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

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.

Study Overview

• Status: Recruiting
• Conditions: Bile Duct Stones

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Magnus H Fasting, MD, PhD, FEBS (UGI); Phone Number: 0047 22800000; Email: magfas@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LC+LCBDE; Laparoscopic cholecystectomy and inhtraoperative bile duct clearance.
LC+IOERCP; Laparoscopic cholecystectomy and ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention rate	Bile duct reintervention rate	90 days

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 964437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No