RecruitingNCT07449897

Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study


Sponsor

Oslo University Hospital

Enrollment

340 participants

Start Date

Feb 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • Previous cholecystectomy
  • Medically unfit for surgery (frailty, comorbidity)
  • Technically inoperable (hostile abdomen, inflammatory processes, bleeding conditions, cirrhosis)
  • Pregnancy

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Locations(1)

Oslo University Hospital

Oslo, Norway

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NCT07449897


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