy and ERCP
Reintervention rate
Bile duct reintervention rate
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Feb 2031, 60 months after the start.
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