Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study
ConditionBile Duct Stones
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Preoperatively image proven choledocholithiasis or bile duct sludge (US / CT / MRI)
≤ 8 mm size
≤ 5 stones
Disqualifiers
Previous cholecystectomy
Medically unfit for surgery (frailty, comorbidity)
Technically inoperable (hostile abdomen, inflammatory processes, bleeding conditions, cirrhosis)
Pregnancy
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
340 Participants
are grouped into 2 trial groupsGroup A: LC+LCBDE
Group B: LC+IOERCP
Trial outcomes
Primary outcomes
1
Reintervention rate
Bile duct reintervention rate
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov